Technical Operations Manager

Vor 5 Tagen

Basel, Schweiz Eumedica Pharmaceuticals AG Vollzeit

EUMEDICA Pharmaceuticals AG is an independent and privately owned pharmaceutical company founded in 1986 in the heart of Basel, Switzerland.

Our responsibility is to ensure continuity of access to patients and healthcare professionals to our unique and targeted therapeutic solutions portfolio.

We focus on niche, severe pathologies, and therapeutic solutions.

Our product portfolio mainly focuses on anti-infectives, gastroenterology, antipsychotics, cardiovascular disorders and hematology, anesthesiology, and pain management.

Technical Operations Manager

As Technical 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

  1. Management on a daily basis of technical aspects and activities in relation to manufacturing and quality control of our pharmaceutical products (e.g., technology transfer topics, analytical topics, manufacturing process, Quality Control investigation, and troubleshooting, etc.).
  2. 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.
  3. Management of MSAT-related Change Controls.
  4. Provide expertise on GxP, Quality Control, and pharmaceutical manufacturing matters.
  5. 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).
  6. 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).
  7. Act as CMC expert support (manufacturing and Quality Control) on punctual requests coming from Regulatory Affairs.
  8. Assure technical exchanges and follow-ups with our different external partners (CMOs, Analytical labs, API suppliers).
  9. On punctual occasions, back-up MSAT project follow-up.
  10. In collaboration with the Project Management function, ensure the archiving and classification of MSAT-related documents (paper-based or electronic).
  11. Participate in the routine follow-up of Quality Control activities, such as global management of reference standards and ongoing stability studies.

Your Profile

  1. University degree - Master in Life Sciences (e.g., chemistry, pharmacy, biotechnology, etc.).
  2. Work experience, knowledge of GMP pharmaceutical manufacturing and Quality Control, and insights into regulatory and quality areas.
  3. 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.
  4. Strong understanding and mastering of GMP and other pharmaceutical guidelines is essential for the position.
  5. The successful candidate must propose significant proactivity, autonomy, anticipation, and flexibility within their field of responsibilities.
  6. Respecting cultural differences and sensitivities and developing good relationships with stakeholders of different backgrounds is a must.
  7. Ability to work on several projects simultaneously: analytical thinking and organization skills are part of your key strengths.
  8. You are ready to travel (up to +/- 10% travel time).
  9. You have an excellent command of IT tools, including MS Office, MS Projects, and other project management tools.
  10. You have a high degree of relational and professional ethics and integrity.
  11. English is a must, French and/or German are highly desired, and any other language is a plus.

We Offer

·A unique opportunity to work daily with highly experienced individuals/teams in a fast-deciding company.

·Being in a determinant position to advance strategic company interests.

·Competitive remuneration according to your competencies and commitment.

·A dynamic and modern work environment aimed at promoting work-life balance.

Ready to take on a new challenge? Then please send your application to jobs@eumedica.ch. We look forward to meeting you soon Please note that we will only contact short-listed candidates.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Management and Manufacturing

Industries

Pharmaceutical Manufacturing

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