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Biogen

Manager, Quality Control Biochemistry

Biogen, Durham, North Carolina, United States, 27703

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This is an onsite position Monday through Friday business hours, with occasional weekend and off-shift support required

About This Role The Biochemistry Manager will lead the Biochemistry function at our biologics drug substance manufacturing facility with a team of direct reports. This role is essential for overseeing release and stability testing, as well as supporting analytical method transfer and validation activities.

What You’ll Do

Lead and manage the site Biochemistry team, including hiring, training, and performance management

Provide expert technical guidance and mentorship, supporting investigations, analytical method validation, and process improvements in QC Biochemistry

Ensure compliance with Biogen policies, regulatory requirements, and industry standards, maintaining effective laboratory systems and supporting regulatory submissions

Serve as the subject matter expert (SME) for Biochemistry during regulatory inspections and audits

Drive continuous improvement initiatives

Support budget adherence and resource allocation, identifying and addressing variances as needed

Represent the department in cross-functional and regulatory interactions, supporting strategic initiatives and harmonization of procedures and methods

Who You Are A confident leader who inspires and develops high-performing teams. Detail-oriented and analytical, with a strong commitment to data integrity and quality. Passionate about continuous improvement and innovation. Resilient and adaptable, with a proactive approach to problem-solving and risk management.

Required Skills

Bachelor’s degree in Biochemistry, Chemistry, or related field (Master’s preferred)

Minimum 5 years of experience in QC Biochemistry laboratories within a GMP regulated biologics or pharmaceutical manufacturing environment

Minimum 2 years of supervisory experience

Expertise in analytical methods (electrophoresis, protein characterization and chromatography) including: SDS-PAGE, Gel chip, Capillary electrophoresis, icIEF, SEC, SEC-UPLC, RP-HPLC, IEX, ELSD and BDCA Glycan

Experience with regulatory inspections and audit readiness

Proven leadership and team management skills

Excellent communication, problem-solving, and organizational abilities.

Proficiency with business technology tools and data systems (e.g., LIMS, Smart QC, Empower, Excel, PowerPoint, etc.)

Strong verbal and written communication skills, with meticulous attention to detail

Willingness and ability to work additional hours as needed to meet department and business needs

Preferred Skills

Project Management experience

Experience with the following testing: osmolality, pH, refractive index, functionality, particulate, UV Spectroscopy, SoloVPE, Titer, Poly Analysis

Job Level: Management

Additional Information The base compensation range for this role is: $109,000.00-$146,000.00

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 planTuition 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 DE&I efforts.

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.

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