QC Manager, Lab Support
About The Position
We are seeking an experienced and motivated QC Manager, Lab Support to lead the lab support function within our biologics drug substance manufacturing facility. This role is critical to ensuring seamless QC laboratory operations, overseeing sample management, stability programs, and core lab support activities that enable compliant, inspection-ready performance. As a key leader, you will drive operational excellence, support both clinical and commercial manufacturing, and ensure alignment across QC and manufacturing teams. This is an onsite role (Monday–Friday) with occasional off-shift and weekend support as needed.
Requirements
- Bachelor’s degree in Biological Sciences or related field
- Minimum 5 years of QC experience managing samples and stability pulls in a GMP-regulated biologics or pharmaceutical environment
- At minimum 2 years of supervisory or team leadership experience
- Experience with autoclave and glasswasher operations
- Experience supporting equipment/instrument lifecycle management and OOT investigations
- Experience supporting regulatory inspections and maintaining audit readiness
- Proficiency with systems such as LIMS, Smart QC, Excel, and PowerPoint
Nice To Haves
- Prior experience leading sample management or lab support teams
- Project management experience
Responsibilities
- Lead and develop the QC Lab Support team, overseeing hiring, training, performance, and daily operations
- Manage core lab support activities including sample management, stability pulls, equipment cleaning, autoclave/glass wash operations, and lab supply coordination
- Ensure equipment readiness, calibration, lifecycle management, and support OOT investigations
- Maintain GMP compliance, audit readiness, and data integrity across all lab support processes
- Drive deviation investigations, CAPAs, and continuous improvement initiatives
- Optimize and standardize lab support processes, including procedures and training programs
- Partner cross-functionally with QC and manufacturing to align support with testing and production needs
- Manage resources, staffing, and budget to ensure efficient, cost-effective operations
Benefits
- Medical, Dental, Vision, & Life insurances
- Fitness & Wellness programs including a fitness reimbursement
- Short- and Long-Term Disability insurance
- A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
- Up to 12 company paid holidays + 3 paid days off for Personal Significance
- 80 hours of sick time per calendar year
- Paid Maternity and Parental Leave benefit
- 401(k) program participation with company matched contributions
- Employee stock purchase plan
- Tuition reimbursement of up to $10,000 per calendar year
- Employee Resource Groups participation
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What This Job Offers
Job Type
Full-time
Career Level
Manager
