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 (Monday–Friday) with occasional off-shift and weekend support as needed.

What You’ll 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

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

Preferred skills

Prior experience leading sample management or lab support teams

Project management experience

Job Level: Management

Additional Information

The base compensation range for this role is: $111,000.00-$149,000.00

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 $10,000 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 on  to 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.