Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our pipeline includes pneumococcal conjugate vaccine, or PCV, candidates that we believe are the most broad-spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate PCV with preclinical proof-of- concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of strain coverage, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds. Summary: Vaxcyte is looking for an energetic and talented individual to join the Formulation and Drug Product Development team. The primary responsibility for the incumbent will be to support the late stage activities of the Drug Product (DP) team in readiness for phase 3 clinical studies and through commercial launch. Due to the number of antigens and the suspended adjuvant system, this is arguably one of the most complex Drug Products in clinical development, so it is an incredible opportunity for the right candidate to make a significant impact on the product, the company, and the industry. This is a senior position and will require the candidate to have a high level of independence, scientific judgement, and leadership abilities. Essential Activities: • Evaluate, select, and oversee an appropriate fill finish CMO service provider to support early, late, and commercial stage manufacturing deliverables • In concert with the CMC team, design and oversee late-stage process characterization and process validation strategies consistent with CMC-regulatory guidance • Provide engineering leadership to generate the appropriate solutions for successful commercial mixing of the DP intermediates that allows compounding of 24 Drug Substances (DS) • Generation, testing, and validation of scalable mixing solutions of the DP bulk suspension mixture to ensure adequate homogeneity during the DP final fill. • Downscale of the above engineering solutions, where appropriate and possible, for utilization and facilitation of internal development work • Facilitate cross-functional process risk analysis using appropriate tools such as FMEA, leading to the identification of CPPs and CQAs • Establish supply chain logistics for the shipping of DS/intermediates/DP bulk under liquid or frozen conditions with suitable container closure systems Requirements: • BSc or MSc in Chemical Engineering, Process Engineering, Pharmaceutical Development preferred, with >15 year of industrial experience; or PhD with >10 years. • Experience in late-stage clinical manufacturing within fill finish sites under GMP regulations; it is mandatory that the successful candidate be entirely conversant with GMP manufacturing • Direct experience of chemical engineering in the biological manufacturing space, leading to custom engineering solutions • Experience in the progression of such engineering solutions from early to late clinical stage and through commercial launch, preferably in the fill/finish arena • Experience in the development of scaleup/down models and how they pertain to mixing of DP bulk, preferably suspension systems • Experience in validation of DP processes, including the use of QbD as required • Experience in leading the evaluation, selection and oversight of CMOs that perform DP fill finish activities • An understanding of the design and management of logistical supply chains to enable bespoke fill finish activities • Strong interpersonal and leadership skills; ability to communicate effectively both verbally and in written formats • Ability to work within in a fast-paced, cross functional environment, multitasking as needed Reports to: Director of Formulation and Drug Product Development Location: Foster City, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
03/05/2021
Full time
Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our pipeline includes pneumococcal conjugate vaccine, or PCV, candidates that we believe are the most broad-spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate PCV with preclinical proof-of- concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of strain coverage, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds. Summary: Vaxcyte is looking for an energetic and talented individual to join the Formulation and Drug Product Development team. The primary responsibility for the incumbent will be to support the late stage activities of the Drug Product (DP) team in readiness for phase 3 clinical studies and through commercial launch. Due to the number of antigens and the suspended adjuvant system, this is arguably one of the most complex Drug Products in clinical development, so it is an incredible opportunity for the right candidate to make a significant impact on the product, the company, and the industry. This is a senior position and will require the candidate to have a high level of independence, scientific judgement, and leadership abilities. Essential Activities: • Evaluate, select, and oversee an appropriate fill finish CMO service provider to support early, late, and commercial stage manufacturing deliverables • In concert with the CMC team, design and oversee late-stage process characterization and process validation strategies consistent with CMC-regulatory guidance • Provide engineering leadership to generate the appropriate solutions for successful commercial mixing of the DP intermediates that allows compounding of 24 Drug Substances (DS) • Generation, testing, and validation of scalable mixing solutions of the DP bulk suspension mixture to ensure adequate homogeneity during the DP final fill. • Downscale of the above engineering solutions, where appropriate and possible, for utilization and facilitation of internal development work • Facilitate cross-functional process risk analysis using appropriate tools such as FMEA, leading to the identification of CPPs and CQAs • Establish supply chain logistics for the shipping of DS/intermediates/DP bulk under liquid or frozen conditions with suitable container closure systems Requirements: • BSc or MSc in Chemical Engineering, Process Engineering, Pharmaceutical Development preferred, with >15 year of industrial experience; or PhD with >10 years. • Experience in late-stage clinical manufacturing within fill finish sites under GMP regulations; it is mandatory that the successful candidate be entirely conversant with GMP manufacturing • Direct experience of chemical engineering in the biological manufacturing space, leading to custom engineering solutions • Experience in the progression of such engineering solutions from early to late clinical stage and through commercial launch, preferably in the fill/finish arena • Experience in the development of scaleup/down models and how they pertain to mixing of DP bulk, preferably suspension systems • Experience in validation of DP processes, including the use of QbD as required • Experience in leading the evaluation, selection and oversight of CMOs that perform DP fill finish activities • An understanding of the design and management of logistical supply chains to enable bespoke fill finish activities • Strong interpersonal and leadership skills; ability to communicate effectively both verbally and in written formats • Ability to work within in a fast-paced, cross functional environment, multitasking as needed Reports to: Director of Formulation and Drug Product Development Location: Foster City, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our pipeline includes pneumococcal conjugate vaccine, or PCV, candidates that we believe are the most broad-spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate PCV with preclinical proof-of- concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 30 strains, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds. Summary: The Development organization is comprised of four Process teams: Protein, Polysaccharide, Conjugate Drug Substance, and Drug Product. These Process Development teams are supported by Analytical Development and Formulation Development teams. Vaxcyte is looking for a Director / Senior Director to lead the Protein Development team. Essential Functions: • Manage group of four (two PhD-level scientists, and two associates); grow group to ~10 FTEs over the next 3-5 years • Flesh out nascent Phase 3 / commercial plan for proprietary eCRM carrier protein • In coordination with CMO, devise and oversee late-stage process characterization and process validation strategies consistent with CMC-regulatory guidance • Solidify complex cell-free reagent supply chain (comprised of proprietary cell extracts and lysates, a complex small molecule, and plasmid DNA) • Lead the development of the upstream (cell-free) and downstream processes for pipeline vaccine-based proteins (transferred from Research team) • Provide engineering expertise and leadership, ensuring developed processes are scalable, economic, and appropriately transferred to CMO • Ensure all CMO oversight responsibilities for proteins are carried out in a manner compliant with internal Vaxcyte SOPs • Be a key member of the CMC senior leadership team, which is charged with establishing CMC strategic direction and decisions • Establish timelines and manage budget for Protein Development functional area • Be an outstanding teammate Requirements: • PhD in Chemical Engineering or Chemistry/Biochemistry with 10+ years of relevant Pharma/Biotech industry experience, or MS in Chemical Engineering or Chemistry/ Biochemistry with 15+ years of relevant Pharma/Biotech industry experience • Proven leadership skills • Outstanding organization and planning skills • Clear and compelling (written and oral) communication skills • Phenomenal team skills; demonstrated ability to work exceedingly well in a multi- disciplinary team structure • Ability to work in small company environment; (Vaxcyte has ~50 full-time employees) • Experience bringing a protein (or protein-based) product to market • Experience partnering with CMOs; Vaxcyte has contracted Lonza (Visp, Switzerland) to manufacture our proprietary eCRM carrier protein • Broad experience authoring IND and BLA Module 3 sections • GMP knowledge and experience, preferably as it applies to both manufacturing and QC • Exceptionally strong from a technical / scientific perspective - In-depth knowledge of downstream unit operations (chromatography, TFF, etc.) - Experience with cell-free upstream technology a plus but not required - Expert in Design of Experiments (DoE) - Strong analytical method skills Reports to: SVP, Process and Analytical Development Location: Foster City, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
01/31/2021
Full time
Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our pipeline includes pneumococcal conjugate vaccine, or PCV, candidates that we believe are the most broad-spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate PCV with preclinical proof-of- concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 30 strains, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds. Summary: The Development organization is comprised of four Process teams: Protein, Polysaccharide, Conjugate Drug Substance, and Drug Product. These Process Development teams are supported by Analytical Development and Formulation Development teams. Vaxcyte is looking for a Director / Senior Director to lead the Protein Development team. Essential Functions: • Manage group of four (two PhD-level scientists, and two associates); grow group to ~10 FTEs over the next 3-5 years • Flesh out nascent Phase 3 / commercial plan for proprietary eCRM carrier protein • In coordination with CMO, devise and oversee late-stage process characterization and process validation strategies consistent with CMC-regulatory guidance • Solidify complex cell-free reagent supply chain (comprised of proprietary cell extracts and lysates, a complex small molecule, and plasmid DNA) • Lead the development of the upstream (cell-free) and downstream processes for pipeline vaccine-based proteins (transferred from Research team) • Provide engineering expertise and leadership, ensuring developed processes are scalable, economic, and appropriately transferred to CMO • Ensure all CMO oversight responsibilities for proteins are carried out in a manner compliant with internal Vaxcyte SOPs • Be a key member of the CMC senior leadership team, which is charged with establishing CMC strategic direction and decisions • Establish timelines and manage budget for Protein Development functional area • Be an outstanding teammate Requirements: • PhD in Chemical Engineering or Chemistry/Biochemistry with 10+ years of relevant Pharma/Biotech industry experience, or MS in Chemical Engineering or Chemistry/ Biochemistry with 15+ years of relevant Pharma/Biotech industry experience • Proven leadership skills • Outstanding organization and planning skills • Clear and compelling (written and oral) communication skills • Phenomenal team skills; demonstrated ability to work exceedingly well in a multi- disciplinary team structure • Ability to work in small company environment; (Vaxcyte has ~50 full-time employees) • Experience bringing a protein (or protein-based) product to market • Experience partnering with CMOs; Vaxcyte has contracted Lonza (Visp, Switzerland) to manufacture our proprietary eCRM carrier protein • Broad experience authoring IND and BLA Module 3 sections • GMP knowledge and experience, preferably as it applies to both manufacturing and QC • Exceptionally strong from a technical / scientific perspective - In-depth knowledge of downstream unit operations (chromatography, TFF, etc.) - Experience with cell-free upstream technology a plus but not required - Expert in Design of Experiments (DoE) - Strong analytical method skills Reports to: SVP, Process and Analytical Development Location: Foster City, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our pipeline includes pneumococcal conjugate vaccine, or PCV, candidate s that we believe are the most broad-spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate PCV with preclinical proof-of- concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 30 strains, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds. Summary: We are looking for a Senior Engineer with late-stage clinical or commercial experience in manufacturing, process characterization, and process validation of biologics. The successful candidate must have the ability to work in a highly collaborative manner with both internal teams and our CMO. We are looking for an outstanding team player with excellent communication skills. The Senior Engineer will work collaboratively with the process development team responsible for early-stage bioconjugation development and Phase 1 process optimization. The Senior Engineer will be directly responsible for defining an inventive process characterization strategy for a multivalent vaccine program, and will play a critical role in overseeing process validation and implementation of a process control strategy at the commercial facility to support BLA filing and commercial launch. The candidate should have demonstrated experience with risk assessments, FMEA and identifying critical and non-critical performance parameters. Depending on experience, involvement in the design or selection of a commercial launch facility with the CMC and PD leadership is likely. This is a great opportunity to make an impact and interact cross-functionally to take Vaxcyte's lead program to the next level toward the company's first licensure application. Essential Functions: • Perform and facilitate completion of process design and characterization deliverables required for commercial manufacture of multiple drug substances. • Contribute to assessing internal or external options to complete Process Characterization and validation in a timely manner with an economy of resources and materials. • Support late stage process validation activities (including PPQ) at CMO(s) or Vaxcyte owned facility. • Facilitate and lead process risk assessments to drive process control strategies and help prioritize characterization experiments. • Independently or cooperatively design and execute studies supporting process characterization and validation. • Write and contribute to process characterization, scale-up, process control and process validation documents including strategy documents, test plans and protocols, control and process descriptions, plan summaries, SOPs. Contribute to authoring related sections to support regulatory filings. • Work with internal Process Development, Analytical Development and CMC and QA leadership and CMO's process development and GMP manufacturing team members to ensure a robust, scalable production process. Requirements: • PhD or MS degree in biochemical, chemical, or biomedical engineering with 6-8 years of relevant experience. Bachelor's degree with appreciable experience (8-12 years) will be considered as well. • Working knowledge of US FDA CFRs and European EMA, including ICH regulations • In-depth knowledge of equipment, operations, and engineering principles involved in biologics GMP manufacturing • Must have strong engineering, statistical, or scientific knowledge appropriate for job requirements. Experience with risk assessment exercises, FMEA or RAMM is required. • Experience in protein downstream purification. • Experience with Tangential Flow Filtration development is highly desirable. • Experience with manufacturing of bioconjugates (ADCs, protein conjugates, glycoconjugates, nanoparticles) is highly desirable. • Ability to understand and keep track of regulatory expectations and industry best practices. • Process control strategy, tech transfer and process validation experience. • Ability to think outside the box and combine thoroughness and inventive approaches to complex process characterization using DoE and aspects of QbD. • Experience with biologics commercial launch highly desirable. • Excellent verbal and written communication skills. • Must have excellent organization skills and the ability to handle multiple tasks. • Highly motivated, and willingness to acquire new skills and ability to work independently as well as collaboratively in a matrix environment. • Ability to travel internationally is required (not more than an average of once per quarter) Reports to: Director, Bioconjugates Development and Manufacturing Location: Foster City, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
01/27/2021
Full time
Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our pipeline includes pneumococcal conjugate vaccine, or PCV, candidate s that we believe are the most broad-spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate PCV with preclinical proof-of- concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 30 strains, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds. Summary: We are looking for a Senior Engineer with late-stage clinical or commercial experience in manufacturing, process characterization, and process validation of biologics. The successful candidate must have the ability to work in a highly collaborative manner with both internal teams and our CMO. We are looking for an outstanding team player with excellent communication skills. The Senior Engineer will work collaboratively with the process development team responsible for early-stage bioconjugation development and Phase 1 process optimization. The Senior Engineer will be directly responsible for defining an inventive process characterization strategy for a multivalent vaccine program, and will play a critical role in overseeing process validation and implementation of a process control strategy at the commercial facility to support BLA filing and commercial launch. The candidate should have demonstrated experience with risk assessments, FMEA and identifying critical and non-critical performance parameters. Depending on experience, involvement in the design or selection of a commercial launch facility with the CMC and PD leadership is likely. This is a great opportunity to make an impact and interact cross-functionally to take Vaxcyte's lead program to the next level toward the company's first licensure application. Essential Functions: • Perform and facilitate completion of process design and characterization deliverables required for commercial manufacture of multiple drug substances. • Contribute to assessing internal or external options to complete Process Characterization and validation in a timely manner with an economy of resources and materials. • Support late stage process validation activities (including PPQ) at CMO(s) or Vaxcyte owned facility. • Facilitate and lead process risk assessments to drive process control strategies and help prioritize characterization experiments. • Independently or cooperatively design and execute studies supporting process characterization and validation. • Write and contribute to process characterization, scale-up, process control and process validation documents including strategy documents, test plans and protocols, control and process descriptions, plan summaries, SOPs. Contribute to authoring related sections to support regulatory filings. • Work with internal Process Development, Analytical Development and CMC and QA leadership and CMO's process development and GMP manufacturing team members to ensure a robust, scalable production process. Requirements: • PhD or MS degree in biochemical, chemical, or biomedical engineering with 6-8 years of relevant experience. Bachelor's degree with appreciable experience (8-12 years) will be considered as well. • Working knowledge of US FDA CFRs and European EMA, including ICH regulations • In-depth knowledge of equipment, operations, and engineering principles involved in biologics GMP manufacturing • Must have strong engineering, statistical, or scientific knowledge appropriate for job requirements. Experience with risk assessment exercises, FMEA or RAMM is required. • Experience in protein downstream purification. • Experience with Tangential Flow Filtration development is highly desirable. • Experience with manufacturing of bioconjugates (ADCs, protein conjugates, glycoconjugates, nanoparticles) is highly desirable. • Ability to understand and keep track of regulatory expectations and industry best practices. • Process control strategy, tech transfer and process validation experience. • Ability to think outside the box and combine thoroughness and inventive approaches to complex process characterization using DoE and aspects of QbD. • Experience with biologics commercial launch highly desirable. • Excellent verbal and written communication skills. • Must have excellent organization skills and the ability to handle multiple tasks. • Highly motivated, and willingness to acquire new skills and ability to work independently as well as collaboratively in a matrix environment. • Ability to travel internationally is required (not more than an average of once per quarter) Reports to: Director, Bioconjugates Development and Manufacturing Location: Foster City, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our pipeline includes pneumococcal conjugate vaccine, or PCV, candidates that we believe are the most broad- spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate PCV with preclinical proof-of-concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX- XP, a PCV with an expanded breadth of coverage of at least 30 strains, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds. Summary: Vaxcyte is looking for an energetic and talented individual to join our Formulation and Drug Product Development team. Candidate should be an experienced and flexible individual who would be comfortable working on multiple tasks at once, with excellent communication skills to navigate rapid changes in prioritization. This position is for a scientific role which will be primarily lab based. The candidate will have a good knowledge and practical experience in the field of vaccine formulation. The candidate will also have industry based experience in a range of standard protein biochemistry analytical techniques. Experience in biophysical characterization of formulations would be very beneficial. The primary responsibility for the incumbent will be to support development of projects from the research through the preclinical phase, into early clinical phases and also supporting later stage programs. Essential Functions: • Supporting formulation manufacture for thermal, freeze/thaw, and agitation stability studies on both Drug Substance (DS) and Drug Product (DP) materials • Conducting analysis of these formulations using a broad range of standard protein biochemistry analytical techniques for formulation selection • Supporting formulation comparability studies, container selection and scale up activities • Preparing sterile formulation samples to be used for in vivo testing • Evaluating effect of new formulation components on already established standard analytical assays • Maintaining an accurate and up to date inventory of supplies of DS used by multiple groups Requirements: • BSc or MSc in Pharmaceutics, Chemistry, Biophysics or Biochemistry preferred, or Analytical Chemistry or Biology considered, with >2years of industrial experience • The candidate will have had previous experience in developing formulation of proteins, polysaccharides and/or protein conjugates for adjuvant containing vaccines (other biological experience also considered) • Experience supporting stability studies, including study set up and sample testing and analysis • Experience in using standard protein plate based assays is needed. Some experience in spectrometric methodologies, particle light scattering, quantitative subvisible particle analysis, visible analysis and HPLC/UV is preferred • Experience working under aseptic conditions is necessary • Strong interpersonal skills; ability to communicate effectively both verbally and in written formats (must be able to work with managerial and lab team in remote setting when needed) are necessary to collaborate effectively with the rest of the Formulation and Drug Product Development team • Critical thinking, the ability to analyse data and to report results to the team in a clear and concise manner during group meetings is needed • Eagerness, ability to learn and great flexibility to rapidly switch gears between tasks • Detail oriented, rigorous and excellent skills in record keeping/documentation • Good proficiency in the use of Microsoft office suite (in particular Excel and PowerPoint) Reports to: Senior Scientist in the Formulation and Drug Product Development team Location: Foster City, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
01/27/2021
Full time
Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our pipeline includes pneumococcal conjugate vaccine, or PCV, candidates that we believe are the most broad- spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate PCV with preclinical proof-of-concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX- XP, a PCV with an expanded breadth of coverage of at least 30 strains, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds. Summary: Vaxcyte is looking for an energetic and talented individual to join our Formulation and Drug Product Development team. Candidate should be an experienced and flexible individual who would be comfortable working on multiple tasks at once, with excellent communication skills to navigate rapid changes in prioritization. This position is for a scientific role which will be primarily lab based. The candidate will have a good knowledge and practical experience in the field of vaccine formulation. The candidate will also have industry based experience in a range of standard protein biochemistry analytical techniques. Experience in biophysical characterization of formulations would be very beneficial. The primary responsibility for the incumbent will be to support development of projects from the research through the preclinical phase, into early clinical phases and also supporting later stage programs. Essential Functions: • Supporting formulation manufacture for thermal, freeze/thaw, and agitation stability studies on both Drug Substance (DS) and Drug Product (DP) materials • Conducting analysis of these formulations using a broad range of standard protein biochemistry analytical techniques for formulation selection • Supporting formulation comparability studies, container selection and scale up activities • Preparing sterile formulation samples to be used for in vivo testing • Evaluating effect of new formulation components on already established standard analytical assays • Maintaining an accurate and up to date inventory of supplies of DS used by multiple groups Requirements: • BSc or MSc in Pharmaceutics, Chemistry, Biophysics or Biochemistry preferred, or Analytical Chemistry or Biology considered, with >2years of industrial experience • The candidate will have had previous experience in developing formulation of proteins, polysaccharides and/or protein conjugates for adjuvant containing vaccines (other biological experience also considered) • Experience supporting stability studies, including study set up and sample testing and analysis • Experience in using standard protein plate based assays is needed. Some experience in spectrometric methodologies, particle light scattering, quantitative subvisible particle analysis, visible analysis and HPLC/UV is preferred • Experience working under aseptic conditions is necessary • Strong interpersonal skills; ability to communicate effectively both verbally and in written formats (must be able to work with managerial and lab team in remote setting when needed) are necessary to collaborate effectively with the rest of the Formulation and Drug Product Development team • Critical thinking, the ability to analyse data and to report results to the team in a clear and concise manner during group meetings is needed • Eagerness, ability to learn and great flexibility to rapidly switch gears between tasks • Detail oriented, rigorous and excellent skills in record keeping/documentation • Good proficiency in the use of Microsoft office suite (in particular Excel and PowerPoint) Reports to: Senior Scientist in the Formulation and Drug Product Development team Location: Foster City, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our pipeline includes pneumococcal conjugate vaccine, or PCV, candidate s that we believe are the most broad-spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate PCV with preclinical proof-of- concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 30 strains, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds. Summary: Vaxcyte is looking for an energetic, highly skilled and talented individual to join Vaxcyte's Vaccine Product Development organization as an Associate Director/Director within Analytical Development Quality Control department. The primary function of this Director level position in to lead the development and optimization of bioassays for the lot release, characterization, and stability and formulation assessment of conjugate vaccine intermediates, and drug substance and drug product in preclinical and clinical development. The successful candidate will also manage and build a growing group of scientists and research associates and oversee work performed in CROs. Essential Functions: • Take on end- to-end strategic responsibility for bioassay method development of intermediates, drug substance and drug products. • Lead a team of 4-5 scientists and research associate to develop, optimize, and qualify phase-appropriate a broad spectrum of immunoassay for release, stability, and formulation optimization • Drive analytical innovation and stay on top of cutting edge bioassay technology, apply innovative approaches to problem solving, and introduce and establish novel technology in house if necessary. • Collaborate with CROs to develop antibody critical reagents for the immunoassay development • Provide technical tactics and oversight of antibody purification to optimize the immunoassay performance • Develop and implement critical reagent qualification plans • Manage scientists of various levels, provide technical direction, mentorship and coaching • Cultivate a cohesive, innovative, nimble and productive team environment • Support Associate Director of QC for GMP analytical method transfer and validation at the CMOs, as well as trouble shooting of QC testing or method related issue • Collaborate with Formulation and Conjugation team to design and develop phase appropriate bioassay for in-process control and GMP quality control purpose. • Author SOPs, technical reports and multiple regulatory submission when needed, and address health authority questions during various clinical phase filings • Serves as a scientific liaison for outsourced assay development, technology transfer and data management in a CRO or CMO/CDMO environment • Evaluate and establish contracts with CDMO/CROs for method development and GMP testing or stability studies • Manage relationships with CDMOs, including managing timelines and cost for the analytical method and GMP testing. • Provide appropriate CRO/CDMO oversight by reviewing analytical method development data, reviewing and approving analytical method development report, method validation protocols, reports, and analytical method SOPs Requirements: • PhD in Biochemistry, Analytical Chemistry or Cell Biology, with 10+ years relevant industry experience; MS or BS with 15+ years of industry experience in Pharma/Diagnostic industry required • Must be a team player, strong critical thinker, exhibit a willingness to meet project timelines and multitask effectively in a dynamic fast-paced environment under challenging timelines • Proven track record of heading bioassay development for biologics, leading teams while managing multiple projects, experience building team and lab is highly desirable • A strong scientific leader who can independently design, execute, and guide effective experiments with clear goals of developing robust germane bioassay methods. and effectively and skilfully troubleshoot bioassay issue during method development, transfer, validation and QC testing in a fast pace environment • A proven track record of solving complex immunoassay and bioanalytical problems • Experiences in hybridoma technology including optimizing the immunization and fusion process, assay development, lead antibody selection and characterization. • Efficient in Interpreting data and communicating project status or risk mitigation strategies that drive critical decisions in CMC cross functional team • Demonstrated leadership and track record of successfully developing different format of bioassays by utilizing appropriate methodologies • Thorough understanding and hands on experience of MSD platform is highly desirable • Fundamental understanding of key immunology concepts related to assessment of vaccine- induced responses required • Solid understanding of relevant FDA, EU, and ICH regulatory guidelines an d pharmacopeia as applicable to immunoassay method qualification/validation for biologics and vaccines, and demonstrated ability of applying the regulatory guidance to formulate practical solutions and phase appropriate analytical strategy • Experience in IND, NDA and BLA submission is preferred • Project management skills including the ability to manage project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management • Fundamental understanding of statistics and data analysis software, proficient with analytical software such as Softmax Pro and familiar with statistical software such as JMP • Strong interpersonal skills; ability to communicate effectively both verbally and in written formats • Strong attention to detail supported by excellent time management and organizational skills Reports to: Senior Director, Analytical Development & Quality Control Location: Foster City, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
01/26/2021
Full time
Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our pipeline includes pneumococcal conjugate vaccine, or PCV, candidate s that we believe are the most broad-spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate PCV with preclinical proof-of- concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of coverage of at least 30 strains, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds. Summary: Vaxcyte is looking for an energetic, highly skilled and talented individual to join Vaxcyte's Vaccine Product Development organization as an Associate Director/Director within Analytical Development Quality Control department. The primary function of this Director level position in to lead the development and optimization of bioassays for the lot release, characterization, and stability and formulation assessment of conjugate vaccine intermediates, and drug substance and drug product in preclinical and clinical development. The successful candidate will also manage and build a growing group of scientists and research associates and oversee work performed in CROs. Essential Functions: • Take on end- to-end strategic responsibility for bioassay method development of intermediates, drug substance and drug products. • Lead a team of 4-5 scientists and research associate to develop, optimize, and qualify phase-appropriate a broad spectrum of immunoassay for release, stability, and formulation optimization • Drive analytical innovation and stay on top of cutting edge bioassay technology, apply innovative approaches to problem solving, and introduce and establish novel technology in house if necessary. • Collaborate with CROs to develop antibody critical reagents for the immunoassay development • Provide technical tactics and oversight of antibody purification to optimize the immunoassay performance • Develop and implement critical reagent qualification plans • Manage scientists of various levels, provide technical direction, mentorship and coaching • Cultivate a cohesive, innovative, nimble and productive team environment • Support Associate Director of QC for GMP analytical method transfer and validation at the CMOs, as well as trouble shooting of QC testing or method related issue • Collaborate with Formulation and Conjugation team to design and develop phase appropriate bioassay for in-process control and GMP quality control purpose. • Author SOPs, technical reports and multiple regulatory submission when needed, and address health authority questions during various clinical phase filings • Serves as a scientific liaison for outsourced assay development, technology transfer and data management in a CRO or CMO/CDMO environment • Evaluate and establish contracts with CDMO/CROs for method development and GMP testing or stability studies • Manage relationships with CDMOs, including managing timelines and cost for the analytical method and GMP testing. • Provide appropriate CRO/CDMO oversight by reviewing analytical method development data, reviewing and approving analytical method development report, method validation protocols, reports, and analytical method SOPs Requirements: • PhD in Biochemistry, Analytical Chemistry or Cell Biology, with 10+ years relevant industry experience; MS or BS with 15+ years of industry experience in Pharma/Diagnostic industry required • Must be a team player, strong critical thinker, exhibit a willingness to meet project timelines and multitask effectively in a dynamic fast-paced environment under challenging timelines • Proven track record of heading bioassay development for biologics, leading teams while managing multiple projects, experience building team and lab is highly desirable • A strong scientific leader who can independently design, execute, and guide effective experiments with clear goals of developing robust germane bioassay methods. and effectively and skilfully troubleshoot bioassay issue during method development, transfer, validation and QC testing in a fast pace environment • A proven track record of solving complex immunoassay and bioanalytical problems • Experiences in hybridoma technology including optimizing the immunization and fusion process, assay development, lead antibody selection and characterization. • Efficient in Interpreting data and communicating project status or risk mitigation strategies that drive critical decisions in CMC cross functional team • Demonstrated leadership and track record of successfully developing different format of bioassays by utilizing appropriate methodologies • Thorough understanding and hands on experience of MSD platform is highly desirable • Fundamental understanding of key immunology concepts related to assessment of vaccine- induced responses required • Solid understanding of relevant FDA, EU, and ICH regulatory guidelines an d pharmacopeia as applicable to immunoassay method qualification/validation for biologics and vaccines, and demonstrated ability of applying the regulatory guidance to formulate practical solutions and phase appropriate analytical strategy • Experience in IND, NDA and BLA submission is preferred • Project management skills including the ability to manage project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management • Fundamental understanding of statistics and data analysis software, proficient with analytical software such as Softmax Pro and familiar with statistical software such as JMP • Strong interpersonal skills; ability to communicate effectively both verbally and in written formats • Strong attention to detail supported by excellent time management and organizational skills Reports to: Senior Director, Analytical Development & Quality Control Location: Foster City, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
Vaxcyte, Inc. (Nasdaq: PCVX) is a next - generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell - free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our pipeline includes pneumococcal conjugate vaccine, or PCV, candidates that w e believe are the most broad - spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX - 24, is a preclinical, 24 - valent broad - spectrum pneumococcal conjugate PCV with precl inical proof -of- concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX - XP, a PCV with an expanded breadth of coverage of at least 30 strains, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; VAX - A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX - PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds. Summary: Vaxcyte is looking for an energetic and talented individual to join Vaxcyte 's Vac cine Product Development organization as a Director within Analytical Development and QC (ADQC) . The primary function of t his director level position is to oversee the QC activities and compliance such as analytical method transfer to the CMO, the method validation and release and stability testing. The person will also be the functional decision maker for QC, stability and reference standard program strategic decision s, and serve as a key contributor for company long term growth. This position reports directly to the Senior Director of Analytical Development and QC (AD&QC). The successful candidate will also provide mentorship and GMP compliance guidance for the ADQC department. Essential Functions: • Oversee Vaxcyte QC, stability program and reference standard program. • Ensure quality and compliance of QC activities, and accountable for timely deliverables of the analytical method transfer , implementation and validation at CMO s , as well as stability studies, expiry dating/shelf life of raw material, intermediates, d rug substance and drug products and reference standard qualification. • Serve as decision maker for QC, stability and reference standard program, provide clear rationale and thorough supporting data to gain the CMC team endorsement of the decision. • Evaluate and audit CMOs for QC release testing and stability studies, provide recommendation to CMC team for QC site selection of various programs from e arly to late clinical phases • Design and implement team structure and growth plan to meet the company short term business needs and support company long term growth plan. • Manage performance of the team to ensure alignment towards goals; set SMART goals for the team members; ensures teams have the right mix of talent and resources to meet/exceed goals • Develop, implement and ensure compliance of the SOPs for stability program • Establish phase appropriate reference standard program and ensure its compliance to industry guidance and HA regulations. meets compliance to health authority expectation • Collaborate with Analytical Develop Scientists, Formulation, Process Development, Conjugation to gain the necessary method and product knowledge • Review analytical method development data, reports and method document to be transferred to CMOs • Review and approve all QC related deviation, CAPA and their associated investigation reports. • Author relevant regulatory submission and address health autho rity questions for IND approval • Manage relationships with existing and new CMOs, manage timelines and cost for the analytical method transfer, method qualification/validation and stability studies Requirements: • MS or BS with 20+ years of industry experience in Pharma / Biotech industry required • Demonstrate sound complex decision making skills and exhibit good judgment. Make decision with understanding of the strategic context and short and long term impact of decisions on other departments or functional a reas b efore making them; able to decide and act effectively without having the whole picture; • Result oriented; good judgment in directing attention and effort across competing priorities, especially when resource constrained; implements "best practices" or leading - edge quality standards; • Project management skills including the ability to manage project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line - management • Track record of building strong functional team, able to leverages understanding of strengths and weaknesses of team members in positioning them in the team; ability to anticipate and implements changes in roles and accountabilities in response to changes in the work environment; en sures teams have the right mix of talent and resources to meet/exceed goals; • Solid understanding of product development activities in biotech/drug/vaccine development, including key interdependencies, and knowledge of proven development strategies and tac tics • Expert analytical skills for integrating and interpreting interdisciplinary project information; thorough understanding of the drug/vaccine development process • Solid understanding of relevant FDA, EU, and ICH regulatory guidelines as applicable to ana lytical method qualification/validation for small molecules, biologics and vaccines, stability study design and expiry dating • Demonstrated ability of applying the regulatory guidance to formulate practical solutions and phase appropriate analytical transfe r, validation and stability strategy • Ability to work globally with CMOs in different countries and continents • U nderstanding of various analytical chemistry methodology principles and successful track record of method transfer, trouble shooting and validation for GMP release and stability testing, as well as stability study design and expiry/shelf life establish ment • Self -starter and resourceful problem solver, able to move up learning curve independently and map out intermediate milestones to achieve project goals. • Experience in IND, NDA and BLA submission is highly preferred • Extensive technical writing experience in drafting analytical method transfer, qualification and validation protocols, reports, and method SOPs • Strong interpersonal skills; ability to communicate effectively both verbally and in written formats • Ability to work in a fast - paced, cross - functional environment and collaborate effectively with other team members Reports to: Senior Director, Analytical Development & Quality Control Location: Foster City, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
01/26/2021
Full time
Vaxcyte, Inc. (Nasdaq: PCVX) is a next - generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell - free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our pipeline includes pneumococcal conjugate vaccine, or PCV, candidates that w e believe are the most broad - spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX - 24, is a preclinical, 24 - valent broad - spectrum pneumococcal conjugate PCV with precl inical proof -of- concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX - XP, a PCV with an expanded breadth of coverage of at least 30 strains, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; VAX - A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX - PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds. Summary: Vaxcyte is looking for an energetic and talented individual to join Vaxcyte 's Vac cine Product Development organization as a Director within Analytical Development and QC (ADQC) . The primary function of t his director level position is to oversee the QC activities and compliance such as analytical method transfer to the CMO, the method validation and release and stability testing. The person will also be the functional decision maker for QC, stability and reference standard program strategic decision s, and serve as a key contributor for company long term growth. This position reports directly to the Senior Director of Analytical Development and QC (AD&QC). The successful candidate will also provide mentorship and GMP compliance guidance for the ADQC department. Essential Functions: • Oversee Vaxcyte QC, stability program and reference standard program. • Ensure quality and compliance of QC activities, and accountable for timely deliverables of the analytical method transfer , implementation and validation at CMO s , as well as stability studies, expiry dating/shelf life of raw material, intermediates, d rug substance and drug products and reference standard qualification. • Serve as decision maker for QC, stability and reference standard program, provide clear rationale and thorough supporting data to gain the CMC team endorsement of the decision. • Evaluate and audit CMOs for QC release testing and stability studies, provide recommendation to CMC team for QC site selection of various programs from e arly to late clinical phases • Design and implement team structure and growth plan to meet the company short term business needs and support company long term growth plan. • Manage performance of the team to ensure alignment towards goals; set SMART goals for the team members; ensures teams have the right mix of talent and resources to meet/exceed goals • Develop, implement and ensure compliance of the SOPs for stability program • Establish phase appropriate reference standard program and ensure its compliance to industry guidance and HA regulations. meets compliance to health authority expectation • Collaborate with Analytical Develop Scientists, Formulation, Process Development, Conjugation to gain the necessary method and product knowledge • Review analytical method development data, reports and method document to be transferred to CMOs • Review and approve all QC related deviation, CAPA and their associated investigation reports. • Author relevant regulatory submission and address health autho rity questions for IND approval • Manage relationships with existing and new CMOs, manage timelines and cost for the analytical method transfer, method qualification/validation and stability studies Requirements: • MS or BS with 20+ years of industry experience in Pharma / Biotech industry required • Demonstrate sound complex decision making skills and exhibit good judgment. Make decision with understanding of the strategic context and short and long term impact of decisions on other departments or functional a reas b efore making them; able to decide and act effectively without having the whole picture; • Result oriented; good judgment in directing attention and effort across competing priorities, especially when resource constrained; implements "best practices" or leading - edge quality standards; • Project management skills including the ability to manage project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line - management • Track record of building strong functional team, able to leverages understanding of strengths and weaknesses of team members in positioning them in the team; ability to anticipate and implements changes in roles and accountabilities in response to changes in the work environment; en sures teams have the right mix of talent and resources to meet/exceed goals; • Solid understanding of product development activities in biotech/drug/vaccine development, including key interdependencies, and knowledge of proven development strategies and tac tics • Expert analytical skills for integrating and interpreting interdisciplinary project information; thorough understanding of the drug/vaccine development process • Solid understanding of relevant FDA, EU, and ICH regulatory guidelines as applicable to ana lytical method qualification/validation for small molecules, biologics and vaccines, stability study design and expiry dating • Demonstrated ability of applying the regulatory guidance to formulate practical solutions and phase appropriate analytical transfe r, validation and stability strategy • Ability to work globally with CMOs in different countries and continents • U nderstanding of various analytical chemistry methodology principles and successful track record of method transfer, trouble shooting and validation for GMP release and stability testing, as well as stability study design and expiry/shelf life establish ment • Self -starter and resourceful problem solver, able to move up learning curve independently and map out intermediate milestones to achieve project goals. • Experience in IND, NDA and BLA submission is highly preferred • Extensive technical writing experience in drafting analytical method transfer, qualification and validation protocols, reports, and method SOPs • Strong interpersonal skills; ability to communicate effectively both verbally and in written formats • Ability to work in a fast - paced, cross - functional environment and collaborate effectively with other team members Reports to: Senior Director, Analytical Development & Quality Control Location: Foster City, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our pipeline includes pneumococcal conjugate vaccine, or PCV, candidates that we believe are the most broad-spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate PCV with preclinical proof-of- concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of strain coverage, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds. Summary: Vaxcyte is looking for an energetic and talented individual to join the Formulation and Drug Product Development team. The primary responsibility for the incumbent will be to support the late stage activities of the Drug Product (DP) team in readiness for phase 3 clinical studies and through commercial launch. Due to the number of antigens and the suspended adjuvant system, this is arguably one of the most complex Drug Products in clinical development, so it is an incredible opportunity for the right candidate to make a significant impact on the product, the company, and the industry. This is a senior position and will require the candidate to have a high level of independence, scientific judgement, and leadership abilities. Essential Activities: • Evaluate, select, and oversee an appropriate fill finish CMO service provider to support early, late, and commercial stage manufacturing deliverables • In concert with the CMC team, design and oversee late-stage process characterization and process validation strategies consistent with CMC-regulatory guidance • Provide engineering leadership to generate the appropriate solutions for successful commercial mixing of the DP intermediates that allows compounding of 24 Drug Substances (DS) • Generation, testing, and validation of scalable mixing solutions of the DP bulk suspension mixture to ensure adequate homogeneity during the DP final fill. • Downscale of the above engineering solutions, where appropriate and possible, for utilization and facilitation of internal development work • Facilitate cross-functional process risk analysis using appropriate tools such as FMEA, leading to the identification of CPPs and CQAs • Establish supply chain logistics for the shipping of DS/intermediates/DP bulk under liquid or frozen conditions with suitable container closure systems Requirements: • BSc or MSc in Chemical Engineering, Process Engineering, Pharmaceutical Development preferred, with >15 year of industrial experience; or PhD with >10 years. • Experience in late-stage clinical manufacturing within fill finish sites under GMP regulations; it is mandatory that the successful candidate be entirely conversant with GMP manufacturing • Direct experience of chemical engineering in the biological manufacturing space, leading to custom engineering solutions • Experience in the progression of such engineering solutions from early to late clinical stage and through commercial launch, preferably in the fill/finish arena • Experience in the development of scaleup/down models and how they pertain to mixing of DP bulk, preferably suspension systems • Experience in validation of DP processes, including the use of QbD as required • Experience in leading the evaluation, selection and oversight of CMOs that perform DP fill finish activities • An understanding of the design and management of logistical supply chains to enable bespoke fill finish activities • Strong interpersonal and leadership skills; ability to communicate effectively both verbally and in written formats • Ability to work within in a fast-paced, cross functional environment, multitasking as needed Reports to: Director of Formulation and Drug Product Development Location: Foster City, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.
01/26/2021
Full time
Vaxcyte, Inc. (Nasdaq: PCVX) is a next-generation vaccine company seeking to improve global health by developing superior and novel vaccines designed to prevent some of the most common and deadly infectious diseases worldwide. Our exclusively licensed cell-free protein synthesis platform and our proprietary know how enable us to design and produce optimized protein carriers and antigens, the critical building blocks of vaccines, in ways that we believe conventional vaccine technologies cannot. Our pipeline includes pneumococcal conjugate vaccine, or PCV, candidates that we believe are the most broad-spectrum PCV candidates currently in development, targeting the $7 billion global pneumococcal vaccine market. Our lead vaccine candidate, VAX-24, is a preclinical, 24-valent broad-spectrum pneumococcal conjugate PCV with preclinical proof-of- concept demonstrating potential to replace the standard of care that we expect to advance into clinical trials in the second half of 2021. Our pipeline also includes VAX-XP, a PCV with an expanded breadth of strain coverage, including newly emerging strains responsible for invasive pneumococcal disease and antibiotic resistance; VAX-A1, a prophylactic vaccine candidate designed to prevent Group A Strep infections; and VAX-PG, a therapeutic vaccine candidate designed to slow or stop the progression of periodontal disease by targeting the keystone pathogen responsible for this chronic, oral inflammatory disease. We completed our initial public offering in June 2020, raising $287.5 million in gross proceeds. Summary: Vaxcyte is looking for an energetic and talented individual to join the Formulation and Drug Product Development team. The primary responsibility for the incumbent will be to support the late stage activities of the Drug Product (DP) team in readiness for phase 3 clinical studies and through commercial launch. Due to the number of antigens and the suspended adjuvant system, this is arguably one of the most complex Drug Products in clinical development, so it is an incredible opportunity for the right candidate to make a significant impact on the product, the company, and the industry. This is a senior position and will require the candidate to have a high level of independence, scientific judgement, and leadership abilities. Essential Activities: • Evaluate, select, and oversee an appropriate fill finish CMO service provider to support early, late, and commercial stage manufacturing deliverables • In concert with the CMC team, design and oversee late-stage process characterization and process validation strategies consistent with CMC-regulatory guidance • Provide engineering leadership to generate the appropriate solutions for successful commercial mixing of the DP intermediates that allows compounding of 24 Drug Substances (DS) • Generation, testing, and validation of scalable mixing solutions of the DP bulk suspension mixture to ensure adequate homogeneity during the DP final fill. • Downscale of the above engineering solutions, where appropriate and possible, for utilization and facilitation of internal development work • Facilitate cross-functional process risk analysis using appropriate tools such as FMEA, leading to the identification of CPPs and CQAs • Establish supply chain logistics for the shipping of DS/intermediates/DP bulk under liquid or frozen conditions with suitable container closure systems Requirements: • BSc or MSc in Chemical Engineering, Process Engineering, Pharmaceutical Development preferred, with >15 year of industrial experience; or PhD with >10 years. • Experience in late-stage clinical manufacturing within fill finish sites under GMP regulations; it is mandatory that the successful candidate be entirely conversant with GMP manufacturing • Direct experience of chemical engineering in the biological manufacturing space, leading to custom engineering solutions • Experience in the progression of such engineering solutions from early to late clinical stage and through commercial launch, preferably in the fill/finish arena • Experience in the development of scaleup/down models and how they pertain to mixing of DP bulk, preferably suspension systems • Experience in validation of DP processes, including the use of QbD as required • Experience in leading the evaluation, selection and oversight of CMOs that perform DP fill finish activities • An understanding of the design and management of logistical supply chains to enable bespoke fill finish activities • Strong interpersonal and leadership skills; ability to communicate effectively both verbally and in written formats • Ability to work within in a fast-paced, cross functional environment, multitasking as needed Reports to: Director of Formulation and Drug Product Development Location: Foster City, CA Compensation: The compensation package will be competitive and includes comprehensive benefits and an equity component.