Position Summary
The Senior Director, Quality Control (QC) provides scientific and operational leadership for all QC activities supporting a pipeline spanning monoclonal antibodies (mAbs), RNA therapeutics (mRNA, siRNA, ASOs), and oligonucleotide antibody conjugates. In a virtual operating model where testing, development, and manufacturing are outsourced, the Director establishes governance with CDMOs/CROs, oversees analytical strategy, and manages method lifecycle requirements.
Key Responsibilities
· External QC Oversight
o Provide governance of QC testing at CDMOs/CROs.
o Review partner QC deliverables including CoAs, OOS/OOT investigations, and stability data.
o Drive external CDMO/CRO schedules to achieve overall project schedules
· Cross-Modality Analytical C QC Strategy
o Lead QC strategy across antibodies, RNA, and conjugate modalities.
o Drive modality-specific analytical approaches including glycan profiling, potency assays, RNA integrity/capping analysis, and DAR characterization.
· Method Lifecycle Management
o Oversee transfer, qualification, validation, and maintenance of analytical methods across all modalities.
· Regulatory Compliance
o Ensure QC activities align with cGMP, ICH, FDA, EMA expectations.
o Support QC sections of regulatory submissions.
· Product Quality C Release
o Oversee external testing and release of mAb, RNA, and conjugated DS/DP.
· Stability Program Oversight
o Manage outsourced stability programs for biologics and RNA products.
o Drive external CDMO/CRO schedules to achieve overall project schedules
· Organizational Leadership
o Build and manage a lean QC function optimized for a virtual environment.
Qualifications
· 10+ years QC across biologics and/or RNA
· 5+ years’ experience overseeing outsourced QC and CDMO partners.
· Experience in cGMP environment is a must
· Built and manage a lean QC function optimized for a virtual environment.
· Experience with oligonucleotide antibody conjugates is preferred
Additional Information- Travel: ~15–30% to partner sites.
This role offers an exciting opportunity for a dedicated professional committed to advancing quality excellence within the biotech industry. We invite qualified candidates who thrive on leadership challenges and continuous improvement initiatives to apply today.
Pay: $200,000.00 - $275,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible schedule
- Health insurance
- Life insurance
- Paid time off
- Parental leave
- Relocation assistance
- Tuition reimbursement
- Vision insurance
Experience:
- QC across biologics and/or RNA: 10 years (Required)
Work Location: In person
