Manager, Quality Control Biochemistry

Biogen Idec • Research Triangle Park, NC

66d • $109,000 - $146,000

About The Position

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.

Requirements

• 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

Nice To Haves

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

Responsibilities

• 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

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

What This Job Offers

• Job Type: Full-time
• Career Level: Manager
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees