Senior Manager– Manufacturing Operations (Biologics & Gene Therapy)

JOB DESCRIPTION

Job title : Senior Manager– Manufacturing Operations (Biologics &Gene Therapy)

Reports to : VP - Operations

Job purpose

We are seeking an experienced and highly motivated Senior Manager – Manufacturing Operations to support development activities for gene therapy and biologics programs. The role will oversee CMC manufacturing operations across process development, technology transfer, GMP manufacturing.

The ideal candidate will bring strong expertise in biologics and advanced therapy manufacturing, including viral vectors, cell culture operations, downstream processing, and GMP compliance. This individual will collaborate closely with Quality, Regulatory, Process Development, MSAT, and external CDMO partners to ensure timely and compliant execution of manufacturing strategies.

Duties and responsibilities

• Manage upstream and downstream manufacturing operations including viral vector production, biologics processing, purification, formulation, and fill-finish coordination.
• Oversee technology transfer activities between development, manufacturing sites, and CDMOs.
• Ensure GMP-compliant manufacturing execution and adherence to regulatory expectations including FDA, EMA, and ICH guidelines.
• Coordinate batch manufacturing schedules, material readiness, production documentation, and deviation management.
• Collaborate with QA, QC, Regulatory Affairs, Supply Chain, and Process
• Review and approve batch records, SOPs, protocols, change controls, CAPAs, and technical reports.
• Drive process optimization, manufacturing efficiency improvements, and operational excellence initiatives.
• Support regulatory submissions including IND, BLA, and CMC documentation preparation.
• Monitor manufacturing KPIs, production timelines, and risk mitigation strategies.
• Manage external manufacturing partners and ensure deliverables meet quality and timeline expectations.
• Manage manufacturing CMC activities for gene therapy and biologics programs from clinical through commercial stages.
• Mentor and guide junior manufacturing and technical operations staff.

Qualifications and Experience

• Master’s, or PhD in Biotechnology, Biochemical Engineering, Life Sciences, or related discipline.
• 12 to 15 years of experience in biologics, cell & gene therapy, or biopharmaceutical manufacturing process.
• Strong understanding of CMC development and GMP manufacturing requirements.
• Hands-on experience with viral vectors (AAV, Adenovirus), mammalian cell culture, purification systems, and aseptic processing preferred.
• Experience managing CDMOs and technology transfer activities.
• Knowledge of regulatory requirements for biologics and gene therapy products.
• Familiarity with single-use systems, cleanroom operations, and manufacturing scale-up.
• Strong leadership, project management, and cross-functional collaboration skills.
• Excellent communication and technical documentation abilities.

Preferred Skills

• Experience supporting late-stage clinical development programs.
• Exposure to digital manufacturing systems, MES, or electronic batch records.
• Lean manufacturing or operational excellence experience.
• PMP or Six Sigma certification is a plus.

Working conditions

This position operates in an office setting,in person.

Job may additionally require incumbent to be available outside of these hours to handle priority business needs.

Direct Reports

N/A