Director, Manufacturing

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 is seeking an experienced and strategic Director of Manufacturing to lead and continuously improve our GMP manufacturing operations in Watertown, MA. This role is responsible for developing and executing a multi-year manufacturing strategy that supports both clinical and commercial production capabilities, including aseptic fill/finish, plasmid manufacturing, and lipid nanoparticle (LNP) production. The Director of Manufacturing will build, lead, and develop a high-performing cGMP manufacturing organization while ensuring the highest standards of safety, quality, compliance, and operational excellence. This position plays a critical leadership role in driving manufacturing readiness, operational efficiency, and successful customer outcomes.

Essential Job Functions

• Develop and execute manufacturing strategies that support current and future clinical and commercial operations.
• Lead and manage day-to-day cGMP manufacturing activities to ensure departmental objectives, production schedules, and company goals are achieved.
• Build, develop, and maintain a highly capable manufacturing workforce through recruitment, training, coaching, and performance management.
• Establish and oversee robust manufacturing training programs to ensure personnel are qualified to perform cGMP operations.
• Drive operational excellence through continuous improvement initiatives, process optimization, and implementation of key performance indicators (KPIs).
• Lead the development and maintenance of manufacturing documentation, including SOPs, batch records, and operational procedures.
• Ensure compliance through effective management of deviations, investigations, CAPAs, and regulatory requirements.
• Provide technical leadership during process scale-up, technology transfers, process validation, equipment implementation, and manufacturing campaigns.
• Partner cross-functionally with Quality, Analytical Development, Supply Chain, Engineering, and Technical Transfer teams to ensure operational readiness and successful manufacturing execution.
• Participate in client meetings, technical discussions, and business reviews while supporting strong customer relationships and project success.

Experience and Skills

Education

• Bachelor's degree in Biology, Biochemistry, Chemistry, Engineering, or a related scientific discipline required.
• Advanced degree (M.S. or equivalent) preferred.

Experience

• Minimum 10 years of hands-on experience in cGMP manufacturing within the biopharmaceutical, biotechnology, or pharmaceutical industry.
• Prior experience working within a CDMO environment is highly preferred.
• At least 7 years of progressive leadership experience managing manufacturing or operations teams in a regulated cGMP environment.
• Experience supporting both clinical-stage and commercial manufacturing operations is strongly preferred.

Skills

• Strong knowledge of cGMP regulations and manufacturing best practices.
• Proven ability to lead and influence cross-functional teams and drive organizational performance.
• Demonstrated experience managing complex manufacturing operations and implementing continuous improvement initiatives.
• Excellent problem-solving, investigation, and decision-making capabilities.
• Ability to balance strategic planning with hands-on operational execution.
• Strong leadership, communication, and interpersonal skills with the ability to effectively interact with clients, regulators, and internal stakeholders.
• High sense of urgency, accountability, and commitment to delivering results.

Physical Demands

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the position.

• Frequently required to stand, sit, use hands, reach, communicate, and operate standard office and manufacturing equipment.
• Occasionally required to walk, climb, balance, stoop, kneel, crouch, or crawl.
• Must be able to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds.
• Requires close vision and the ability to adjust focus while working in manufacturing and office environments.
• Ability to work within a cGMP manufacturing environment, including cleanroom settings.
• Occasional travel (less than 10%) may be required to support training or project activities.

Annual Base Salary Range $200,000 to $215,000