Manufacturing Director, Biopharma Ops & Strategy

Recipharm; Northern (KY); Hybrid; USD 200,000 - 215,000; Full time

Job summary

Recipharm in Watertown, MA is seeking an experienced Director of Manufacturing to lead our GMP manufacturing operations, spanning aseptic fill/finish, plasmid, and LNP production. You will develop and execute a multi-year strategy to support both clinical and commercial production while building a high-performing cGMP organization.

You will drive operational readiness, respond to regulatory demands, implement KPI-driven improvements, and mentor a cross-functional team across Quality, Analytical

Qualifications

• Bachelor's degree in Biology, Biochemistry, Chemistry, Engineering, or related field.
• Advanced degree (M.S. or equivalent) preferred.
• Minimum 10 years hands-on cGMP manufacturing experience.
• CDMO experience is highly preferred.
• At least 7 years of progressive leadership in manufacturing/operations.
• Experience supporting both clinical-stage and commercial manufacturing.

Responsibilities

• Develop and execute manufacturing strategies supporting clinical and commercial operations.
• Lead day-to-day cGMP manufacturing activities to meet objectives.
• Build and develop manufacturing workforce through recruitment, training, coaching, performance management.
• Establish and oversee robust training programs for cGMP operations.
• Drive operational excellence via continuous improvement and KPI implementation.
• Lead development and maintenance of manufacturing documentation (SOPs, batch records).
• Ensure compliance through management of deviations, investigations, CAPAs, regulatory requirements.
• Provide technical leadership during process scale-up, tech transfers, validation, equipment implementation, campaigns.
• Partner with Quality, Analytical Development, Supply Chain, Engineering, Technical Transfer to ensure readiness.
• Participate in client meetings and business reviews to support customer relationships.

Skills

cGMP knowledge

Cross-functional leadership

Process scale-up

Continuous improvement

Problem solving

Regulatory interaction

Leadership

Education

Bachelor's degree in Biology, Biochemistry, Chemistry, Engineering, or related scientific discipline

Advanced degree (M.S. or equivalent) preferred

Job description

Recipharm in Watertown, MA is seeking an experienced Director of Manufacturing to lead our GMP manufacturing operations, spanning aseptic fill/finish, plasmid, and LNP production. You will develop and execute a multi-year strategy to support both clinical and commercial production while building a high-performing cGMP organization.

You will drive operational readiness, respond to regulatory demands, implement KPI-driven improvements, and mentor a cross-functional team across Quality, Analytical