Quotient Sciences: Molecule to Cure. Fast.We accelerate drug development by integrating formulation development, clinical testing, data sciences, and manufacturing into one seamless process. Our proprietary platform, Translational Pharmaceutics , shortens timelines by 9-12 months on average. Arcinova, our specialist arm in Reading and Alnwick, UK, delivers end-to-end drug substance and early drug product services, including bioanalysis and radiolabeling-streamlining early development from candidate selection to proof of concept. Why join us? Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact-fast. The Role: Overall responsibility for quality of laboratory processing for assigned duties To ensure study data is collected to a high quality in accordance with ICH-GCP, protocol and lab manual To ensure subject safety at all times Main Tasks and Responsibilities: Provides encouragement, support, positive reinforcement to laboratory technicians Oversees sample labelling, processing and shipping duties as required Ensures lab set up and cleaning duties are performed on a daily, weekly and monthly basis Processes biological samples as per lab manual when required Attends all pre-study meetings, including SIVs and protocol trainings for assigned studies Reviews/Approves lab manual prior to the start of a study Ensures sample shipments are organized and sent to clients as per the lab manual and study timeline Ensures sample shipment checklists and sample manifests are generated and reviewed for all sample shipments Performs sample processing checks on all studies to ensure compliance with lab manual and SOPs Ensures the QC of laboratory source data and performs QC as necessary Works in a safe and responsible manner at all times Reviews protocol specimen processing requirements and ensures that an adequate inventory of necessary supplies are available or ordered and delivered prior to study start and throughout study conduct Reviews/approves specimen labels prior to tube preparation Ensures collection tubes and freezer vials are properly labelled and set up prior to scheduled sample collection Processes samples and assists with laboratory duties as needed Assists with SOP reviews and edits Works with Data Entry team to resolve discrepancies/queries noted during lab tracking or monitoring visits Assists with training of new laboratory staff and ensures lab staff are fully trained and signed off in the relevant SOP/competency and protocols before working unsupervised or on a study May serve as a back up to the Clinical Laboratory Manager when required The Candidate: Laboratory / Sample processing experience essential Education or equivalent experience in a science, health or customer related field Supervisory experience preferred Application Requirements When applying for a position with Quotient Sciences to be able to work in our organisation you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined. Our Commitment to Diversity, Equity and Inclusion Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. Specifically we will not discriminate on the basis of race, colour, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws. This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
10/09/2025
Full time
Quotient Sciences: Molecule to Cure. Fast.We accelerate drug development by integrating formulation development, clinical testing, data sciences, and manufacturing into one seamless process. Our proprietary platform, Translational Pharmaceutics , shortens timelines by 9-12 months on average. Arcinova, our specialist arm in Reading and Alnwick, UK, delivers end-to-end drug substance and early drug product services, including bioanalysis and radiolabeling-streamlining early development from candidate selection to proof of concept. Why join us? Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact-fast. The Role: Overall responsibility for quality of laboratory processing for assigned duties To ensure study data is collected to a high quality in accordance with ICH-GCP, protocol and lab manual To ensure subject safety at all times Main Tasks and Responsibilities: Provides encouragement, support, positive reinforcement to laboratory technicians Oversees sample labelling, processing and shipping duties as required Ensures lab set up and cleaning duties are performed on a daily, weekly and monthly basis Processes biological samples as per lab manual when required Attends all pre-study meetings, including SIVs and protocol trainings for assigned studies Reviews/Approves lab manual prior to the start of a study Ensures sample shipments are organized and sent to clients as per the lab manual and study timeline Ensures sample shipment checklists and sample manifests are generated and reviewed for all sample shipments Performs sample processing checks on all studies to ensure compliance with lab manual and SOPs Ensures the QC of laboratory source data and performs QC as necessary Works in a safe and responsible manner at all times Reviews protocol specimen processing requirements and ensures that an adequate inventory of necessary supplies are available or ordered and delivered prior to study start and throughout study conduct Reviews/approves specimen labels prior to tube preparation Ensures collection tubes and freezer vials are properly labelled and set up prior to scheduled sample collection Processes samples and assists with laboratory duties as needed Assists with SOP reviews and edits Works with Data Entry team to resolve discrepancies/queries noted during lab tracking or monitoring visits Assists with training of new laboratory staff and ensures lab staff are fully trained and signed off in the relevant SOP/competency and protocols before working unsupervised or on a study May serve as a back up to the Clinical Laboratory Manager when required The Candidate: Laboratory / Sample processing experience essential Education or equivalent experience in a science, health or customer related field Supervisory experience preferred Application Requirements When applying for a position with Quotient Sciences to be able to work in our organisation you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined. Our Commitment to Diversity, Equity and Inclusion Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. Specifically we will not discriminate on the basis of race, colour, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws. This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
Associate Director, Formulation Design Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients. We employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA. Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community that's focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast. We're looking for an Associate Director, Formulation Design to join our growing US team. Based in Philadelphia, you'll play a pivotal role in shaping and delivering early development strategies for our clients, ensuring their molecules progress efficiently and effectively through the development pipeline. The Role Lead the implementation of our US Translational Pharmaceutics strategy, aligned with global objectives. Oversee early development and clinical programs, ensuring seamless execution across R&D, GMP, and clinical operations. Act as a key technical leader and subject matter expert, guiding cross-functional teams and mentoring scientific staff. Collaborate closely with Business Development to support client engagement, site visits, and proposal development. Drive innovation by identifying and integrating new technologies that enhance our service offering. Manage resources effectively balancing project timelines, team capacity, and equipment utilization. Ensure scientific and regulatory excellence in all documentation, including batch records, protocols, and technical reports. Skills and experience A minimum of 10 years' experience in pharmaceutical development, with a strong focus on oral solid dosage forms. Deep expertise in modified release and solubility enhancement technologies (e.g., matrix systems, functional coatings, spray drying). Proven ability to apply QbD principles and design space methodologies. Strong leadership and client-facing skills, with a track record of building high-performing teams. Experience working in a GMP-regulated environment and navigating complex program challenges. Proficiency in Microsoft Office and scientific documentation. Application Requirements When applying for a position with Quotient Sciences to be able to work in our organisation you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined. Our Commitment to Diversity, Equity and Inclusion Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. Specifically we will not discriminate on the basis of race, colour, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws. This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
10/08/2025
Full time
Associate Director, Formulation Design Quotient Sciences is a drug development and manufacturing accelerator providing integrated programs and tailored services across the entire development pathway. Cutting through silos across a range of drug development capabilities, we help biotech and pharma customers save precious time and money in getting drugs to patients. We employ more than 1,100 talented individuals globally, located at state-of-the-art development, manufacturing and clinical facilities in the UK and USA. Science, Agility and Culture are the core components that define Quotient Sciences, enabling us to do what we do in the way that we do it. People join Quotient Sciences because we are a respected member of the drug development community that's focused on innovation and are driven by an unswerving belief that ideas need to become solutions, and molecules need to become cures, fast. Because humanity needs solutions, fast. We're looking for an Associate Director, Formulation Design to join our growing US team. Based in Philadelphia, you'll play a pivotal role in shaping and delivering early development strategies for our clients, ensuring their molecules progress efficiently and effectively through the development pipeline. The Role Lead the implementation of our US Translational Pharmaceutics strategy, aligned with global objectives. Oversee early development and clinical programs, ensuring seamless execution across R&D, GMP, and clinical operations. Act as a key technical leader and subject matter expert, guiding cross-functional teams and mentoring scientific staff. Collaborate closely with Business Development to support client engagement, site visits, and proposal development. Drive innovation by identifying and integrating new technologies that enhance our service offering. Manage resources effectively balancing project timelines, team capacity, and equipment utilization. Ensure scientific and regulatory excellence in all documentation, including batch records, protocols, and technical reports. Skills and experience A minimum of 10 years' experience in pharmaceutical development, with a strong focus on oral solid dosage forms. Deep expertise in modified release and solubility enhancement technologies (e.g., matrix systems, functional coatings, spray drying). Proven ability to apply QbD principles and design space methodologies. Strong leadership and client-facing skills, with a track record of building high-performing teams. Experience working in a GMP-regulated environment and navigating complex program challenges. Proficiency in Microsoft Office and scientific documentation. Application Requirements When applying for a position with Quotient Sciences to be able to work in our organisation you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined. Our Commitment to Diversity, Equity and Inclusion Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. Specifically we will not discriminate on the basis of race, colour, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws. This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
Quotient Sciences: Molecule to Cure. Fast.We accelerate drug development by integrating formulation development, clinical testing, data sciences, and manufacturing into one seamless process. Our proprietary platform, Translational Pharmaceutics , shortens timelines by 9-12 months on average. Arcinova, our specialist arm in Reading and Alnwick, UK, delivers end-to-end drug substance and early drug product services, including bioanalysis and radiolabeling-streamlining early development from candidate selection to proof of concept. Why join us? Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact-fast. Hiring for full-time and per diem schedules The Role Collects biological samples, performs phlebotomy, vital signs and ECG's in accordance with the specific activity schedule. Tracks overall study event schedule and participant compliance. To ensure study data is collected to a high quality in accordance with Good Clinical Practice (GCP) standards. To ensure subject safety at all times Main Tasks and Responsibilities: Responsible for collection of biological samples; e.g. urine, and sputum. Responsible for drawing blood specimens (by venepuncture) according to the times specified in the study schedules. Responsible for recording and maintaining records of blood draws and other biological specimen collections (per SOPs) via paper or electronic. Assist with the proper labelling and preparation of blood collection tubes when indicated. Assures that all necessary blood collection tubes, equipment and supplies are on the floor prior to blood draw time. Prepares the unit for any scheduled activities and upon completion removes all equipment and/or supplies from the floor. Able to take and record accurate vital signs; recognize and report any abnormal vital signs. Able to operate ECG machine and or holter if within scope of practice. Promptly reports any study participant's adverse event and/or lack of compliance to the Study Nurse Coordinator. Must be familiar with proper phlebotomy and laboratory procedures in compliance with OSHA regulations, Good Clinical Practices and Quotient Sciences Operating Procedures. Responsible for proper biomedical waste disposal procedures and schedules. Responsible for reading and understanding all protocols and schedules. Responsible for assisting in the recording and distributing of meals to study participants according to strict meal schedules. Assures that the unit is kept clean and orderly at all times and removes any items not permitted from the floor. Able to interact and maintain a professional demeanour with study participants during their inpatient stay. Responsible for observing confidentiality practices regarding any protocols, subject information and/or any relevant industry information at all times. Assists with the preparation of data collection binders and study documents as assigned by the Study Nurse Coordinator. Assists with any other duties as assigned. The Candidate Technical school phlebotomy training or Medical Assistant certificate. Minimum two years of active phlebotomy experience preferred. Required to have working knowledge of OSHA regulations and proper blood collection techniques (evaluable during employee orientation period). Application Requirements When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined. Our Commitment to Diversity, Equity and Inclusion Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today. Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws. This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
10/08/2025
Full time
Quotient Sciences: Molecule to Cure. Fast.We accelerate drug development by integrating formulation development, clinical testing, data sciences, and manufacturing into one seamless process. Our proprietary platform, Translational Pharmaceutics , shortens timelines by 9-12 months on average. Arcinova, our specialist arm in Reading and Alnwick, UK, delivers end-to-end drug substance and early drug product services, including bioanalysis and radiolabeling-streamlining early development from candidate selection to proof of concept. Why join us? Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact-fast. Hiring for full-time and per diem schedules The Role Collects biological samples, performs phlebotomy, vital signs and ECG's in accordance with the specific activity schedule. Tracks overall study event schedule and participant compliance. To ensure study data is collected to a high quality in accordance with Good Clinical Practice (GCP) standards. To ensure subject safety at all times Main Tasks and Responsibilities: Responsible for collection of biological samples; e.g. urine, and sputum. Responsible for drawing blood specimens (by venepuncture) according to the times specified in the study schedules. Responsible for recording and maintaining records of blood draws and other biological specimen collections (per SOPs) via paper or electronic. Assist with the proper labelling and preparation of blood collection tubes when indicated. Assures that all necessary blood collection tubes, equipment and supplies are on the floor prior to blood draw time. Prepares the unit for any scheduled activities and upon completion removes all equipment and/or supplies from the floor. Able to take and record accurate vital signs; recognize and report any abnormal vital signs. Able to operate ECG machine and or holter if within scope of practice. Promptly reports any study participant's adverse event and/or lack of compliance to the Study Nurse Coordinator. Must be familiar with proper phlebotomy and laboratory procedures in compliance with OSHA regulations, Good Clinical Practices and Quotient Sciences Operating Procedures. Responsible for proper biomedical waste disposal procedures and schedules. Responsible for reading and understanding all protocols and schedules. Responsible for assisting in the recording and distributing of meals to study participants according to strict meal schedules. Assures that the unit is kept clean and orderly at all times and removes any items not permitted from the floor. Able to interact and maintain a professional demeanour with study participants during their inpatient stay. Responsible for observing confidentiality practices regarding any protocols, subject information and/or any relevant industry information at all times. Assists with the preparation of data collection binders and study documents as assigned by the Study Nurse Coordinator. Assists with any other duties as assigned. The Candidate Technical school phlebotomy training or Medical Assistant certificate. Minimum two years of active phlebotomy experience preferred. Required to have working knowledge of OSHA regulations and proper blood collection techniques (evaluable during employee orientation period). Application Requirements When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined. Our Commitment to Diversity, Equity and Inclusion Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today. Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws. This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
Quotient Sciences: Molecule to Cure. Fast.We accelerate drug development by integrating formulation development, clinical testing, data sciences, and manufacturing into one seamless process. Our proprietary platform, Translational Pharmaceutics , shortens timelines by 9-12 months on average. Arcinova, our specialist arm in Reading and Alnwick, UK, delivers end-to-end drug substance and early drug product services, including bioanalysis and radiolabeling-streamlining early development from candidate selection to proof of concept. Why join us? Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact-fast. The Role Are you passionate about pharmaceutical science and eager to make a meaningful impact in a dynamic lab environment? We're looking for a motivated and detail-oriented Analytical Scientist to join our team in Philadelphia - Garnet Valley. This is your opportunity to grow your career while contributing to cutting-edge analytical development projects. As an Analytical Scientist I, you will work under supervision across various functional areas, including: Analytical method development, validation, and transfer activities. Formulation development work including material characterization and physical testing. API/raw material sampling and testing, in-process and finished product testing, cleaning verification swabbing and testing. Notebook/report review, training, and technical writing activities. Implementing, testing, using, or administrating LIMS. Adhering to Good Manufacturing Practice (GMP) standards. Main Tasks and Responsibilities Essential duties include, but are not limited to: Operate and troubleshoot instruments/equipment to test pharmaceutical samples including HPLC/UPLC, Dissolution apparatus, Karl-Fisher water content titrator, GC, FTIR, UV, and other analytical instruments as directed. Follow analytical test methods, compendial methods, experimental procedures, and SOPs. Document test results in laboratory notebook in real-time and communicate status of test results to supervisor. Peer review of laboratory notebooks for technical details. Maintain control of all project-related samples submitted to the laboratory. Initiate documentation process, compile data into reports, and author analytical test methods. Implement, test, use, or administrate Laboratory Information Management Systems (LIMS). Perform housekeeping to maintain a safe and orderly laboratory. Comply with all state and federal regulations including FDA, EPA, OSHA, DEA, and internal policies. Manage responsibilities efficiently to ensure accurate and timely data reports. Consult and work closely with supervisor regarding any issues with sample preparation, instrument performance, data acquisition and analysis as it applies to data integrity and accuracy Train on all the SOPs and company procedures on regular basis and remain up to date with the training curriculum Additional Responsibilities Remain current in profession and industry trends. Make positive contributions by suggesting improvements. Learn new skills, procedures, and processes including formulation development. Be available for other duties as required. Be available for overtime as needed. Qualifications and Experience To be successful in this role, you should have: B.S. in Chemistry or equivalent. 0-3 years of relevant experience or a combination of equivalent training, experience, and education. Understanding of experiment documentation and basic laboratory skills. Job Demands This role may involve: Very high concentration of work. Strict and tight deadlines. Managing multiple tasks/issues simultaneously. Working in a hazardous environment with strict safety procedures. Working outside normal working hours. Responding to client demands. If you're ready to take on a challenging and rewarding role in a fast-paced pharmaceutical environment, we encourage you to apply and become a part of our innovative team! Application Requirements When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined. Our Commitment to Diversity, Equity and Inclusion Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today. Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws. This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
10/08/2025
Full time
Quotient Sciences: Molecule to Cure. Fast.We accelerate drug development by integrating formulation development, clinical testing, data sciences, and manufacturing into one seamless process. Our proprietary platform, Translational Pharmaceutics , shortens timelines by 9-12 months on average. Arcinova, our specialist arm in Reading and Alnwick, UK, delivers end-to-end drug substance and early drug product services, including bioanalysis and radiolabeling-streamlining early development from candidate selection to proof of concept. Why join us? Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact-fast. The Role Are you passionate about pharmaceutical science and eager to make a meaningful impact in a dynamic lab environment? We're looking for a motivated and detail-oriented Analytical Scientist to join our team in Philadelphia - Garnet Valley. This is your opportunity to grow your career while contributing to cutting-edge analytical development projects. As an Analytical Scientist I, you will work under supervision across various functional areas, including: Analytical method development, validation, and transfer activities. Formulation development work including material characterization and physical testing. API/raw material sampling and testing, in-process and finished product testing, cleaning verification swabbing and testing. Notebook/report review, training, and technical writing activities. Implementing, testing, using, or administrating LIMS. Adhering to Good Manufacturing Practice (GMP) standards. Main Tasks and Responsibilities Essential duties include, but are not limited to: Operate and troubleshoot instruments/equipment to test pharmaceutical samples including HPLC/UPLC, Dissolution apparatus, Karl-Fisher water content titrator, GC, FTIR, UV, and other analytical instruments as directed. Follow analytical test methods, compendial methods, experimental procedures, and SOPs. Document test results in laboratory notebook in real-time and communicate status of test results to supervisor. Peer review of laboratory notebooks for technical details. Maintain control of all project-related samples submitted to the laboratory. Initiate documentation process, compile data into reports, and author analytical test methods. Implement, test, use, or administrate Laboratory Information Management Systems (LIMS). Perform housekeeping to maintain a safe and orderly laboratory. Comply with all state and federal regulations including FDA, EPA, OSHA, DEA, and internal policies. Manage responsibilities efficiently to ensure accurate and timely data reports. Consult and work closely with supervisor regarding any issues with sample preparation, instrument performance, data acquisition and analysis as it applies to data integrity and accuracy Train on all the SOPs and company procedures on regular basis and remain up to date with the training curriculum Additional Responsibilities Remain current in profession and industry trends. Make positive contributions by suggesting improvements. Learn new skills, procedures, and processes including formulation development. Be available for other duties as required. Be available for overtime as needed. Qualifications and Experience To be successful in this role, you should have: B.S. in Chemistry or equivalent. 0-3 years of relevant experience or a combination of equivalent training, experience, and education. Understanding of experiment documentation and basic laboratory skills. Job Demands This role may involve: Very high concentration of work. Strict and tight deadlines. Managing multiple tasks/issues simultaneously. Working in a hazardous environment with strict safety procedures. Working outside normal working hours. Responding to client demands. If you're ready to take on a challenging and rewarding role in a fast-paced pharmaceutical environment, we encourage you to apply and become a part of our innovative team! Application Requirements When applying for a position with Quotient Sciences to be able to work in our organization you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined. Our Commitment to Diversity, Equity and Inclusion Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organization. As a global employer, we recognize the value in having an organization that is a true reflection and representation of our society today. Specifically we will not discriminate on the basis of race, color, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws. This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
Quotient Sciences: Molecule to Cure. Fast.We accelerate drug development by integrating formulation development, clinical testing, data sciences, and manufacturing into one seamless process. Our proprietary platform, Translational Pharmaceutics , shortens timelines by 9-12 months on average. Arcinova, our specialist arm in Reading and Alnwick, UK, delivers end-to-end drug substance and early drug product services, including bioanalysis and radiolabeling-streamlining early development from candidate selection to proof of concept. Why join us? Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact-fast. An excellent opportunity for a Principal Investigator/ Medical Director to join Quotient Sciences - Miami, a dedicated, state-of-the-art, clinical pharmacology facility. The Miami site specializes in phase I clinical pharmacology studies with a proven track record of almost a thousand studies over the past 25 years. With 144 beds and a large recruitment database of 20,000 healthy volunteers, we're known for being able to rapidly start up new studies in record time and complete studies quickly with full cohorts of subjects. Join us as a Principal Investigator/ Medical Director and help us to develop new medicines and get them to patients faster. Summary of job purpose Serve as Principal Investigator or Sub-Investigator on protocols undertaken by Quotient Sciences-Miami and is responsible for overseeing medical services and licensed professional staff Comply & adhere to GCP guidelines and regulations Ensure study data is collected in accordance with Good Clinical Practice (GCP) standards Ensure subject safety at all times Qualifications and experience required for competent performance Active Medical Doctor or Doctor of Osteopathy License, State of Florida Minimum of five years of clinical research experience preferred Board Certified in a medical specialty Must not be debarred, disqualified, or restricted by the FDA or State of Florida Maintains BLS and ACLS certification Maintains CITI Program certification Main tasks and responsibilities Serve as Principal Investigator or Sub-Investigator on FDA form 1572 for protocols conducted. Satisfactorily perform and comply with all responsibilities of a clinical investigator including, but not limited to those specified in the ICH Guidelines for Good Clinical Practice, FDA form1572, FDA Rules and Regulations and other Investigator's obligations specified in pharmaceutical company protocols and contracts Supervise morning drug administration at the overnight facility on those days when pharmacokinetic profiles are obtained or Physician presence is required for safety purposes Directly supervise the final selection of study participants from the time of clinic admission until actual drug exposure takes place Attends to adverse medical events Perform physical exams, read ECG's and review laboratory data for protocols conducted Review screening results as necessary to assemble qualified research participant cohorts according to protocol stipulations Work in concert with site and Clinical Operations to provide supervision and organization of physician, sub-Investigators, nurses and clinical staff Maintain familiarity with crash cart and emergency resuscitation procedures Participate in on-call rotation Review completed data entry and sign-off of completed study documentation in a timely manner including a careful review and sign-off of adverse assessments, study interim summaries, as well as clinical study reports Participate in writing and editing of protocols and informed consents for clinical studies Be available and participate in communications with sponsor in regard to study progress Be available for FDA inspections and Pharmaceutical Sponsor Audits Additional Tasks/responsibilities Review SOPs and assist with SOP revisions when applicable Assist in drafting Notes to File Identify quality issues and help draft and implement CAPAs Attend department and sponsor meetings Assist in training new staff (other MDs and/or ARNPs/PAs) as necessary Give educational lectures and participates in Mock Code training as necessary Job Demands The job may involve the following: Very high concentration of work Strict and tight deadlines Having to juggle a range of tasks/issues simultaneously Working in a hazardous environment with high requirement to follow safety procedures Working outside normal working hours Needing to respond to client demands Application Requirements When applying for a position with Quotient Sciences to be able to work in our organisation you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined. Our Commitment to Diversity, Equity and Inclusion Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. Specifically we will not discriminate on the basis of race, colour, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws. This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
10/08/2025
Full time
Quotient Sciences: Molecule to Cure. Fast.We accelerate drug development by integrating formulation development, clinical testing, data sciences, and manufacturing into one seamless process. Our proprietary platform, Translational Pharmaceutics , shortens timelines by 9-12 months on average. Arcinova, our specialist arm in Reading and Alnwick, UK, delivers end-to-end drug substance and early drug product services, including bioanalysis and radiolabeling-streamlining early development from candidate selection to proof of concept. Why join us? Because every day counts when bringing new medicines to patients. Our 1,000+ experts across the US, UK, and beyond are united by science, agility, and a culture that turns ideas into impact-fast. An excellent opportunity for a Principal Investigator/ Medical Director to join Quotient Sciences - Miami, a dedicated, state-of-the-art, clinical pharmacology facility. The Miami site specializes in phase I clinical pharmacology studies with a proven track record of almost a thousand studies over the past 25 years. With 144 beds and a large recruitment database of 20,000 healthy volunteers, we're known for being able to rapidly start up new studies in record time and complete studies quickly with full cohorts of subjects. Join us as a Principal Investigator/ Medical Director and help us to develop new medicines and get them to patients faster. Summary of job purpose Serve as Principal Investigator or Sub-Investigator on protocols undertaken by Quotient Sciences-Miami and is responsible for overseeing medical services and licensed professional staff Comply & adhere to GCP guidelines and regulations Ensure study data is collected in accordance with Good Clinical Practice (GCP) standards Ensure subject safety at all times Qualifications and experience required for competent performance Active Medical Doctor or Doctor of Osteopathy License, State of Florida Minimum of five years of clinical research experience preferred Board Certified in a medical specialty Must not be debarred, disqualified, or restricted by the FDA or State of Florida Maintains BLS and ACLS certification Maintains CITI Program certification Main tasks and responsibilities Serve as Principal Investigator or Sub-Investigator on FDA form 1572 for protocols conducted. Satisfactorily perform and comply with all responsibilities of a clinical investigator including, but not limited to those specified in the ICH Guidelines for Good Clinical Practice, FDA form1572, FDA Rules and Regulations and other Investigator's obligations specified in pharmaceutical company protocols and contracts Supervise morning drug administration at the overnight facility on those days when pharmacokinetic profiles are obtained or Physician presence is required for safety purposes Directly supervise the final selection of study participants from the time of clinic admission until actual drug exposure takes place Attends to adverse medical events Perform physical exams, read ECG's and review laboratory data for protocols conducted Review screening results as necessary to assemble qualified research participant cohorts according to protocol stipulations Work in concert with site and Clinical Operations to provide supervision and organization of physician, sub-Investigators, nurses and clinical staff Maintain familiarity with crash cart and emergency resuscitation procedures Participate in on-call rotation Review completed data entry and sign-off of completed study documentation in a timely manner including a careful review and sign-off of adverse assessments, study interim summaries, as well as clinical study reports Participate in writing and editing of protocols and informed consents for clinical studies Be available and participate in communications with sponsor in regard to study progress Be available for FDA inspections and Pharmaceutical Sponsor Audits Additional Tasks/responsibilities Review SOPs and assist with SOP revisions when applicable Assist in drafting Notes to File Identify quality issues and help draft and implement CAPAs Attend department and sponsor meetings Assist in training new staff (other MDs and/or ARNPs/PAs) as necessary Give educational lectures and participates in Mock Code training as necessary Job Demands The job may involve the following: Very high concentration of work Strict and tight deadlines Having to juggle a range of tasks/issues simultaneously Working in a hazardous environment with high requirement to follow safety procedures Working outside normal working hours Needing to respond to client demands Application Requirements When applying for a position with Quotient Sciences to be able to work in our organisation you must be aged 18 years or over and not have been debarred by the FDA. If you indicate you are under the age of 18 or have been debarred then your application will be automatically declined. Our Commitment to Diversity, Equity and Inclusion Quotient Sciences are advocates for positive change and conscious inclusion. We strive to create a diverse Quotient workforce and develop a workplace culture that provides a sense of acceptance for every person within our organisation. As a global employer, we recognise the value in having an organisation that is a true reflection and representation of our society today. Specifically we will not discriminate on the basis of race, colour, creed, religion, gender, gender identity, pregnancy, marital status, partnership status, domestic violence victim status, sexual orientation, age, national origin, alienage or citizenship status, veteran or military status, disability, medical condition, genetic information, caregiver status, unemployment status or any other characteristic prohibited by federal, state and/or local laws. This applies to all aspects of employment, including hiring, promotion, demotion, compensation, training, working conditions, transfer, job assignments, benefits, layoff, and termination.
