Manager, Process Operations

What you'll do

• Lead a team executing upstream and downstream production operations while ensuring daily task accountability.
• Drive cGMP and EHS compliance to maintain a strong safety culture on the manufacturing floor.
• Manage operational readiness activities for the launch of the new GMP facility.
• Coach, develop, and provide performance feedback to direct reports through regular 1:1 meetings.
• Troubleshoot technical issues and make timely decisions regarding production deviations and investigations.
• Author, revise, and approve SOPs, batch records, work instructions, and other technical documentation.
• Oversee production planning and coordinate cross-functional tech transfer programs for new products.
• Support facility start-up activities including equipment qualification and MES implementation.

What we're looking for

• Bachelor’s degree in chemical/biochemical engineering, pharmaceutical sciences, chemistry, biochemistry, biology, microbiology, or related discipline with 5 years experience.
• Master’s degree in a relevant field with at least 3 years of experience.
• Minimum 5 years of experience in a GMP-regulated biologics drug substance manufacturing environment.
• Experience leading operations teams and monitoring performance.
• Working knowledge of cGMP, Quality Systems, EHS requirements, DeltaV, MES, and SAP.
• Experience writing SOPs and technical documents.
• Experience with single-use systems (preferred).
• Experience with facility fit assessments, new product introduction, process transfer, and clinical manufacturing (preferred).