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For our pharmaceutical partner, Gi Life Science is looking for a :

CMC Analytical Development and Drug Product Senior Scientist

(temporary position)

Your mission:

Ensure the analytical and drug product development, manufacturing and controls tailored to the needs of patients

Your responsibilities:

• Establish and implement analytical and drug product development and validation strategies (including Life Cycle Management)
• Define specification and justification for drug product, lead the analytical method development programs, define the stability study strategies (development and ICH studies) and evaluate the data in order to determine a shelf life, lead the evaluation and characterization of impurities
• Lead formulation development programs as well as the production and release of several drug products for late stage clinical trials in coordination with the CMC and wider project teams in line with patients’ needs
• Lead regulatory and control strategies for drug products in line with Quality by Design principles, taking into consideration the status of the project, assessing risks, and ensuring their mitigation
• Develop and maintain suppliers’ platform and experts, while selecting the optimal suppliers for drug product development, manufacturing and controls, negotiating offers and contracts with the support of the Outsourcing Manager
• Act as the main point of contact, manage, challenge, lead analytical and drug product activities performed at CDMO’s/CRO’s, and assure the conformity (scientific and documentary) with external partners
• Preparation, review, archiving of analytical and drug product CMC source documents for clinical trial application (Quality section), acting as a support to CMC Regulatory Affairs

Your profile:

• Master degree or Ph. D. in pharmaceutical sciences
• At least 5 years’ experience in the pharmaceutical industry working in hands-on analytical and drug product development roles on late stage development
• A proven track record in the development of liquid and solid parenteral dosage forms at an industrial level, and/or oral dosage form
• Extensive expertise in pharmaceutical quality control of drug product/drug substance (small molecule, peptide), physico-chemical tests (such as chromatographic methods), microbiological tests
• Solid knowledge of regulatory framework for pharmaceutical drug development and quality guidelines (GMP, Pharmacopeias, ICH, EMA/FDA guidances…) applicable to investigational medicinal products
• Experience in outsourcing and managing a network of suppliers is a plus
• Scientific curiosity, detail-oriented and capable of identifying and solving complex scientific problems
• English and French