Director of cGMP Biopharma Manufacturing & Strategy

Recipharm; Boston (MA); On-site; USD 200,000 - 215,000; Full time

Job summary

Recipharm is seeking an experienced and strategic Director of Manufacturing to lead and continuously improve GMP manufacturing operations in Watertown, MA. This role develops a multi-year manufacturing strategy supporting both clinical and commercial production, including aseptic fill/finish, plasmid, and lipid nanoparticle (LNP) production.

You will build and lead a high-performing cGMP organization, ensure safety, quality, compliance, and operational excellence, and drive readiness,

Qualifications

• Minimum 10 years hands-on cGMP manufacturing experience.
• CDMO experience strongly preferred.
• At least 7 years of progressive leadership in manufacturing or operations.
• Experience supporting both clinical-stage and commercial manufacturing.

Responsibilities

• Develop and execute manufacturing strategies supporting clinical and commercial ops.
• Lead day-to-day cGMP manufacturing activities to meet objectives.
• Build and develop a capable manufacturing workforce.
• Establish and oversee training programs for cGMP operations.
• Drive continuous improvement and KPI implementation.
• Develop and maintain manufacturing documentation (SOPs, batch records).
• Ensure compliance via deviations, investigations, CAPAs, regulatory requirements.
• Provide technical leadership during scale-up, tech transfer, validation, and campaigns.
• Collaborate cross-functionally with Quality, Analytical Development, Supply Chain, Engineering, and Tech Transfer.
• Engage in client meetings and business reviews to support customer relationships.

Skills

cGMP manufacturing

Leadership

Cross-functional collaboration

Process scale-up

Quality & compliance

Validation

Project management

Education

Bachelor's degree in Biology/Biochem/Chemistry/Engineering

MS or equivalent preferred

Job description

Recipharm is seeking an experienced and strategic Director of Manufacturing to lead and continuously improve GMP manufacturing operations in Watertown, MA. This role develops a multi-year manufacturing strategy supporting both clinical and commercial production, including aseptic fill/finish, plasmid, and lipid nanoparticle (LNP) production.

You will build and lead a high-performing cGMP organization, ensure safety, quality, compliance, and operational excellence, and drive readiness,