GenScript
Head of Quality Control /Analytical DevelopmentHead of Quality Control /Analytical Development 1 day ago Be among the first 25 applicants
Not sure what skills you will need for this opportunity Simply read the full description below to get a complete picture of candidate requirements. The Head of QC/ AD will be responsible for leading the QC/AD team in ensuring that all in-process samples and final products meet established quality and regulatory standards within a biotechnology or pharmaceutical setting. This role will focus on analytical testing, method validation, and compliance with Good Manufacturing Practices (GMP).Essential responsibilities:Quality Control (QC):- Oversee day-to-day operations of the QC laboratory, Stability, and Sample & Data Management groups ensuring compliance with cGMP, FDA, and other regulatory requirements.- Develop and implement QC strategies, analytical methods, and quality control processes for biologics, cell and gene therapy, or pharmaceutical products.- Manage QC testing for in-process controls and finished products, ensuring accuracy and reliability.- Lead method validation, stability studies, and assay development activities in accordance with regulatory expectations.- Support regulatory submissions, audits, and inspections, ensuring all quality control activities align with compliance standards.- Collaborate with cross-functional teams, including Quality Assurance (QA), Manufacturing, and R&D, to resolve quality-related issuesAnalytical Development (AD):- Oversee development, qualification, and transfer of analytical methods for biologics, viral vectors, or cell therapy products.- Lead implementation of analytical platforms including HPLC/UPLC, CE, ELISA, qPCR/ddPCR, flow cytometry, etc.- Approve and review analytical protocols, development reports, method validation protocols, and transfer documentation.- Provide scientific and regulatory support for client projects, including IND/BLA/MAA submissions.Team & Strategic Leadership:- Build, mentor, and manage high-performing QC/AD teams to support multiple concurrent programs.- Lead all QC operations, including raw material, in-process, release, and stability testing.- Develop department goals, operational metrics, and resource plans to support corporate and client project timelines.- Provide strategic input into quality and analytical capabilities expansion, including equipment, digital tools, and automation.Qualifications:- Bachelor's or advanced degree in Biochemistry, Microbiology, Biotechnology, or a related field.- 8+ years of relevant experience in biopharmaceutical quality control and analytical development, with around 5 years in a leadership role.- Strong knowledge of cGMP, ICH guidelines, and regulatory requirements for biologics, pharmaceuticals, or advanced therapies.- Hands-on experience with analytical techniques such as HPLC, ELISA, PCR, Flow Cytometry, and Cell-Based Assays.- Proven leadership skills with experience in managing QC or AD teams- Excellent problem-solving, organizational, and communication skills. Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionQuality Assurance Referrals increase your chances of interviewing at GenScript by 2x Get notified about new Head of Quality Control jobs in
Pennington, NJ . Cranbury, NJ $150,000.00-$250,000.00 2 weeks ago New Jersey, United States $450,000.00-$650,000.00 2 months ago Head of Quality Control /Analytical DevelopmentHead, Clinical and Safety Quality Assurance Trenton, NJ $145,349.00-$227,108.00 1 month ago Piscataway, NJ $110,000.00-$160,000.00 3 days ago Grill Cook - Part Time - St Mary Medical CenterGrill Cook - Part Time - St Mary Medical CenterPrepared Meals and Rotisserie Chicken AssociatePrepared Meals and Rotisserie Chicken AssociateFreezer, Cooler and Deli Stocker AssociateFreezer, Cooler and Deli Stocker Associate Pennington, NJ $77,200.00-$119,875.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr
Not sure what skills you will need for this opportunity Simply read the full description below to get a complete picture of candidate requirements. The Head of QC/ AD will be responsible for leading the QC/AD team in ensuring that all in-process samples and final products meet established quality and regulatory standards within a biotechnology or pharmaceutical setting. This role will focus on analytical testing, method validation, and compliance with Good Manufacturing Practices (GMP).Essential responsibilities:Quality Control (QC):- Oversee day-to-day operations of the QC laboratory, Stability, and Sample & Data Management groups ensuring compliance with cGMP, FDA, and other regulatory requirements.- Develop and implement QC strategies, analytical methods, and quality control processes for biologics, cell and gene therapy, or pharmaceutical products.- Manage QC testing for in-process controls and finished products, ensuring accuracy and reliability.- Lead method validation, stability studies, and assay development activities in accordance with regulatory expectations.- Support regulatory submissions, audits, and inspections, ensuring all quality control activities align with compliance standards.- Collaborate with cross-functional teams, including Quality Assurance (QA), Manufacturing, and R&D, to resolve quality-related issuesAnalytical Development (AD):- Oversee development, qualification, and transfer of analytical methods for biologics, viral vectors, or cell therapy products.- Lead implementation of analytical platforms including HPLC/UPLC, CE, ELISA, qPCR/ddPCR, flow cytometry, etc.- Approve and review analytical protocols, development reports, method validation protocols, and transfer documentation.- Provide scientific and regulatory support for client projects, including IND/BLA/MAA submissions.Team & Strategic Leadership:- Build, mentor, and manage high-performing QC/AD teams to support multiple concurrent programs.- Lead all QC operations, including raw material, in-process, release, and stability testing.- Develop department goals, operational metrics, and resource plans to support corporate and client project timelines.- Provide strategic input into quality and analytical capabilities expansion, including equipment, digital tools, and automation.Qualifications:- Bachelor's or advanced degree in Biochemistry, Microbiology, Biotechnology, or a related field.- 8+ years of relevant experience in biopharmaceutical quality control and analytical development, with around 5 years in a leadership role.- Strong knowledge of cGMP, ICH guidelines, and regulatory requirements for biologics, pharmaceuticals, or advanced therapies.- Hands-on experience with analytical techniques such as HPLC, ELISA, PCR, Flow Cytometry, and Cell-Based Assays.- Proven leadership skills with experience in managing QC or AD teams- Excellent problem-solving, organizational, and communication skills. Seniority level
Seniority levelDirector Employment type
Employment typeFull-time Job function
Job functionQuality Assurance Referrals increase your chances of interviewing at GenScript by 2x Get notified about new Head of Quality Control jobs in
Pennington, NJ . Cranbury, NJ $150,000.00-$250,000.00 2 weeks ago New Jersey, United States $450,000.00-$650,000.00 2 months ago Head of Quality Control /Analytical DevelopmentHead, Clinical and Safety Quality Assurance Trenton, NJ $145,349.00-$227,108.00 1 month ago Piscataway, NJ $110,000.00-$160,000.00 3 days ago Grill Cook - Part Time - St Mary Medical CenterGrill Cook - Part Time - St Mary Medical CenterPrepared Meals and Rotisserie Chicken AssociatePrepared Meals and Rotisserie Chicken AssociateFreezer, Cooler and Deli Stocker AssociateFreezer, Cooler and Deli Stocker Associate Pennington, NJ $77,200.00-$119,875.00 2 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr