Senior CMC Director

A rapidly expanding global biopharmaceutical company is advertising a vacancy for a Senior CMC Director position in their Switzerland office. The organisation is dedicated to being leaders in innovative medicines and vaccines. This is an exciting opportunity to work with a dynamic and innovative company that is rapidly changing the face of the personal healthcare industry.

Job Responsibilities

• Developing detailed pharmaceutical development plans for projects (from the identification of the drug candidate to marketing).
• Defining the studies necessary to make a new chemical entity a finished product accepted in clinical trial and until its approval for marketing, in connection with the various services involved and / or with providers chosen for their expertise.
• Coordinating all the synthesis studies of the active ingredient, analytical, pre-formulation and formulations with our partner providers.
• Managing the production of batches of active ingredient and batches of therapeutic units, ensuring compliance where applicable.
• Guarantee compliance with deadlines for carrying out studies or manufacturing.
• Writing or validate all study reports entering the product file.
• Ensuring that projects are carried out in accordance with protocols, Standard Operating Procedures (SOP), ICH / Good Manufacturing Practices regulations, as well as specific procedures under study.
• Working with the quality department to help identify potential quality problems.
• Participating in the development of processes and SOPs.

Skills and Requirements

• Pharmacist or chemical engineer, ideally you have a specialisation in formulation or process.
• Experienced in leading complex projects in the field of pharmaceutical development, you have a good knowledge of the drug development processes and of all regulatory aspects relating to clinical trials.
• Strong experience with the FDA
• Strong experience with BLA Submissions (hands on, not reviewing and approving)
• Technical Regulatory CMC background
• Excellent understanding of regulatory affairs guidelines
• Strong Biologics / Biosimilars expertise

To Apply

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Keri Marshall at 0207 440 0679 or upload your CV on our website - www.proclinical.com/send-cv

A full job description is available on request.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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