Associate Director, Process Engineer

Role Summary

Associate Director, Process Engineer oversees drug product manufacturing activities at contract manufacturing organizations (CMOs) from clinical phase through commercial production. The role requires expertise in parenteral drug manufacturing, aseptic process validation, technology transfer, process development, and change management, coordinating multiple projects across CMO locations. Location: Minneapolis, MN (remote) near CMOs or Cary, NC (hybrid).

Responsibilities

• Direct, oversee, and/or develop drug product manufacturing processes at CMOs in support of clinical phase through commercial production. Act as company liaison, including person in plant, for activities at CMO sites.
• Collaborate with internal Quality Assurance, Quality Control, Regulatory Affairs and Supply Chain teams to align on company product development and production goals.
• Collaborate with Quality organizations to assure cGMP standards and agreed upon Quality performance/improvement deliverables are achieved.
• Define development pathway for CMO activities to meet corporate goals. Develop contingency plans and/or risk mitigation strategies and allocate resources as appropriate to ensure project milestones are achieved.
• Author and/or review internal and CMO documents as the manufacturing subject matter expert for protocols, reports, master batch records and other relevant documents.
• Responsible for manufacturing process development, implementation, and continuous improvement to improve efficiency and achieve consistent process performance. Manage process validations (IQ/OQ/PQ) at CMO.
• Prepare performance objectives and metrics for supplier and company. Monitor and report on process trends of important performance indicators.
• Deliver frequent verbal and/or written communications for internal meetings and external collaborators.

Qualifications

• Experience in management of drug product production techniques and processing at CMO sites. Proficiency with aseptic drug product techniques to produce sterile products in vials and pre-filled syringes is highly desired.
• Strong knowledge and demonstrated practice of relevant ICH, cGMP, and ISO guidelines.
• Detail-oriented with strong written and oral communication skills.
• Thrives working with others in a multidisciplinary team environment.
• Ability to independently troubleshoot problems and design, develop, and execute projects with minimal supervision.

Education

• Degree in Biology, Pharmacy, Chemistry or Engineering (Chemical or Mechanical): Bachelor's / Master's degree with 10+ years of experience or PhD degree with 8+ years of experience.

Additional Requirements

• Travel 15 – 40% within and outside of the USA, as required to meet project objectives.