JOB PURPOSE This position will report directly to a Sr. Scientist in the In Vivo Research group within the department of Gene Therapy. The Senior Research Associate (SRA) will have three primary responsibilities: (1) to execute in vivo studies to support gene therapy research programs at Sana, (2) to carry out cell and tissue preparation work related to in vivo studies, and (3) to support needs across the Gene Therapy organization. The position will also require close communication and collaboration with research groups at Sana outside of the Gene Therapy organization. PRIMARY RESPONSIBILITIES Work closely with the Sr. Scientist to plan and execute in vivo studies Tissue collection and processing for downstream assays such as flow cytometry, histology and molecular work Support in vitro work (e.g. cell culture) to enable in vivo studies Data recording, analysis and reporting using proper software (e.g. Prism, FlowJo) and electronic notebook Presentation of data to the team Participate in creating a collaborative, rewarding work environment QUALIFICATIONS Required Qualifications BS in biology or related discipline and 4+ years or 2+ years/MS of relevant research experience in an industry or academic setting Experience with standard molecular biology and cell biology techniques: RNA isolation and reverse-transcription, qPCR, mammalian cell culture, staining for Flow Cytometry and Lentivirus transduction Experience in working with mice: handling, injections (IV, IP, SC), bleeding, tissue harvest Experience in developing in vitro and in vivo assays and deploying at scale in a collaborative research environment Demonstrated experience with relevant software: Microsoft Word, Excel, PowerPoint, Graphpad Prism, FlowJo software Strong interpersonal skills and adaptable communication style Strong organizational, record keeping, and data documentation skills Excellent oral and written communication skills, attention to detail and data quality, and experience working on diverse collaborative teams Preferred Qualifications BS or MS degree in immunology Experience in T cell immunology and/or Hematopoietic Stem Cells Experience with immune cell profiling using flow cytometry techniques
03/05/2021
Full time
JOB PURPOSE This position will report directly to a Sr. Scientist in the In Vivo Research group within the department of Gene Therapy. The Senior Research Associate (SRA) will have three primary responsibilities: (1) to execute in vivo studies to support gene therapy research programs at Sana, (2) to carry out cell and tissue preparation work related to in vivo studies, and (3) to support needs across the Gene Therapy organization. The position will also require close communication and collaboration with research groups at Sana outside of the Gene Therapy organization. PRIMARY RESPONSIBILITIES Work closely with the Sr. Scientist to plan and execute in vivo studies Tissue collection and processing for downstream assays such as flow cytometry, histology and molecular work Support in vitro work (e.g. cell culture) to enable in vivo studies Data recording, analysis and reporting using proper software (e.g. Prism, FlowJo) and electronic notebook Presentation of data to the team Participate in creating a collaborative, rewarding work environment QUALIFICATIONS Required Qualifications BS in biology or related discipline and 4+ years or 2+ years/MS of relevant research experience in an industry or academic setting Experience with standard molecular biology and cell biology techniques: RNA isolation and reverse-transcription, qPCR, mammalian cell culture, staining for Flow Cytometry and Lentivirus transduction Experience in working with mice: handling, injections (IV, IP, SC), bleeding, tissue harvest Experience in developing in vitro and in vivo assays and deploying at scale in a collaborative research environment Demonstrated experience with relevant software: Microsoft Word, Excel, PowerPoint, Graphpad Prism, FlowJo software Strong interpersonal skills and adaptable communication style Strong organizational, record keeping, and data documentation skills Excellent oral and written communication skills, attention to detail and data quality, and experience working on diverse collaborative teams Preferred Qualifications BS or MS degree in immunology Experience in T cell immunology and/or Hematopoietic Stem Cells Experience with immune cell profiling using flow cytometry techniques
JOB PURPOSE We are seeking an experienced development Toxicologist to join our Pharmacology/Toxicology group. The qualified candidate is a highly motivated, interactive, and creative individual that has demonstrated expertise in drug development to work across a highly matrixed environment to advance translational efforts. This role is integral to driving discovery research into the clinic, including exploratory, pilot, and pivotal toxicology studies and health authority interactions. This person is responsible for the overall strategy and conduct of the studies supporting a Project Team and is thus an expert on study process and specialist needs for cell and gene therapy products. The candidate will be expected to work collaboratively within Development Sciences and to liaise closely with the Project teams to develop Toxicology strategies for advancement to the clinic. The role reports to the VP of Toxicology/Pathology/Biodistribution and brings strategic input to Senior Management to align and advance corporate goals and milestones. DUTIES AND RESPONSIBILITIES Sit as representative for Toxicology on Project and Core Teams and guide, develop, and drive the Toxicology strategy for the team Work collaboratively with Research, Pharmacology, Pathology, CMC, and Bioanalytical scientists to progress therapeutics through the pipeline from discovery to launch Provide internal expertise to understand the mechanisms of toxicity observed non-clinically and/or clinically in order to drive mitigation and/or back-up strategies to minimize potential harm to patients Responsible for building and maintaining effective CRO relationships that support the execution of non-GLP and GLP toxicology/biodistribution studies Review study protocols and draft PI and study reports, provide feedback to Study Director or PI's as needed and responsible for report finalization Liaise with Associate Director of Non-clinical Operations for oversight and monitoring of studies at CRO's Present data and interpretations in written and oral form Write regulatory summaries for safety pharmacology, biodistribution, and toxicology data sets for submissions in the US and ex-US (eg. IND, CTA, BLA, briefing books, Investigator Brochures etc) Working knowledge of code of federal regulations (eg. CFR 21 Part 11 and Part 58 etc) and regulatory guidance's (eg. FDA, EMA, ICH etc) as it pertains to the strategic planning and conduct of safety packages to support first-in-human (FIH) testing Build collaborative networks both internal and external to the company to ensure rapid communication and cross-functional evaluations and investigation Represent SANA Bio in the external scientific environment QUALIFICATIONS Basic Qualifications Bachelors in a scientific discipline with a PhD or DVM and 10+ years of experience in a pharmaceutical/biotech setting Prior role in multidisciplinary projects and teams with ability to integrate cross-functional information, desired Demonstrated ability in developing and implementing toxicology strategies for teams including species selection, biodistribution, target organ identification, and selection and justification of maximum tolerated dose or NOAEL Strong scientific writing skills to prepare and review non-clinical sections (eCTD Modules 2.4 and 2.6) for IND or CTA submission, preparation of briefing books (Interact or Pre-IND), Investigator Brochures, BLA etc Strong collaboration and relationship building and decision-making skills Demonstrated subject matter expert in regulatory toxicology Working knowledge of regulatory needs for conduct of both non-GLP and GLP studies Experience with outsourcing and conducting safety studies at CROs Familiarity with regulatory requirements for cell or gene therapies or similar novel biotherapeutics Familiarity with presenting strategy to teams or management, aligning and achieving buy-in for strategic approach including risk-based approach Preferred Qualifications Ph.D. in toxicology, pathology, comparative biology, molecular pathology, immunology, virology, or a related field, DABT or equivalent Experience with managing CRO relationships and collaborating with KOL's would be advantageous Familiarity with developing Toxicology strategies for cell and gene therapies and CART therapies Experience advancing cell and or viral vector-based gene therapies a plus Demonstrated skills in critical thinking, problem solving, and mechanistic investigation evidenced by scientific publications or presentations a plus
01/28/2021
Full time
JOB PURPOSE We are seeking an experienced development Toxicologist to join our Pharmacology/Toxicology group. The qualified candidate is a highly motivated, interactive, and creative individual that has demonstrated expertise in drug development to work across a highly matrixed environment to advance translational efforts. This role is integral to driving discovery research into the clinic, including exploratory, pilot, and pivotal toxicology studies and health authority interactions. This person is responsible for the overall strategy and conduct of the studies supporting a Project Team and is thus an expert on study process and specialist needs for cell and gene therapy products. The candidate will be expected to work collaboratively within Development Sciences and to liaise closely with the Project teams to develop Toxicology strategies for advancement to the clinic. The role reports to the VP of Toxicology/Pathology/Biodistribution and brings strategic input to Senior Management to align and advance corporate goals and milestones. DUTIES AND RESPONSIBILITIES Sit as representative for Toxicology on Project and Core Teams and guide, develop, and drive the Toxicology strategy for the team Work collaboratively with Research, Pharmacology, Pathology, CMC, and Bioanalytical scientists to progress therapeutics through the pipeline from discovery to launch Provide internal expertise to understand the mechanisms of toxicity observed non-clinically and/or clinically in order to drive mitigation and/or back-up strategies to minimize potential harm to patients Responsible for building and maintaining effective CRO relationships that support the execution of non-GLP and GLP toxicology/biodistribution studies Review study protocols and draft PI and study reports, provide feedback to Study Director or PI's as needed and responsible for report finalization Liaise with Associate Director of Non-clinical Operations for oversight and monitoring of studies at CRO's Present data and interpretations in written and oral form Write regulatory summaries for safety pharmacology, biodistribution, and toxicology data sets for submissions in the US and ex-US (eg. IND, CTA, BLA, briefing books, Investigator Brochures etc) Working knowledge of code of federal regulations (eg. CFR 21 Part 11 and Part 58 etc) and regulatory guidance's (eg. FDA, EMA, ICH etc) as it pertains to the strategic planning and conduct of safety packages to support first-in-human (FIH) testing Build collaborative networks both internal and external to the company to ensure rapid communication and cross-functional evaluations and investigation Represent SANA Bio in the external scientific environment QUALIFICATIONS Basic Qualifications Bachelors in a scientific discipline with a PhD or DVM and 10+ years of experience in a pharmaceutical/biotech setting Prior role in multidisciplinary projects and teams with ability to integrate cross-functional information, desired Demonstrated ability in developing and implementing toxicology strategies for teams including species selection, biodistribution, target organ identification, and selection and justification of maximum tolerated dose or NOAEL Strong scientific writing skills to prepare and review non-clinical sections (eCTD Modules 2.4 and 2.6) for IND or CTA submission, preparation of briefing books (Interact or Pre-IND), Investigator Brochures, BLA etc Strong collaboration and relationship building and decision-making skills Demonstrated subject matter expert in regulatory toxicology Working knowledge of regulatory needs for conduct of both non-GLP and GLP studies Experience with outsourcing and conducting safety studies at CROs Familiarity with regulatory requirements for cell or gene therapies or similar novel biotherapeutics Familiarity with presenting strategy to teams or management, aligning and achieving buy-in for strategic approach including risk-based approach Preferred Qualifications Ph.D. in toxicology, pathology, comparative biology, molecular pathology, immunology, virology, or a related field, DABT or equivalent Experience with managing CRO relationships and collaborating with KOL's would be advantageous Familiarity with developing Toxicology strategies for cell and gene therapies and CART therapies Experience advancing cell and or viral vector-based gene therapies a plus Demonstrated skills in critical thinking, problem solving, and mechanistic investigation evidenced by scientific publications or presentations a plus
JOB PURPOSE Sana is seeking an exceptional Senior Leader to join our dynamic and growing team supporting CMC development of novel gene and cell therapy drug substances and products. The Senior Director of Process & Platform Operations is a key leadership position within Sana Technical Operations as we prepare to advance a pipeline of next-generation gene and cell therapy products to the clinic. The role will lead and build a team of production associates, engineers and scientists to provide technical leadership to establish operations for production and supply of material from research through Phase 1 GMP for novel gene therapy (viral vector) products. The team, led by this role, will establish efficient production operations to supply early research material supply, critical materials (GLP tox), and enable GMP supply by leading tech transfer to GMP manufacturing. The role has technical accountability and oversight for supply of materials from internal or external (CMO) GMP facilities, partnering with process development, analytical, and GMP manufacturing teams. The role will engage in Sana's enterprise-level manufacturing and supply chain planning, including the build out of internal GMP capabilities and external supply chain networks. In this capacity, the Leader will contribute to line-of-sight for life cycle management, with focus on process/technology improvements to the platform and assessment of product comparability. With a strong focus on both technical and operational excellence, this senior hands-on managerial position will play a leading role in shaping core production technology platforms at Sana and the advancement of therapeutic gene therapy candidates from Research into the clinic. This role represents an exciting and unique opportunity to shape the early CMC development paradigm for advanced therapies. DUTIES AND RESPONSIBILITIES The leader will oversee activities in support of early supply of quality research materials to guide pre-clinical candidate selection. With a mindset toward accelerating development, the leader will embrace both science and manufacturability to define and operationalize efficient production platforms for material supply across the early development horizon from candidate selection through to Phase 1 IND. The leader in this role will manage an operations team to supply early research, pilot scale supply and GLP study material supply, tech transfer and process establishment in GMP. The leader will participate with process and analytical development in early process characterization with an eye toward de-risking and troubleshooting production operations, use of scaledown models, and new manufacturing technology exploration. The role will be a member of the Manufacturing network leadership team and will contribute to and influence gene therapy manufacturing and network strategies, and standards for both drug substance and drug product production. The role will work closely with Process & Analytical Development, Quality, External Manufacturing, Supply Chain and CMC/product lifecycle teams to advance our pipeline and establish a robust development network for new products. The role will be viewed as a technical thought leader internally and externally in manufacturing viral vectors and complex biologics. The successful candidate will have industrial experience managing a process development team for biologics/vaccines (and/or preferably gene/cell therapy) and manufacturing operations, have a passion for delivering results and making an impact, an interest in technology and commitment to learning, and be an extraordinary collaborator in a dynamic setting. The ideal leader will shape strategy, build the capability, drive for operational excellence and continuous improvement, and manage a high-performing and growing team. Responsibilities: Establish scientifically-sound and operationally-efficient production workflows for supply of quality research-grade viral vectors for early research studies. Oversee a research production capability to support production of novel viral vector compositions for research customers, perform early optimization & manufacturability assessments, manage a lean industrial workflow to supply small-volume and high-quality vectors in line with business/customer expectations of turnaround time and capacity. Establish the requirements for the clinical manufacturing process for viral vector and ensure application of these requirements throughout the product life cycle. Leveraging a platform mindset to achieve speed and efficiency, establish processes at scale and define an approach for rapid introduction of new candidates. Be accountable for technical success of process operations in the supply of GLP and GMP material. Identify opportunities to shape both the technology platform and manufacturing operations to build a platform within Sana to increase speed, gain efficiency, increase probability of success of supply, reduce cost, and ensure quality in meeting program deliverables across the Sana portfolio of programs. As with other advanced therapies, critical attention to raw materials is a key consideration. Transfer processes developed to internal/external manufacturing sites. This includes ensuring clear definition of the clinical manufacturing control strategy and associated enabling documents/validation or supporting technical studies. Advise on developmental studies needed to ensure successful transfer and de-risking of clinical operations. Engage with Process & Analytical Development to ensure sound process qualification, control and comparability strategies are in place to support the programs. Review/author technical sections of major regulatory documents and contribute to the overall CMC strategy for vector technologies. Participate in the CMO selection process by evaluating CMO capabilities against technical requirements. Provide technical support of the CMOs for deviation management, lot disposition, batch record reviews to ensure that technical issues stay off the critical path for reliable supply. Participate in appropriate internal and joint CMO governance meetings (ex, joint steering committees). Ensure mitigation plans for significant technical risks at the CMOs or key raw material suppliers Hire and manage a team of scientists to define, operationalize, and maintain production workflows. Contribute to build-out of early product and process insights. With a focus on technical excellence, the individual will oversee production activities and their: implementation, performance, troubleshooting, and trending. With a focus on operational excellence, the individual will oversee the design, delivery, and continuous improvement of sample and analytical data workflows to address the needs of the business from the standpoint of: turnaround time, testing capacity, quality, and cost. Participate in establishment of drug substance and drug product specifications and provide technical leadership in review of content for regulatory interactions. QUALIFICATIONS Basic Qualifications Bachelors plus 12+ yrs or equivalent combination of education and work experience; expert knowledge of bioprocess principals and practice; a technical and people leader with experience managing department(s) with mid-level and senior employees. Experience with the following cell culture, purification, chromatography, clarification technologies, tangential flow and normal filtration, aseptic processing and drug product, process automation, high-throughput process development, automated liquid handling, electronic notebooks. Prior experience leading a team in Process Development, pilot scale production, tech transfer, and/or GMP manufacturing is important for success in the position. Must have exceptional organizational skills, preferably with advanced practical experience (+/-certification) in operational excellence or the management of complex workflows using Lean or Six Sigma. Solid understanding of relevant regulatory agency guidance such as FDA, ICH and EMA and hand-on experience. Ability to work in a fast-paced growth environment, and to prioritize work from multiple projects. Demonstrates a respect for others and is open to new/different ideas. Excellent written and verbal communication skills. Preferred Qualifications Bachelors plus 15 yrs or equivalent combination of education and work experience; expert knowledge of principals and concepts and is a thought leader; has experience managing department(s) with senior employees. Organizational leader with experience managing a team of direct (and indirect) reports in technical development of CMC (analytical, process, or formulation) packages for IND/CTA submission. Demonstrated track record, broad experience, and demonstrated success in process development and operations for complex biological products.
01/27/2021
Full time
JOB PURPOSE Sana is seeking an exceptional Senior Leader to join our dynamic and growing team supporting CMC development of novel gene and cell therapy drug substances and products. The Senior Director of Process & Platform Operations is a key leadership position within Sana Technical Operations as we prepare to advance a pipeline of next-generation gene and cell therapy products to the clinic. The role will lead and build a team of production associates, engineers and scientists to provide technical leadership to establish operations for production and supply of material from research through Phase 1 GMP for novel gene therapy (viral vector) products. The team, led by this role, will establish efficient production operations to supply early research material supply, critical materials (GLP tox), and enable GMP supply by leading tech transfer to GMP manufacturing. The role has technical accountability and oversight for supply of materials from internal or external (CMO) GMP facilities, partnering with process development, analytical, and GMP manufacturing teams. The role will engage in Sana's enterprise-level manufacturing and supply chain planning, including the build out of internal GMP capabilities and external supply chain networks. In this capacity, the Leader will contribute to line-of-sight for life cycle management, with focus on process/technology improvements to the platform and assessment of product comparability. With a strong focus on both technical and operational excellence, this senior hands-on managerial position will play a leading role in shaping core production technology platforms at Sana and the advancement of therapeutic gene therapy candidates from Research into the clinic. This role represents an exciting and unique opportunity to shape the early CMC development paradigm for advanced therapies. DUTIES AND RESPONSIBILITIES The leader will oversee activities in support of early supply of quality research materials to guide pre-clinical candidate selection. With a mindset toward accelerating development, the leader will embrace both science and manufacturability to define and operationalize efficient production platforms for material supply across the early development horizon from candidate selection through to Phase 1 IND. The leader in this role will manage an operations team to supply early research, pilot scale supply and GLP study material supply, tech transfer and process establishment in GMP. The leader will participate with process and analytical development in early process characterization with an eye toward de-risking and troubleshooting production operations, use of scaledown models, and new manufacturing technology exploration. The role will be a member of the Manufacturing network leadership team and will contribute to and influence gene therapy manufacturing and network strategies, and standards for both drug substance and drug product production. The role will work closely with Process & Analytical Development, Quality, External Manufacturing, Supply Chain and CMC/product lifecycle teams to advance our pipeline and establish a robust development network for new products. The role will be viewed as a technical thought leader internally and externally in manufacturing viral vectors and complex biologics. The successful candidate will have industrial experience managing a process development team for biologics/vaccines (and/or preferably gene/cell therapy) and manufacturing operations, have a passion for delivering results and making an impact, an interest in technology and commitment to learning, and be an extraordinary collaborator in a dynamic setting. The ideal leader will shape strategy, build the capability, drive for operational excellence and continuous improvement, and manage a high-performing and growing team. Responsibilities: Establish scientifically-sound and operationally-efficient production workflows for supply of quality research-grade viral vectors for early research studies. Oversee a research production capability to support production of novel viral vector compositions for research customers, perform early optimization & manufacturability assessments, manage a lean industrial workflow to supply small-volume and high-quality vectors in line with business/customer expectations of turnaround time and capacity. Establish the requirements for the clinical manufacturing process for viral vector and ensure application of these requirements throughout the product life cycle. Leveraging a platform mindset to achieve speed and efficiency, establish processes at scale and define an approach for rapid introduction of new candidates. Be accountable for technical success of process operations in the supply of GLP and GMP material. Identify opportunities to shape both the technology platform and manufacturing operations to build a platform within Sana to increase speed, gain efficiency, increase probability of success of supply, reduce cost, and ensure quality in meeting program deliverables across the Sana portfolio of programs. As with other advanced therapies, critical attention to raw materials is a key consideration. Transfer processes developed to internal/external manufacturing sites. This includes ensuring clear definition of the clinical manufacturing control strategy and associated enabling documents/validation or supporting technical studies. Advise on developmental studies needed to ensure successful transfer and de-risking of clinical operations. Engage with Process & Analytical Development to ensure sound process qualification, control and comparability strategies are in place to support the programs. Review/author technical sections of major regulatory documents and contribute to the overall CMC strategy for vector technologies. Participate in the CMO selection process by evaluating CMO capabilities against technical requirements. Provide technical support of the CMOs for deviation management, lot disposition, batch record reviews to ensure that technical issues stay off the critical path for reliable supply. Participate in appropriate internal and joint CMO governance meetings (ex, joint steering committees). Ensure mitigation plans for significant technical risks at the CMOs or key raw material suppliers Hire and manage a team of scientists to define, operationalize, and maintain production workflows. Contribute to build-out of early product and process insights. With a focus on technical excellence, the individual will oversee production activities and their: implementation, performance, troubleshooting, and trending. With a focus on operational excellence, the individual will oversee the design, delivery, and continuous improvement of sample and analytical data workflows to address the needs of the business from the standpoint of: turnaround time, testing capacity, quality, and cost. Participate in establishment of drug substance and drug product specifications and provide technical leadership in review of content for regulatory interactions. QUALIFICATIONS Basic Qualifications Bachelors plus 12+ yrs or equivalent combination of education and work experience; expert knowledge of bioprocess principals and practice; a technical and people leader with experience managing department(s) with mid-level and senior employees. Experience with the following cell culture, purification, chromatography, clarification technologies, tangential flow and normal filtration, aseptic processing and drug product, process automation, high-throughput process development, automated liquid handling, electronic notebooks. Prior experience leading a team in Process Development, pilot scale production, tech transfer, and/or GMP manufacturing is important for success in the position. Must have exceptional organizational skills, preferably with advanced practical experience (+/-certification) in operational excellence or the management of complex workflows using Lean or Six Sigma. Solid understanding of relevant regulatory agency guidance such as FDA, ICH and EMA and hand-on experience. Ability to work in a fast-paced growth environment, and to prioritize work from multiple projects. Demonstrates a respect for others and is open to new/different ideas. Excellent written and verbal communication skills. Preferred Qualifications Bachelors plus 15 yrs or equivalent combination of education and work experience; expert knowledge of principals and concepts and is a thought leader; has experience managing department(s) with senior employees. Organizational leader with experience managing a team of direct (and indirect) reports in technical development of CMC (analytical, process, or formulation) packages for IND/CTA submission. Demonstrated track record, broad experience, and demonstrated success in process development and operations for complex biological products.
JOB PURPOSE This position will report directly to a Sr. Scientist in the In Vivo Research group within the department of Gene Therapy. The Senior Research Associate (SRA) will have three primary responsibilities: (1) to execute in vivo studies to support gene therapy research programs at Sana, (2) to carry out cell and tissue preparation work related to in vivo studies, and (3) to support needs across the Gene Therapy organization. The position will also require close communication and collaboration with research groups at Sana outside of the Gene Therapy organization. PRIMARY RESPONSIBILITIES Work closely with the Sr. Scientist to plan and execute in vivo studies Tissue collection and processing for downstream assays such as flow cytometry, histology and molecular work Support in vitro work (e.g. cell culture) to enable in vivo studies Data recording, analysis and reporting using proper software (e.g. Prism, FlowJo) and electronic notebook Presentation of data to the team Participate in creating a collaborative, rewarding work environment QUALIFICATIONS Required Qualifications BS in biology or related discipline and 4+ years or 2+ years/MS of relevant research experience in an industry or academic setting Experience with standard molecular biology and cell biology techniques: RNA isolation and reverse-transcription, qPCR, mammalian cell culture, staining for Flow Cytometry and Lentivirus transduction Experience in working with mice: handling, injections (IV, IP, SC), bleeding, tissue harvest Experience in developing in vitro and in vivo assays and deploying at scale in a collaborative research environment Demonstrated experience with relevant software: Microsoft Word, Excel, PowerPoint, Graphpad Prism, FlowJo software Strong interpersonal skills and adaptable communication style Strong organizational, record keeping, and data documentation skills Excellent oral and written communication skills, attention to detail and data quality, and experience working on diverse collaborative teams Preferred Qualifications BS or MS degree in immunology Experience in T cell immunology and/or Hematopoietic Stem Cells Experience with immune cell profiling using flow cytometry techniques
01/26/2021
Full time
JOB PURPOSE This position will report directly to a Sr. Scientist in the In Vivo Research group within the department of Gene Therapy. The Senior Research Associate (SRA) will have three primary responsibilities: (1) to execute in vivo studies to support gene therapy research programs at Sana, (2) to carry out cell and tissue preparation work related to in vivo studies, and (3) to support needs across the Gene Therapy organization. The position will also require close communication and collaboration with research groups at Sana outside of the Gene Therapy organization. PRIMARY RESPONSIBILITIES Work closely with the Sr. Scientist to plan and execute in vivo studies Tissue collection and processing for downstream assays such as flow cytometry, histology and molecular work Support in vitro work (e.g. cell culture) to enable in vivo studies Data recording, analysis and reporting using proper software (e.g. Prism, FlowJo) and electronic notebook Presentation of data to the team Participate in creating a collaborative, rewarding work environment QUALIFICATIONS Required Qualifications BS in biology or related discipline and 4+ years or 2+ years/MS of relevant research experience in an industry or academic setting Experience with standard molecular biology and cell biology techniques: RNA isolation and reverse-transcription, qPCR, mammalian cell culture, staining for Flow Cytometry and Lentivirus transduction Experience in working with mice: handling, injections (IV, IP, SC), bleeding, tissue harvest Experience in developing in vitro and in vivo assays and deploying at scale in a collaborative research environment Demonstrated experience with relevant software: Microsoft Word, Excel, PowerPoint, Graphpad Prism, FlowJo software Strong interpersonal skills and adaptable communication style Strong organizational, record keeping, and data documentation skills Excellent oral and written communication skills, attention to detail and data quality, and experience working on diverse collaborative teams Preferred Qualifications BS or MS degree in immunology Experience in T cell immunology and/or Hematopoietic Stem Cells Experience with immune cell profiling using flow cytometry techniques
Sana Biotechnology
South San Francisco, California
JOB PURPOSE Sana Biotechnology has an exciting opportunity for a Senior Research Associate within the Cell Therapy Process Development group. The Senior Research Associate will focus on the development of a novel chimeric antigen receptor T (CAR T) cell manufacturing process. Under the supervision of the process development lead, the candidate will perform experiments to support the development of multiple unit operations including cell selection and expansion, gene editing, and cryopreservation. The Senior Research Associate is expected to closely collaborate with multiple teams including Analytical Development. DUTIES AND RESPONSIBILITIES Perform small- and large-scale cell therapy experiments using primary cells across multiple unit operations including cell selection, expansion, gene editing, cell harvest and cryopreservation Perform in-process analysis of samples including cell counting and metabolite analysis Document all experimental work in an electronic laboratory notebook Analyze data and present conclusions to a multidisciplinary group Draft technical documents including reports, operating procedures and master batch records Execute various parts of established processes by adhering to established procedures QUALIFICATIONS Basic Qualifications BSc. in Biology, Biochemistry or related field plus 4 yrs or MSc. plus 1-2 yrs or equivalent combination of education and work experience >2 yrs of experience with mammalian cell culture Excellent aseptic cell culture technique and good scientific method Detail-oriented with good problem-solving, technical writing and verbal communication skills Ability to effectively work in multidisciplinary teams, meet deadlines, and prioritize multiple projects Aptitude for working in a self-driven, performance/results-oriented, fast-paced matrix environment Ability to engage in crucial conversations - providing and receiving feedback The candidate should be a team player, highly organized with excellent communication skills, demonstrate curiosity and scientific rigor and excellent problem-solving skills Preferred Qualifications Prior experience working on a clinical or commercial cell therapy manufacturing process Knowledge of immunology with focus on T cell biology Experience with cell therapy unit operations including: Cell selection T cell culture Viral and non-viral gene editing methods Cell washing and harvesting Cryopreservation Experience with analytical methods including: Cell counts and viability using automated cell counters Media metabolite analysis Flow cytometry Cell-based assays, including Incucyte system Demonstrate technical curiosity and a continuous drive to learn new skills Experience following and drafting controlled documents Knowledge of R, Python, JMP, Spotfire, Benchling and FlowJo software WORKING CONDITIONS This position requires handling of human blood products Some weekend work required Work in a laboratory environment approximately 75% of the time PHYSICAL REQUIREMENTS Able to lift up to 25 lb.
01/25/2021
Full time
JOB PURPOSE Sana Biotechnology has an exciting opportunity for a Senior Research Associate within the Cell Therapy Process Development group. The Senior Research Associate will focus on the development of a novel chimeric antigen receptor T (CAR T) cell manufacturing process. Under the supervision of the process development lead, the candidate will perform experiments to support the development of multiple unit operations including cell selection and expansion, gene editing, and cryopreservation. The Senior Research Associate is expected to closely collaborate with multiple teams including Analytical Development. DUTIES AND RESPONSIBILITIES Perform small- and large-scale cell therapy experiments using primary cells across multiple unit operations including cell selection, expansion, gene editing, cell harvest and cryopreservation Perform in-process analysis of samples including cell counting and metabolite analysis Document all experimental work in an electronic laboratory notebook Analyze data and present conclusions to a multidisciplinary group Draft technical documents including reports, operating procedures and master batch records Execute various parts of established processes by adhering to established procedures QUALIFICATIONS Basic Qualifications BSc. in Biology, Biochemistry or related field plus 4 yrs or MSc. plus 1-2 yrs or equivalent combination of education and work experience >2 yrs of experience with mammalian cell culture Excellent aseptic cell culture technique and good scientific method Detail-oriented with good problem-solving, technical writing and verbal communication skills Ability to effectively work in multidisciplinary teams, meet deadlines, and prioritize multiple projects Aptitude for working in a self-driven, performance/results-oriented, fast-paced matrix environment Ability to engage in crucial conversations - providing and receiving feedback The candidate should be a team player, highly organized with excellent communication skills, demonstrate curiosity and scientific rigor and excellent problem-solving skills Preferred Qualifications Prior experience working on a clinical or commercial cell therapy manufacturing process Knowledge of immunology with focus on T cell biology Experience with cell therapy unit operations including: Cell selection T cell culture Viral and non-viral gene editing methods Cell washing and harvesting Cryopreservation Experience with analytical methods including: Cell counts and viability using automated cell counters Media metabolite analysis Flow cytometry Cell-based assays, including Incucyte system Demonstrate technical curiosity and a continuous drive to learn new skills Experience following and drafting controlled documents Knowledge of R, Python, JMP, Spotfire, Benchling and FlowJo software WORKING CONDITIONS This position requires handling of human blood products Some weekend work required Work in a laboratory environment approximately 75% of the time PHYSICAL REQUIREMENTS Able to lift up to 25 lb.
JOB PURPOSE Sana Biotechnology is looking to expand our team with hard-working individuals who believe in the potential of cells as engineered medicines, have the vision to do creative things, and the determination to execute upon that vision. As a member of the In Vitro Pharmacology and Biomarker Discovery group, you will work within a highly dynamic and cross-functional environment on projects of diverse scope and across multiple therapeutic areas. To accelerate the development of transformative medicines, we seek a Senior Research Associate to build essential platform capabilities as well as develop and implement functional assays to support biomarker discovery, IND enabling studies, platform and research programs. The Senior Research Associate will perform in vitro characterizations of lead gene and cell therapy candidates in complex pharmacological and clinically relevant models. He/She will have experience culturing a diverse array of primary cell types and experience establishing and phenotypically characterizing in vitro models of disease. The successful candidate will have demonstrated technical proficiency, exhibit scientific rigor and independent thought as well as the ability to thrive in a team-oriented environment. DUTIES AND RESPONSIBILITIES Uses professional concepts in accordance with company objectives to solve problems in creative and effective ways. Culture and maintain multiple primary cell types including but not limited to hepatocytes, T-cells, PBMC's, splenocytes, cardiomyocytes, as well as endothelial and stromal cell types. Establish and validate in vitro functional assays using a variety of platforms (high-content imaging, incucyte, flow cytometry, ELISA, MSD, Luminex, HTRF, qPCR) Responsible for thoughtful planning, coordination and execution of experiments. Makes detailed observations, interpret results and document experimental methods in a well-maintained laboratory notebook. Proven ability to work independently. Presents results at team meetings. Facilitates discussion with other team members as necessary to ensure the completion of the team's projects. Comply with standard laboratory practices and company policies QUALIFICATIONS Basic Qualifications Master's degree or Bachelor's degree with 3-4+ years of laboratory experience in an academic or industry setting and proven proficiency performing independent research. Extensive hands-on experience culturing mammalian cell lines (primary and immortalized) with demonstrated competence in sterile cell culture technique and standard laboratory procedures. Experience developing and characterizing in vitro models of disease. Experience in the development of cell-based assays using a variety of platforms (Incucyte, High-content imaging, TR-FRET, ELISA, MSD, Flow Cytometry, Luminex, qPCR). Ability to proactively engage groups with diverse functions within a highly matrixed organization. Excellent oral and written communication skills, attention to detail and data quality, and experience working on cross-functional teams. Technical proficiency, scientific creativity, independent thought and ability to actively communicate with scientists throughout the organization. Preferred Qualifications Industry experience Experience with primary cell culture is highly preferred. Research experience in liver biology and/or immunology. Experience characterizing metabolic pathways and disease modeling
01/23/2021
Full time
JOB PURPOSE Sana Biotechnology is looking to expand our team with hard-working individuals who believe in the potential of cells as engineered medicines, have the vision to do creative things, and the determination to execute upon that vision. As a member of the In Vitro Pharmacology and Biomarker Discovery group, you will work within a highly dynamic and cross-functional environment on projects of diverse scope and across multiple therapeutic areas. To accelerate the development of transformative medicines, we seek a Senior Research Associate to build essential platform capabilities as well as develop and implement functional assays to support biomarker discovery, IND enabling studies, platform and research programs. The Senior Research Associate will perform in vitro characterizations of lead gene and cell therapy candidates in complex pharmacological and clinically relevant models. He/She will have experience culturing a diverse array of primary cell types and experience establishing and phenotypically characterizing in vitro models of disease. The successful candidate will have demonstrated technical proficiency, exhibit scientific rigor and independent thought as well as the ability to thrive in a team-oriented environment. DUTIES AND RESPONSIBILITIES Uses professional concepts in accordance with company objectives to solve problems in creative and effective ways. Culture and maintain multiple primary cell types including but not limited to hepatocytes, T-cells, PBMC's, splenocytes, cardiomyocytes, as well as endothelial and stromal cell types. Establish and validate in vitro functional assays using a variety of platforms (high-content imaging, incucyte, flow cytometry, ELISA, MSD, Luminex, HTRF, qPCR) Responsible for thoughtful planning, coordination and execution of experiments. Makes detailed observations, interpret results and document experimental methods in a well-maintained laboratory notebook. Proven ability to work independently. Presents results at team meetings. Facilitates discussion with other team members as necessary to ensure the completion of the team's projects. Comply with standard laboratory practices and company policies QUALIFICATIONS Basic Qualifications Master's degree or Bachelor's degree with 3-4+ years of laboratory experience in an academic or industry setting and proven proficiency performing independent research. Extensive hands-on experience culturing mammalian cell lines (primary and immortalized) with demonstrated competence in sterile cell culture technique and standard laboratory procedures. Experience developing and characterizing in vitro models of disease. Experience in the development of cell-based assays using a variety of platforms (Incucyte, High-content imaging, TR-FRET, ELISA, MSD, Flow Cytometry, Luminex, qPCR). Ability to proactively engage groups with diverse functions within a highly matrixed organization. Excellent oral and written communication skills, attention to detail and data quality, and experience working on cross-functional teams. Technical proficiency, scientific creativity, independent thought and ability to actively communicate with scientists throughout the organization. Preferred Qualifications Industry experience Experience with primary cell culture is highly preferred. Research experience in liver biology and/or immunology. Experience characterizing metabolic pathways and disease modeling
Sana Biotechnology is seeking a creative and highly motivated individual to join the T-cell therapeutics team who will help bring gene and cell therapies to patients. This individual will be responsible for comprehensive execution of a research-stage in vivo program to test and advance T-cell based therapies. Experiments will be carried out in both xenograft and syngeneic murine models, using both cell and gene therapeutic candidates. In addition to animal manipulation and sample collection, this individual will process biological samples to assess therapeutic efficacy using a variety of techniques. Success in this role will require active collaboration with internal immunology team members as well as other members of the gene therapy, pharmacology, and process development teams. DUTIES AND RESPONSIBILITIES Comprehensive execution of in vivo experiments in multiple xenograft and syngeneic murine models to test efficacy of candidate T-cell therapeutics Contribute to the design of experiments for in vivo testing of therapies in collaboration with team members and program leadership Animal manipulation, sample collection, as well as processing and analysis of tissue samples using a variety of techniques including flow cytometry, qPCR, ddPCR, and other molecular and cell biology techniques Staying up to date with current knowledge to enable onboarding and implementation of state-of-the-art innovative and novel animal models Collaborate with pharmacology and toxicology teams to support IND-enabling studies Function as an independent individual contributor while working closely with other members of the T-cell therapeutics, gene therapy, pharmacology, and process development teams to share and apply knowledge advancements Provide mentorship to others through active engagement of junior team members and by presentation and discussion of scientific results Reviewing and presenting data cross-functionally at department meetings and larger forums Comply with standard laboratory practices and company policies, including notebook documentation and biosafety policies Contribute to the overall Sana mission and culture QUALIFICATIONS Basic Qualifications A BS or MS in a relevant discipline with a minimum of 5-7 years of relevant experience and proven proficiency in design and execution of in vivo experiments as well as sample assessment using a variety of laboratory techniques Previous experience with xenograft and syngeneic murine cancer models, including animal handling as well as sample collection and processing Familiarity and experience with CAR-T based therapeutic development and evaluation Familiarity and experience with handling and delivery of viral vector-based products Demonstrated expertise in novel animal model development and implementation, including the development and generation of humanized mouse models Familiarity and proficiency with multiple routes of injection (i.m., i.p., i.v., etc.) and administration, tissue and blood collection techniques, as well as live-imaging techniques for monitoring of cell populations in vivo Advanced experience with characterization and assay of immune cell populations using state-of-the-art techniques (e.g. Spectral flow cytometry) AALAS certification is desirable A strong self-starter, independent thinker, with a strong attention to detail Experienced with interpersonal skills and an ability to adapt communication style to interact effectively with a range of collaborators including research associates, external technical experts, cell biologists, and therapeutic project teams Excellent oral and written communication skills, attention to detail and data quality, and experience working on diverse collaborative teams Ability to travel 10% of the time
01/21/2021
Full time
Sana Biotechnology is seeking a creative and highly motivated individual to join the T-cell therapeutics team who will help bring gene and cell therapies to patients. This individual will be responsible for comprehensive execution of a research-stage in vivo program to test and advance T-cell based therapies. Experiments will be carried out in both xenograft and syngeneic murine models, using both cell and gene therapeutic candidates. In addition to animal manipulation and sample collection, this individual will process biological samples to assess therapeutic efficacy using a variety of techniques. Success in this role will require active collaboration with internal immunology team members as well as other members of the gene therapy, pharmacology, and process development teams. DUTIES AND RESPONSIBILITIES Comprehensive execution of in vivo experiments in multiple xenograft and syngeneic murine models to test efficacy of candidate T-cell therapeutics Contribute to the design of experiments for in vivo testing of therapies in collaboration with team members and program leadership Animal manipulation, sample collection, as well as processing and analysis of tissue samples using a variety of techniques including flow cytometry, qPCR, ddPCR, and other molecular and cell biology techniques Staying up to date with current knowledge to enable onboarding and implementation of state-of-the-art innovative and novel animal models Collaborate with pharmacology and toxicology teams to support IND-enabling studies Function as an independent individual contributor while working closely with other members of the T-cell therapeutics, gene therapy, pharmacology, and process development teams to share and apply knowledge advancements Provide mentorship to others through active engagement of junior team members and by presentation and discussion of scientific results Reviewing and presenting data cross-functionally at department meetings and larger forums Comply with standard laboratory practices and company policies, including notebook documentation and biosafety policies Contribute to the overall Sana mission and culture QUALIFICATIONS Basic Qualifications A BS or MS in a relevant discipline with a minimum of 5-7 years of relevant experience and proven proficiency in design and execution of in vivo experiments as well as sample assessment using a variety of laboratory techniques Previous experience with xenograft and syngeneic murine cancer models, including animal handling as well as sample collection and processing Familiarity and experience with CAR-T based therapeutic development and evaluation Familiarity and experience with handling and delivery of viral vector-based products Demonstrated expertise in novel animal model development and implementation, including the development and generation of humanized mouse models Familiarity and proficiency with multiple routes of injection (i.m., i.p., i.v., etc.) and administration, tissue and blood collection techniques, as well as live-imaging techniques for monitoring of cell populations in vivo Advanced experience with characterization and assay of immune cell populations using state-of-the-art techniques (e.g. Spectral flow cytometry) AALAS certification is desirable A strong self-starter, independent thinker, with a strong attention to detail Experienced with interpersonal skills and an ability to adapt communication style to interact effectively with a range of collaborators including research associates, external technical experts, cell biologists, and therapeutic project teams Excellent oral and written communication skills, attention to detail and data quality, and experience working on diverse collaborative teams Ability to travel 10% of the time
JOB PURPOSE We are seeking a passionate and detail-oriented laboratory scientist with experience in mammalian or pluripotent stem cell culture to join a growing cell differentiation team. Under the supervision of a Senior Director, the associate will be responsible for daily tasks involving the growth, differentiation, and characterization of pluripotent stem cells to support cell-based therapeutic programs. DUTIES AND RESPONSIBILITIES Culture and differentiation of pluripotent stem cells. Analysis of differentiated cell products (Flow cytometry, PCR, fluorescent microscopy, etc). Participate in the planning, design and execution of experiments. Make observations, interpret results and document experimental methods in a well-maintained laboratory notebook. Present results of experiments and findings in informal, small group settings. Coordinate with other team members as necessary to ensure the completion of the team's research projects. Comply with standard laboratory practices and company policies. QUALIFICATIONS Bachelors' degree in a scientific discipline with experience usually garnered during a minimum of 2+ years of laboratory experience- including internship and co-op experience. Demonstrated expertise in basic laboratory techniques and functions is required as is proficiency in common office software (typically Microsoft Word, Excel and PowerPoint). Prior experience with mammalian cell culture is required; experience with pluripotent cell culture is preferred.
01/19/2021
Full time
JOB PURPOSE We are seeking a passionate and detail-oriented laboratory scientist with experience in mammalian or pluripotent stem cell culture to join a growing cell differentiation team. Under the supervision of a Senior Director, the associate will be responsible for daily tasks involving the growth, differentiation, and characterization of pluripotent stem cells to support cell-based therapeutic programs. DUTIES AND RESPONSIBILITIES Culture and differentiation of pluripotent stem cells. Analysis of differentiated cell products (Flow cytometry, PCR, fluorescent microscopy, etc). Participate in the planning, design and execution of experiments. Make observations, interpret results and document experimental methods in a well-maintained laboratory notebook. Present results of experiments and findings in informal, small group settings. Coordinate with other team members as necessary to ensure the completion of the team's research projects. Comply with standard laboratory practices and company policies. QUALIFICATIONS Bachelors' degree in a scientific discipline with experience usually garnered during a minimum of 2+ years of laboratory experience- including internship and co-op experience. Demonstrated expertise in basic laboratory techniques and functions is required as is proficiency in common office software (typically Microsoft Word, Excel and PowerPoint). Prior experience with mammalian cell culture is required; experience with pluripotent cell culture is preferred.
JOB PURPOSE Sana is seeking an exceptional Senior Leader to join our dynamic and growing team supporting CMC development of novel gene and cell therapy drug substances and products. The Senior Leader of Analytical Development will oversee the establishment of analytical methods and their intensive application for product and process characterization in early development; by leveraging automation / high-throughput testing and data analysis. With a strong focus on both technical and operational excellence, this senior managerial position will play a leading role in shaping core technology platforms at Sana and the advancement of therapeutic gene and cell therapy candidates from Research into the clinic. This role represents an exciting and unique opportunity to shape the early CMC development paradigm for advance therapies. DUTIES AND RESPONSIBILITIES The experienced leader in this role will build a world-class capability with an expert analytical team to drive product and process understanding. The leader will manage assay establishment, automation, testing operations, and data analysis across a portfolio of technologies. The leader will partner closely with process and formulation development to guide strategy and manage analytical development in order to design quality into the Phase 1 CMC packages for novel gene and cell therapies. The individual will play a key role in building out the control strategy for Sana's investigational products, and also participate in cross-functional program teams. The successful candidate will have industrial experience managing an analytical development team for biologics/vaccines (and/or preferably gene/cell therapy), have a passion for delivering results and making an impact, an interest in technology and commitment to learning, and be an extraordinary collaborator in a dynamic setting. The ideal leader will shape strategy, build the capability, drive for operational excellence and continuous improvement, and manage a high-performing team. Responsibilities: Develop/oversee strategy for staged deployment of analytical methods and testing during early platform technology and CMC development. With innovation and pragmatism, accelerate the learning curve and long-term success of developing innovative new products by (1) supplying advanced analytical capabilities (with high volume and rapid turnaround time) to guide research & early CMC development, (2) enabling early and deep insights into quality attributes and process parameters, (3) critically informing the selection/optimization of product candidates, and (4) supporting the rapid translation of product candidates into the clinic. Build and manage a high-throughput / automated testing capability (non-GMP) to support CMC development of Sana's gene and cell therapy programs. Adapt methods for the throughput and technical demands of fast-paced early development programs. Assay families will include: biochemical, molecular biology (PCR, ddPCR), immunoassays (ELISA), cell-based (flow cytometry), and biophysical. Hire and manage a team of scientists to develop, operationalize, and oversee analytical methods and their application in building product insight and solving complex process and formulation development challenges. With a focus on technical excellence, the individual will oversee assay optimization, implementation, performance, troubleshooting, and analysis of results. With a focus on operational excellence, the individual will oversee the design, delivery, and continuous improvement of sample and analytical data workflows to address the needs of the business from the standpoint of: turnaround time, testing capacity, quality, and cost. Participate in establishment of drug substance and drug product specifications for IND, IMPD, and BLA submissions. Review/author protocols, reports, and analytical sections of regulatory submissions (IND, IMPD, BLA). QUALIFICATIONS Basic Qualifications Bachelors plus 12+ yrs or equivalent combination of education and work experience; expert knowledge of principals and concepts and is a leader; has experience managing department(s) with mid level and senior employees. Experience with the following methods /technologies: cellular, biochemical and molecular biological (PCR, ddPCR) methods, immunological methods (ELISA, MSD), spectroscopic and fluorescent methods, flow cytometry, HPLC, automated liquid handling, electronic notebooks. Prior experience leading a team in Analytical method development, testing, QC, or stability is important for success in the position. Must have exceptional organizational skills, preferably with advanced practical experience (+/-certification) in operational excellence or the management of complex workflows using Lean or Six Sigma. Solid understanding of relevant regulatory agency guidance such as FDA, ICH and EMA and hand-on experience. Ability to work in a fast-paced growth environment, and to prioritize work from multiple projects. Demonstrates a respect for others and is open to new/different ideas. Excellent written and verbal communication skills. Preferred Qualifications Bachelors plus 15 yrs or equivalent combination of education and work experience; expert knowledge of principals and concepts and is a thought leader; has experience managing department(s) with senior employees. Organizational leader with experience managing a team of direct (and indirect) reports in technical development of CMC (analytical, process, or formulation) packages for IND/CTA submission. Demonstrated track record, broad experience, and demonstrated success in analytical sciences for characterization of biological products, associated product-related species, and process residuals/impurities.
01/19/2021
Full time
JOB PURPOSE Sana is seeking an exceptional Senior Leader to join our dynamic and growing team supporting CMC development of novel gene and cell therapy drug substances and products. The Senior Leader of Analytical Development will oversee the establishment of analytical methods and their intensive application for product and process characterization in early development; by leveraging automation / high-throughput testing and data analysis. With a strong focus on both technical and operational excellence, this senior managerial position will play a leading role in shaping core technology platforms at Sana and the advancement of therapeutic gene and cell therapy candidates from Research into the clinic. This role represents an exciting and unique opportunity to shape the early CMC development paradigm for advance therapies. DUTIES AND RESPONSIBILITIES The experienced leader in this role will build a world-class capability with an expert analytical team to drive product and process understanding. The leader will manage assay establishment, automation, testing operations, and data analysis across a portfolio of technologies. The leader will partner closely with process and formulation development to guide strategy and manage analytical development in order to design quality into the Phase 1 CMC packages for novel gene and cell therapies. The individual will play a key role in building out the control strategy for Sana's investigational products, and also participate in cross-functional program teams. The successful candidate will have industrial experience managing an analytical development team for biologics/vaccines (and/or preferably gene/cell therapy), have a passion for delivering results and making an impact, an interest in technology and commitment to learning, and be an extraordinary collaborator in a dynamic setting. The ideal leader will shape strategy, build the capability, drive for operational excellence and continuous improvement, and manage a high-performing team. Responsibilities: Develop/oversee strategy for staged deployment of analytical methods and testing during early platform technology and CMC development. With innovation and pragmatism, accelerate the learning curve and long-term success of developing innovative new products by (1) supplying advanced analytical capabilities (with high volume and rapid turnaround time) to guide research & early CMC development, (2) enabling early and deep insights into quality attributes and process parameters, (3) critically informing the selection/optimization of product candidates, and (4) supporting the rapid translation of product candidates into the clinic. Build and manage a high-throughput / automated testing capability (non-GMP) to support CMC development of Sana's gene and cell therapy programs. Adapt methods for the throughput and technical demands of fast-paced early development programs. Assay families will include: biochemical, molecular biology (PCR, ddPCR), immunoassays (ELISA), cell-based (flow cytometry), and biophysical. Hire and manage a team of scientists to develop, operationalize, and oversee analytical methods and their application in building product insight and solving complex process and formulation development challenges. With a focus on technical excellence, the individual will oversee assay optimization, implementation, performance, troubleshooting, and analysis of results. With a focus on operational excellence, the individual will oversee the design, delivery, and continuous improvement of sample and analytical data workflows to address the needs of the business from the standpoint of: turnaround time, testing capacity, quality, and cost. Participate in establishment of drug substance and drug product specifications for IND, IMPD, and BLA submissions. Review/author protocols, reports, and analytical sections of regulatory submissions (IND, IMPD, BLA). QUALIFICATIONS Basic Qualifications Bachelors plus 12+ yrs or equivalent combination of education and work experience; expert knowledge of principals and concepts and is a leader; has experience managing department(s) with mid level and senior employees. Experience with the following methods /technologies: cellular, biochemical and molecular biological (PCR, ddPCR) methods, immunological methods (ELISA, MSD), spectroscopic and fluorescent methods, flow cytometry, HPLC, automated liquid handling, electronic notebooks. Prior experience leading a team in Analytical method development, testing, QC, or stability is important for success in the position. Must have exceptional organizational skills, preferably with advanced practical experience (+/-certification) in operational excellence or the management of complex workflows using Lean or Six Sigma. Solid understanding of relevant regulatory agency guidance such as FDA, ICH and EMA and hand-on experience. Ability to work in a fast-paced growth environment, and to prioritize work from multiple projects. Demonstrates a respect for others and is open to new/different ideas. Excellent written and verbal communication skills. Preferred Qualifications Bachelors plus 15 yrs or equivalent combination of education and work experience; expert knowledge of principals and concepts and is a thought leader; has experience managing department(s) with senior employees. Organizational leader with experience managing a team of direct (and indirect) reports in technical development of CMC (analytical, process, or formulation) packages for IND/CTA submission. Demonstrated track record, broad experience, and demonstrated success in analytical sciences for characterization of biological products, associated product-related species, and process residuals/impurities.
JOB PURPOSE Sana Biotechnology is looking to expand our team with hard-working individuals who believe in the potential of cells as engineered medicines, have the vision to do creative things, and the determination to execute that vision. The Protein Engineering Senior Research Associate will be responsible for the testing of proteins and DNA vectors that support our novel targeted gene therapy platform. Characterization of therapeutic candidates, alongside in vitro assay development will be key elements of the position. This individual will join a dynamic, rapidly growing, and highly collaborative team that combines significant biologic drug discovery experience with pioneering discoveries driving multiple biological platforms. DUTIES AND RESPONSIBILITIES Testing of novel constructs for mammalian cell transduction via flow cytometry and imaging techniques Assay development for testing novel protein vectors that support our platform technology Characterization of gene expression and cell-identity markers in mammalian cells using flow cytometry, microscopy, qPCR, ELISA, etc. Mammalian cell culture and transformation Following Standard Operating Procedures and developing new protocols when necessary Working collaboratively to generate and screen novel therapeutics Maintenance of detailed electronic lab notebook and registration of constructs and biologics QUALIFICATIONS Basic Qualifications Bachelors Degree plus 3+ years laboratory experience in an academic or industry setting, or Masters Degree in related field (Biology, Biochemistry, Engineering) with at least 1+ years with laboratory experience in an academic or industry setting. Well versed in a wide array of laboratory techniques and experienced in their use. Experienced with interpersonal skills and an ability to adapt communication style to interact effectively with collaborators. Attention to detail and data quality, and experience working on collaborative teams. Preferred Qualifications Demonstrated ability in working in a fast-paced, collaborative, and technical environment. Excellent bench skills with attention to detail for data integrity and quality. Understanding of mammalian molecular biology and cell biology. Excellent communication and presentation skills, capable of conveying technical information in a clear and thorough manner. PHYSICAL REQUIREMENTS Carrying, handling and reaching for objects up to 25 lbs Prolonged standing and/or sitting Exposure to hazardous/toxic/dangerous chemicals Manual dexterity required to operate office and lab equipment
01/19/2021
Full time
JOB PURPOSE Sana Biotechnology is looking to expand our team with hard-working individuals who believe in the potential of cells as engineered medicines, have the vision to do creative things, and the determination to execute that vision. The Protein Engineering Senior Research Associate will be responsible for the testing of proteins and DNA vectors that support our novel targeted gene therapy platform. Characterization of therapeutic candidates, alongside in vitro assay development will be key elements of the position. This individual will join a dynamic, rapidly growing, and highly collaborative team that combines significant biologic drug discovery experience with pioneering discoveries driving multiple biological platforms. DUTIES AND RESPONSIBILITIES Testing of novel constructs for mammalian cell transduction via flow cytometry and imaging techniques Assay development for testing novel protein vectors that support our platform technology Characterization of gene expression and cell-identity markers in mammalian cells using flow cytometry, microscopy, qPCR, ELISA, etc. Mammalian cell culture and transformation Following Standard Operating Procedures and developing new protocols when necessary Working collaboratively to generate and screen novel therapeutics Maintenance of detailed electronic lab notebook and registration of constructs and biologics QUALIFICATIONS Basic Qualifications Bachelors Degree plus 3+ years laboratory experience in an academic or industry setting, or Masters Degree in related field (Biology, Biochemistry, Engineering) with at least 1+ years with laboratory experience in an academic or industry setting. Well versed in a wide array of laboratory techniques and experienced in their use. Experienced with interpersonal skills and an ability to adapt communication style to interact effectively with collaborators. Attention to detail and data quality, and experience working on collaborative teams. Preferred Qualifications Demonstrated ability in working in a fast-paced, collaborative, and technical environment. Excellent bench skills with attention to detail for data integrity and quality. Understanding of mammalian molecular biology and cell biology. Excellent communication and presentation skills, capable of conveying technical information in a clear and thorough manner. PHYSICAL REQUIREMENTS Carrying, handling and reaching for objects up to 25 lbs Prolonged standing and/or sitting Exposure to hazardous/toxic/dangerous chemicals Manual dexterity required to operate office and lab equipment
JOB PURPOSE This position will report directly to a scientist in the In Vivo Pharmacology group within the department of Pharmacology and Toxicology. The Senior Research Associate (SRA) will have three primary responsibilities: (1) to execute in vivo studies to support gene therapy and cell therapy research programs at Sana, via close collaboration with other members of the IVP team, (2) to carry out cell and tissue preparation work related to in vivo studies, and (3) to support needs across the Pharmacology and Toxicology organization. The position will also require close communication and collaboration with research groups at Sana outside of the Pharmacology and Toxicology organization. DUTIES AND RESPONSIBILITIES Work closely with the Scientist and current in vivo coordinator to plan and execute in vivo studies in support of cross-functional groups Tissue collection and processing for downstream assays such as flow cytometry Support in vitro work (e.g. cell culture) to enable in vivo studies Due diligence on data recording, analysis and reporting using proper software (e.g.Graphpad Prism, Softmouse, FlowJo), electronic notebook, and data storage room Presentation of data to the team Participate in creating a collaborative, rewarding work environment QUALIFICATIONS Required Qualifications BS in biology or related discipline with 4+ years/MS with industry/academic experience Proficiency with standard molecular biology and cell biology techniques: RNA isolation and reverse-transcription, qPCR, mammalian cell culture, staining for Flow Cytometry and Lentivirus transduction Demonstrated experience with relevant software: Microsoft Word, Excel, PowerPoint, Graphpad Prism, FlowJo software Experience in developing in vitro and in vivo assays and deploying at scale in a collaborative research environment Extensive hands-on experience with the isolation and culture of mammalian cell lines and primary cells Demonstrated competence in sterile cell culture technique Proven ability to troubleshoot technical and scientific issues Strong interpersonal skills and adaptable communication style Strong organizational, record keeping, and data documentation skills Excellent oral and written communication skills, attention to detail and data quality, and experience working on diverse collaborative teams Willingness to work under adverse situation (e.g. COVID 19) Preferred Qualifications BS or MS degree in immunology Experience with immune cell profiling using flow cytometry techniques Experience in working with mice: handling, injections (IV, IP, SC), bleeding, tissue harvest
01/15/2021
Full time
JOB PURPOSE This position will report directly to a scientist in the In Vivo Pharmacology group within the department of Pharmacology and Toxicology. The Senior Research Associate (SRA) will have three primary responsibilities: (1) to execute in vivo studies to support gene therapy and cell therapy research programs at Sana, via close collaboration with other members of the IVP team, (2) to carry out cell and tissue preparation work related to in vivo studies, and (3) to support needs across the Pharmacology and Toxicology organization. The position will also require close communication and collaboration with research groups at Sana outside of the Pharmacology and Toxicology organization. DUTIES AND RESPONSIBILITIES Work closely with the Scientist and current in vivo coordinator to plan and execute in vivo studies in support of cross-functional groups Tissue collection and processing for downstream assays such as flow cytometry Support in vitro work (e.g. cell culture) to enable in vivo studies Due diligence on data recording, analysis and reporting using proper software (e.g.Graphpad Prism, Softmouse, FlowJo), electronic notebook, and data storage room Presentation of data to the team Participate in creating a collaborative, rewarding work environment QUALIFICATIONS Required Qualifications BS in biology or related discipline with 4+ years/MS with industry/academic experience Proficiency with standard molecular biology and cell biology techniques: RNA isolation and reverse-transcription, qPCR, mammalian cell culture, staining for Flow Cytometry and Lentivirus transduction Demonstrated experience with relevant software: Microsoft Word, Excel, PowerPoint, Graphpad Prism, FlowJo software Experience in developing in vitro and in vivo assays and deploying at scale in a collaborative research environment Extensive hands-on experience with the isolation and culture of mammalian cell lines and primary cells Demonstrated competence in sterile cell culture technique Proven ability to troubleshoot technical and scientific issues Strong interpersonal skills and adaptable communication style Strong organizational, record keeping, and data documentation skills Excellent oral and written communication skills, attention to detail and data quality, and experience working on diverse collaborative teams Willingness to work under adverse situation (e.g. COVID 19) Preferred Qualifications BS or MS degree in immunology Experience with immune cell profiling using flow cytometry techniques Experience in working with mice: handling, injections (IV, IP, SC), bleeding, tissue harvest