QC Manager, Sample and Lab Equipment Management

About This Role

We are seeking an experienced and motivated QC Manager 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 (MondayFriday) with occasional off-shift and weekend support as needed.

What Youll Do

• 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

Who You Are

You are a strategic results-driven leader with strong expertise in GMP quality control operations. You bring a passion for developing teams driving continuous improvement and ensuring high-quality inspection-ready laboratory environments.

Required Skills

• Bachelors 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

Preferred skills

• Prior experience leading sample management or lab support teams
• Project management experience

Additional Information

Base salary offered is determined through an analytical approach utilizing a combination of factors including but not limited to relevant skills & experience job location and internal equity.

Regular employees are eligible to receive both short term and long-term incentives including cash bonus and equity incentive opportunities designed to reward recent achievements and recognize your future potential based on individual business unit and company performance.

In addition to compensation Biogen offers a full and highly competitive range of benefits designed to support our employees and their families physical financial emotional and social well-being; including but not limited to:

• 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 $10000 per calendar year
• Employee Resource Groups participation

Why Biogen

We are a global team with a commitment to excellence and a pioneering spirit. As a mid-sized biotechnology company we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning growth and expanding their skills. Above all we work together to deliver life-changing medicines with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds cultures and perspectives make us a stronger and more innovative company and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about our Biogen.

All qualified applicants will receive consideration for employment without regard to sex gender identity or expression sexual orientation marital status race color national origin ancestry ethnicity religion age veteran status disability genetic information or any other basis protected by federal state or local law. Biogen is an E-Verify Employer in the United States.