CMC Analytical Development and Drug Product Senior Scientist - Consultant, 6 mth

工作内容

Debiopharmis an independent biopharmaceutical company based in Switzerland with an ongoing commitment to research in oncology and infectious diseases in order to improve patient outcomes and quality of life. Our main activities include drug development, drug manufacturing and digital health investment. Debiopharm International SA aims to develop innovative therapies that target high unmet medical needs. Our unique “development only” business model allows us to act as a bridge between disruptive discovery products and patient access in international markets. We first identify high-potential compounds for in-licensing, clinically demonstrate their safety and efficacy and then select large pharmaceutical commercialization partners to maximize patient access globally.At Debiopharm you will be at the forefront of the fight against cancer and infectious diseases, and you will have the opportunity to work on new innovative medicines for patients. Efficiency is our mode of action, saving lives our collective target.Here: https://apply.workable.com/debiopharm-group-sa/For our Pharma Development – R&D organization based at our Headquarters in Lausanne, we are looking for aCMC Analytical Development and Drug Product Senior Scientist – Consultant, 6 monthsMission:Bring a high value contribution to the Pharmaceutical Development department and teams to ensure the analytical and drug product development, manufacturing and controls tailored to the needs of patients, while guaranteeing a supportive quality documentation and an industrialisation process in conformity with the development status of the projects.Your responsibilities will be but not limited to:

• Establish and implement analytical and drug product development and validation strategies (including Life Cycle Management);
• Define specification and justification thereof 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, and ensuring an efficient business continuity management;
• 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

RequirementsYour profile:

• Master degree or Ph. D. in pharmaceutical sciences, or equivalent by experience
• 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
• Strong team spirit and ability to collaborate in a matrix organization;
• Fluent in English and ideally a good knowledge in French.

BenefitsDebiopharm offers employees:

• International, highly dynamic environment with a long term vision
• Cross-functional collaboration at the forefront of the most advanced scientific developments in oncology and anti-bacterial industry
• Exposure to a wide variety of areas and functions within clinical development and the pharmaceutical industry
• Participation in a company where innovation, people and entrepreneurship are the fundamental keys to success
• Proud to be an Equal-Pay certified, we ensure offering to all our employees the same opportunities

The use of external staffing agencies or recruiters requires prior approval from our Human Resources Department. The Human Resources Department at Debiopharm requests external staffing agencies or recruiters not to contact Debiopharm employees or members of the Board of Directors directly in an attempt to present candidates.Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the external staffing agency or recruiter does not create any implied obligation on the part of Debiopharm.Debiopharm will not accept unsolicited resumes from any source other than candidates themselves for either current or future positions.