Debiopharm is an independent biopharmaceutical company based in Switzerland with a long-standing commitment to research in oncology and infectious diseases with the ultimate goal of improving patient outcomes and quality of life. Our main activities include drug development, manufacturing and digital health investment.
Our mission is to develop innovative therapies that target high unmet medical needs by identifying high-potential compounds for in-licensing, clinically demonstrating their safety and efficacy and then partnering with large pharmaceutical companies to maximize patient access globally.
About Debiopharm
We are at the forefront of the fight against cancer and infectious diseases, working on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target.
Job Description
We are looking for a CMC Analytical Development and Drug Product Senior Scientist to bring a high value contribution to our Pharmaceutical Development department and teams.
Responsibilities
1. Establish and implement analytical and drug product development and validation strategies (including Life Cycle Management);
2. Define specifications and justification thereof for drug product, lead analytical method development programs, define stability study strategies and evaluate data to determine shelf life;
3. Lead formulation development programs and production and release of drug products for late stage clinical trials in coordination with CMC and wider project teams;
4. Develop and maintain suppliers' platform and experts while selecting optimal suppliers for drug product development, manufacturing and controls;
5. Act as main point of contact and manage, challenge, lead analytical and drug product activities performed at CDMOs / CROs;
6. Preparation, review and archiving of analytical and drug product CMC source documents for clinical trial application (Quality section).
Your Profile
1. Master degree or Ph.D. in pharmaceutical sciences or equivalent experience;
2. At least 5 years' experience in pharmaceutical industry working in hands-on analytical and drug product development roles on late stage development;
3. A proven track record in development of liquid and solid parenteral dosage forms at industrial level and/or oral dosage form;
4. Extensive expertise in pharmaceutical quality control of drug product/drug substance (small molecule, peptide), physico-chemical tests and microbiological tests;
5. Solid knowledge of regulatory framework for pharmaceutical drug development and quality guidelines (GMP, Pharmacopeias, ICH, EMA/FDA guidances...)
6. Experience in outsourcing and managing network of suppliers is a plus;
7. Scientific curiosity, detail-oriented and capable of identifying and solving complex scientific problems;
8. Strong team spirit and ability to collaborate in matrix organization;
9. Fluent in English and ideally good knowledge in French.
What We Offer
1. International, highly dynamic environment with long-term vision;
2. Cross-functional collaboration at forefront of most advanced scientific developments in oncology and anti-bacterial industry;
3. Exposure to wide variety of areas and functions within clinical development and pharmaceutical industry;
4. Participation in company where innovation, people and entrepreneurship are fundamental keys to success;
5. Proud to be Equal-Pay certified, ensuring same opportunities for all employees.