Parenteral Manufacturing Manager

Hobson Prior are currently looking for a Parenteral Manufacturing Manager to join a fantastic pharmaceutical organisation on a contract basis located in Steinhausen. Our client is focused on bettering the lives of patients globally.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• For this role, you will be responsible for managing of 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.
• Support of review of technical documents and data verification activities.
• Providing Impact assessments of change requests in alignment with the respective product owner.

Key Skills:

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

Requirements:

• A Bachelor’s degree in a relevant engineering or science field (chemical/mechanical /bioprocess engineering. biochemistry, pharmacy, microbiology or a related pharmaceutical science) is required.
• A Masters or a 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.
• Experience with formal risk assessment and investigational tools such as pFMEA, Ishikawa Fish Bone.
• 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.
• The ideal candidate will be a subject matter adept in sterile manufacturing processes, with excellent 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.
• 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.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.