Head of Quality Control /Analytical Development Pennington, NJ - GenScript USA : Job Details

Head of Quality Control /Analytical Development

Pennington, NJ

About GenScriptGenScript Biotech Corporation (Stock Code: 1548.HK) is a global biotechnology group. Founded in 2002, GenScript has an established global presence across North America, Europe, the Greater China, and Asia Pacific. GenScript's businesses encompass four major categories based on its leading gene synthesis technology, including operation as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy.GenScript is committed to striving towards its vision of being the most reliable biotech company in the world to make humans and nature healthier through biotechnology.About ProBioProBio proactively provides end-to-end CDMO service from drug discovery to commercialization with proactive strategies, professional solutions and efficient processes in cell and gene therapy, vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. ProBio's total cell and gene therapy solution covers CMC of plasmid and virus for IND filing as well as clinical manufacturing and commercial manufacturing.

Job Scope:

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).

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 issues

Analytical 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.

#LW

GenScript USA Inc/ProBio Inc. is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is the Company's policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

GenScript USA Inc./ProBio Inc. maintains a drug-free workplace.

Please note: Genscript USA Inc./ProBio Inc. will only contact candidates through verified application sources. GenScript/Probio does not request personal information from candidates through individual email or any other platform.

Apply for this job

*

indicates a required field

First Name *

Last Name *

Preferred First Name

Email *

Phone

Resume/CV

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

Enter manually

Accepted file types: pdf, doc, docx, txt, rtf

#J-18808-Ljbffr