Director, Manufacturing

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

Job Summary

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, 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

• 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

Recipharm is a leading Contract Development and Manufacturing Organisation (CDMO) employing over 4,500 employees worldwide. Recipharm provides manufacturing services of pharmaceuticals in various dosage forms, including, sterile fill & finish, oral solid dosage and biologics; clinical trial material development and manufacturing services; and, pharmaceutical product development. Its biologics segment, ReciBioPharm, works with customers to develop and commercialise advanced therapy medicinal products (ATMPs): pre-clinical to clinical and commercial development and manufacture for new biological modalities, encompassing technologies based on live viruses and viral vectors, live-microbial biopharmaceutical products, nucleic acid-based mRNA and plasmid DNA production.

Recipharm manufactures several hundred different products to customers ranging from big pharma to smaller research and development companies. It operates development and manufacturing facilities in France, Germany, India, Italy, Portugal, Spain, Sweden and the US and is headquartered in Stockholm, Sweden.

For more information on Recipharm and our services, please visit www.recipharm.com and www.recibiopharm.com