Senior Analytical Project Manager

Debiopharm is an independent biopharmaceutical company based in Switzerland. Mainly active in oncology and infectious diseases, Debiopharm aims to improve patient outcomes and quality of life. Debiopharm Research & Manufacturing SA, based in Martigny, is a pharmaceutical research, development, and manufacturing company equipped with GMP-compliant facilities and certified by major regulatory authorities. As the group's center of expertise in therapeutic chemistry, the company is the world leader in injectable products based on polylactic-co-glycolic acid (PLGA).

To strengthen its "Industrial Transfer" Department, Debiopharm in Martigny is looking for a

SENIOR ANALYTICAL PROJECT MANAGER

Your Mission:

Manage analytical projects within the CMC Industrial Transfer department whose mission is to develop and industrialize pharmaceutical products from the early clinical phases through to commercialization, and to ensure the life cycle management of marketed products through improvement and security projects.

Establish analytical development plans integrating the necessary technical and regulatory requirements according to the development phase and coordinate/supervise activities in accordance with these plans, respecting quality, deadlines, and announced costs.

Your Responsibilities:

• Establish and lead the development strategy of analytical projects within multidisciplinary teams including experts in process development, injection device development, toxicology, etc.
• Supervise the transfer and optimization of analytical methods (liquid chromatography, dissolution tests, etc.) mainly on peptides/formulated peptide-based products, conduct stress and forced degradation tests, robustness tests, and provide support for validation.
• Support the development and validation of manufacturing processes and primary containers, including providing expertise in risk analyses related to these activities.
• Participate in setting specifications for raw materials, intermediates, and finished products.
• Participate in the writing of regulatory dossiers and various CMC documents requiring your expertise.
• Manage analytical activities outsourced to CROs/CDMOs and relationships with these external partners.
• Supervise the qualification of new technologies.
• Implement Analytical Quality By Design (AQBD).

Your Profile:

• PhD in analytical chemistry or equivalent, with a minimum of 5 to 10 years of experience in analytical development, in the pharmaceutical industry or as a project leader in academia. Experience in peptides, particularly on radioligand precursors, would be a plus.
• Previous project management experience, ideally in projects with a matrix organization and in a cGMP environment.
• Very good knowledge of regulatory guidelines related to analytical development.
• Collaborative, proactive mindset, with a desire to always do better. Ability to balance risks associated with a project, especially quality, demonstrating pragmatism and efficiency.
• Ability to synthesize information and communicate it appropriately, both orally and in writing, especially in communication with health authorities.
• Fluency in French and English.