Parenteral Manufacturing Manager - Contract - Zug

For our client, a global pharmaceutical company, we are looking for a Parenteral Manufacturing Manager to support commercial manufacturing of drug product.

The contract will be for 9-12 months based in Zug, Switzerland


Main responsibilities

  • Managing manufacturing or complaint investigations that involve potential product impact, including root cause analysis, CAPA generation, and impact assessment

  • Support of process capability analysis and Continuous Process Verification of key quality attributes and parameters at the CMO.

  • Providing Impact assessments of change requests in alignment with the respective product owner

  • Support review of technical documents and data verification activities

Required competencies and experience

  • Subject matter expert in sterile manufacturing processes, with a strong knowledge of global regulatory requirements (e.g. FDA) related to the design and control of these processes.

  • Technical knowledge of sterile manufacturing technology and processing techniques.

  • Experience as deviation investigator, GMP change management and complaint investigations.

  • Experience and knowledge of SOPs, cGMPs and GLPs and the know how to work and manage within a regulatory environment.

  • Strong technical writing skills (English).

  • Ability to work within and lead cross-functional technical teams, across multiple cultures.

  • Statistical analysis capability, including use of statistical software platforms (e.g. Minitab, J M P) to determine trends and variability across inter-batch data sets.

  • Experience with formal risk assessment and investigational tools such as pFMEA, Ishikawa Fish Bone.

  • Strong communication skills, both oral and written (English).

Required qualification(s)

  • Bachelor's degree in relevant engineering or science discipline (chemical/mechanical /bioprocess engineering. biochemistry, pharmacy, microbiology or a related pharmaceutical science) is required. Masters or PhD level degree is strongly preferred.

  • Minimum of 6 years of experience as a BS degree, 4 years of experience as a MS degree and 2 years of experience as a PhD is required.



To apply or for further information please email recruitment@consultantsinscience.com