Manager/Senior Manager - Gene Therapy, GMP Downstream

GMP Downstream Team Lead (Manager/Senior Manager)

Job Summary:
We are seeking an experienced GMP Downstream Team Lead (Manager/Senior Manager) to lead downstream operations in Cell and Gene Therapy manufacturing. This role requires expertise in filtration, chromatography, and purification techniques, combined with strong leadership skills to oversee downstream processing, compliance, and continuous improvement initiatives. The successful candidate will drive operational excellence, ensuring efficiency and adherence to GMP regulations.

Key Responsibilities:

• Lead the downstream manufacturing team, ensuring smooth execution of purification processes, filtration, and chromatography.
• Oversee the end-to-end downstream process, ensuring compliance with cGMP, SOPs, and batch documentation.
• Develop and optimize downstream purification strategies for process efficiency and scalability.
• Work closely with Process Development, Quality, and Engineering teams to ensure seamless technology transfer.
• Take ownership of investigations, deviations, CAPAs, and regulatory compliance audits.
• Implement continuous improvement initiatives to enhance downstream process performance.
• Ensure team readiness for Regulatory Authority inspections and GMP compliance audits.
• Manage equipment qualification and periodic validation in collaboration with QA and Engineering teams.
• Provide technical leadership and training to downstream manufacturing staff.
• Drive collaboration across functions, participating in process-related and strategic meetings.

Experience and Knowledge:

• 9-12 years of experience in a cGMP biopharmaceutical or cell/gene therapy manufacturing environment.
• Expertise in chromatography, filtration, and other purification techniques.
• Hands-on experience in plasmid, viral vector, or biologics GMP downstream manufacturing.
• Strong understanding of FDA, EMA, and ICH regulatory guidelines.
• Proven ability to lead teams and manage downstream production operations in a cleanroom.
• Excellent communication, problem-solving, and cross-functional collaboration skills.

Qualifications:

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