Technical Operations Manager MSAT

Technical Operations Manager (MSAT) (w/m/d)

Location: Basel City (Hybrid)

Start date: Immediately

Duration: 6 months + permanent position

Key Responsibilities:

• Manage daily technical activities related to manufacturing and quality control of pharmaceutical products, including technology transfer, analytical topics, manufacturing processes, quality control investigations, and troubleshooting.
• Author, review, and approve technical and GxP documents (protocols, reports, instructions) to ensure compliance with cGMP, QA, and regulatory standards.
• Oversee MSAT-related Change Controls.
• Provide expertise in GxP, Quality Control, and pharmaceutical manufacturing.
• Offer technical support to internal stakeholders, such as Regulatory Affairs and Quality Assurance, including handling questions from authorities, deviations, investigations, and risk assessments.
• Assess, interpret, and provide guidance on analytical methods and techniques related to APIs or finished products (e.g., HPLC, endotoxins, sterility).
• Act as CMC expert support for requests from Regulatory Affairs.
• Facilitate technical exchanges and follow-ups with external partners (CMOs, Analytical labs, API suppliers).
• Occasionally back-up MSAT project follow-up.
• Collaborate with Project Management to ensure proper archiving and classification of MSAT-related documents.
• Participate in routine Quality Control activities, including global management of reference standards and ongoing stability studies.

Requirements:

• University degree (Master's) in Life Sciences (e.g., chemistry, pharmacy, biotechnology).
• Work experience and knowledge of GMP pharmaceutical manufacturing and Quality Control, with insights into regulatory and quality areas.
• A minimum of 5 years of experience in an operational GMP pharmaceutical environment, with expertise in manufacturing finished products (oral forms, injectables) and analytical techniques.
• Strong understanding and mastery of GMP and other pharmaceutical guidelines.
• Proactive, autonomous, and flexible approach within field responsibilities.
• Ability to respect cultural differences and sensitivities, and to develop strong relationships with diverse stakeholders.
• Willingness to travel (up to 10%).
• Proficiency in IT tools, including MS Office, MS Projects, and other project management software.
• Fluency in English required; proficiency in French and/or German highly desired

In Switzerland, for contract roles it is mandatory for the candidate to be a Swiss citizen or a European passport holder!

Sthree Switzerland is acting as an Employment Business in relation to this vacancy.