Plant Manager

52602
  • Hanau, Germany
  • Permanent

Plant Manager (API Manufacturing)

Location: Hanau Area, Germany
Industry: Pharmaceutical API CDMO

About the Role

We are seeking a motivated and hands-on Plant Manager to join a growing API  CDMO based in the Hanau area. This is an excellent opportunity for an experienced professional to play a key role in establishing and developing manufacturing operations within a dynamic and expanding organization.

The successful candidate will oversee day-to-day plant operations while supporting process optimization, technology transfer, and team development to ensure safe, compliant, and efficient API manufacturing.

Key Responsibilities

  • Manage daily manufacturing operations for API production, ensuring compliance with GMP, safety, quality, and production targets.
  • Lead and support technology transfer activities from development into commercial manufacturing.
  • Drive process development and continuous process improvement initiatives.
  • Review, create, and maintain GMP batch records and manufacturing documentation.
  • Collaborate closely with Process Development, Quality, Engineering, and Supply Chain teams to ensure smooth production execution.
  • Monitor production performance and implement corrective and preventive actions where required.
  • Support equipment qualification, process validation, and scale-up activities.
  • Mentor and develop production staff, fostering a collaborative and high-performance culture.
  • Ensure compliance with regulatory and environmental health & safety requirements.
  • Contribute to the successful growth of a new API manufacturing facility.

Requirements

  • Bachelor's or Master's degree in Chemical Engineering, Chemistry, Pharmaceutical Engineering, or a related scientific discipline.
  • 5–6 years of experience in pharmaceutical API manufacturing, chemical production, or a related process manufacturing environment.
  • Experience with technology transfer in a GMP-regulated environment.
  • Strong background in process development and process optimization.
  • Experience preparing, reviewing, or managing GMP batch records and manufacturing documentation.
  • Previous experience mentoring, supervising, or leading production teams.
  • Good understanding of GMP regulations and pharmaceutical manufacturing processes.
  • Strong problem-solving skills with a proactive, hands-on approach.
  • German language skills at B2 level or above and good English communication skills.

Apply For This Role