Manager, Quality Control Biochemistry

Role Summary

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.

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

Qualifications

• Bachelor‚Äôs degree in Biochemistry, Chemistry, or related field (Master‚Äôs 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

Skills

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

Education

• Bachelor‚Äôs degree in Biochemistry, Chemistry, or related field (Master‚Äôs preferred)

Additional Requirements

• Onsite position Monday through Friday business hours, with occasional weekend and off-shift support required