As Pharmaceutical Operations Manager in the Manufacturing Science and Technology department (MSAT), you will contribute to the MSAT team at the Basel site and report to the Head of MSAT. In this role, you will manage various technical and analytical aspects related to the manufacturing and quality control of our portfolio of pharmaceutical products.
Key Responsibilities
• Manage daily technical aspects and activities related to manufacturing and quality control of our pharmaceutical products (e.g., technology transfer topics, analytical topics, manufacturing process, Quality Control investigation, and troubleshooting, etc.).
• Regularly write, review, and approve technical (manufacturing/quality control) and GxP documents (e.g., protocols, reports, and instructions) to ensure cGMP, QA, and regulatory compliance at all times.
• Management of MSAT-related Change Controls.
• Provide expertise on GxP, Quality Control, and pharmaceutical manufacturing matters.
• Provide technical (manufacturing and Quality Control) support to internal stakeholders, mainly Regulatory Affairs and Quality Assurance (e.g., questions from authorities, deviations, investigations, risk assessments).
• Assess, interpret, and give guidance (internally/externally) on analytical methods and techniques related to APIs or finished products (e.g., HPLC, endotoxins, sterility, or other analytical methods).
• Act as CMC expert support (manufacturing and Quality Control) on punctual requests coming from Regulatory Affairs.
• Assure technical exchanges and follow-ups with our different external partners (CMOs, Analytical labs, API suppliers).
• On punctual occasions, back-up MSAT projects follow-up.
• In collaboration with the Project Management function, ensure the archiving and classification of MSAT-related documents (paper-based or electronic).
• Participate in the routine follow-up of Quality Control activities, such as global management of reference standards and ongoing stability studies.
Your Profile
• University degree – Master’s in Life Sciences (e.g., pharmacy, pharmaceutical sciences, chemistry, biotechnology, etc.).
• Work experience and knowledge of GMP pharmaceutical manufacturing, with a strong awareness of quality assurance aspects. Quality control experience is a valuable complementary asset.
• At least 5 years of proven experience in an operational GMP pharmaceutical environment with combined expertise in manufacturing finished products (oral forms, injectables) and analytical expertise is mandatory.
• Practical experience in managing QA documents (CCs, CAPAs, investigations, etc.) derived from operational activities.
• The successful candidate must propose significant proactivity, autonomy, anticipation, and flexibility within their field of responsibilities.
• Respecting cultural differences and sensitivities and developing good relationships with stakeholders of different backgrounds is a must.
• Ability to work on several projects simultaneously: analytical thinking and organization skills are part of your key strengths.
• You are ready to travel (approximately 5–10% of the time).
• You have an excellent command of IT tools, including MS Office, MS Projects, and other project management tools.
• You have a high degree of relational and professional ethics and integrity.