Biologics Quality Assurance Lead
3 days ago
Role Overview:
We are seeking a highly experienced Senior Manager/Associate Director, Quality Control to lead our QC activities for antibody and fusion protein products across our pipeline.
About the Job:
In this role, you will develop strategies and execute QC activities for all pipeline programs. This includes in-process/release/stability testing, specification justification and maintenance, and critical documentation.
Key Responsibilities:
- Develop strategies and execute QC activities for all pipeline programs
- Oversee CDMOs for phase-appropriate analytical method development, qualification, validation, and transfer for in-process testing, drug substance (DS) and drug product (DP) release and stability testing
- Manage GMP data of DS and DP batch release and stability programs, monitor trends, troubleshoot QC method performance, and investigate OOT/OOS
- Build and maintain a mature QC infrastructure, implementing procedures to support the development of therapeutic candidates in a GMP-compliant manner
- Contribute to analytical regulatory strategies, author technical protocols, reports and relevant analytical sections for regulatory filings
- Manage reference standards and critical reagents qualification and inventory for multiple programs at CDMOs and third-party testing sites
- Work closely with CMC team and key personnel including Quality Assurance, Regulatory, and Project Management, and with external CDMO and Contract Testing Laboratories to execute QC activities according to program needs
Requirements:
- Advanced degree in a relevant discipline (e.g., analytical chemistry, biochemistry or related field) and 6-8+ years of analytical development & quality control experience with complex biologics, particularly Fc-fusion proteins and monoclonal antibodies from early to late-stage development (or equivalent combination of education and experience)
- Expertise/competence in analytical techniques for biologics such as HPLC, CE-SDS, icIEF spectroscopy, ELISA, cell-based bioassays etc.
- Experience managing/partnering with CDMOs and third-party testing sites to establish and generate GMP QC data
- Experience managing large analytical data sets including method transfer, qualification, validation, lot release, and stability
- Experience authoring and reviewing analytical methods, technical reports, and regulatory filings
- Knowledge and understanding of cGMP/ ICH/ FDA/ EU guidance and regulations
- Experience qualifying and managing reference standard and critical reagents to support QC testing
- Experience with statistical analysis and statistical software is a plus
- Excellent interpersonal and communication skills and demonstrated ability to effectively collaborate across functional lines in a team-oriented environment
- Ability to work independently and multi-task in a fast-paced organization
- $180,000 - $220,000 per year, depending on experience
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