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
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 $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.
Top Skills
What We Do
Through cutting-edge science and medicine, Biogen discovers, develops and delivers innovative therapies worldwide for people living with serious neurological and neurodegenerative diseases.
Founded in 1978, Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis. Biogen also manufactures and commercializes biosimilars of advanced biologics.
With approximately 7000 people worldwide, we are truly a global organization, headquartered in Cambridge, Massachusetts, which is also home to our research operations. Our international headquarters are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.
For more information, please visit www.biogen.com. Follow us on social media – Twitter, LinkedIn, Facebook, YouTube.
