Manager/Senior Manager - Gene Therapy, GMP Upstream

GMP Upstream Team Lead (Manager/Senior Manager)

Job Summary:
We are seeking a highly experienced GMP Upstream Team Lead (Manager/Senior Manager) to oversee the upstream operations for Cell and Gene Therapy manufacturing. This role requires a strong leader with deep expertise in fermentation, cell culture, and bioreactor operations within a cGMP environment. The successful candidate will be responsible for leading a team, optimizing processes, ensuring regulatory compliance, and driving continuous improvement within the upstream manufacturing function.

Key Responsibilities:

• Lead and manage the upstream manufacturing team, providing guidance, mentorship, and technical expertise.
• Oversee end-to-end upstream operations, including fermentation, cell culture, and bioreactor management (50-500L scale).
• Develop and implement strategies for process optimization and scalability to enhance production efficiency.
• Ensure strict adherence to cGMP regulations, SOPs, and batch record documentation.
• Collaborate with Process Development, Quality, and Engineering teams to bring manufacturing processes into GMP compliance.
• Lead technology transfer initiatives for new product introductions and process scale-ups.
• Identify and implement continuous improvement initiatives, leveraging lean manufacturing principles.
• Take ownership of deviation investigations, CAPAs, and regulatory audit readiness.
• Drive cross-functional engagement by participating in technical and regulatory meetings.
• Manage resources effectively, including personnel scheduling, equipment readiness, and material availability.
• Support training and development programs to enhance the technical capabilities of the upstream team.

Experience and Knowledge:

• 9-12 years of experience in a cGMP biopharmaceutical or cell/gene therapy environment.
• Proven expertise in fermentation, cell culture, bioreactor operations, and aseptic processing.
• Hands-on experience in plasmid, viral vector, or biologics GMP upstream manufacturing.
• Strong knowledge of regulatory requirements (FDA, EMA, ICH guidelines).
• Experience in leading teams and managing manufacturing operations in a cleanroom setting.
• Excellent problem-solving, decision-making, and project management skills.
• Strong interpersonal skills with the ability to work cross-functionally.

Qualifications:

• BSc/MSc in Life Sciences, Biological/Chemical Engineering, or related field.
• Demonstrated leadership in a GMP manufacturing environment.
• Prior experience in managing teams and overseeing production activities in a regulated setting.