Senior Scientist, Analytical Development and Quality Control
Debiopharm Group, Switzerland

Debiopharm Group (Debiopharm) is a Swiss-based biopharmaceutical group of four companies active in drug development, GMP manufacturing of proprietary drugs, diagnostics, and investments. Debiopharm International SA searches, evaluates and in-licenses promising drug candidates for development. Towards the end of the development process, the products are licensed out to pharmaceutical companies for world-wide marketing and sales.

For our Pharmaceutical Development organization based at our Headquater in Lausanne, we are looking for a

Senior Scientist, Analytical Development and Quality Control (100%)

The successful candidate will be responsible for the analytical development strategy and will lead the analytical development activities within the CMC development team on a project basis. This results in gaining drug substance and drug product understanding, development of the analytical control and stability strategy, and delivery of the necessary source documents to support the Quality dossier (IMPD, NDA, IND and MAA filings).

You will be responsible for the analytical development strategy for drug substance and drug product and execution thereof according to the CMC plan (from drug substance characterization through formulation and process development and regulatory submissions) for various development projects (small molecules, biopharmaceutical, radiopharmaceutical products).

Your responsibilities

Your responsibilities include, but are not limited to:

• Analytical method development and validation for drug substance and drug product analysis (non GMP and GMP)
• Stability studies and shelf life determination of drug substance and drug product (development and ICH studies), evaluation and characterization of impurities
• Specification development and justification thereof for drug substance and drug product
• Reviewing of QC data package of GMP drug substance and drug product batches to support their release for use in clinical trials
• Preparation, review, archiving of analytical CMC source documents (development and stability reports, analytical validation protocols and reports, operating procedure, Certificate of Analysis, justification of specification and retest dates, etc) for clinical trial application (Quality section), acting as a support to CMC Regulatory Affairs
• Implementing the analytical strategies at CDMO’s/CRO’s, act as the main point of contact, manage, challenge and lead activities with external partners
• Active interaction with other CMC team members to build the CMC development plan and ensuring execution thereof
• Conducting studies to increase the understanding of the molecule and support the process development activities in collaboration with the other CMC team members

Requirements

• Master degree or PhD in analytical chemistry or pharmaceutical sciences or any other related scientific field, or equivalent by experience
• At least 8 years industrial experience, working in hands-on analytical development roles in the pharmaceutical industry, and within multidisciplinary teams (Drug product formulation/ manufacturing, API synthesis, Quality, Regulatory)
• Extensive expertise in pharmaceutical quality control (API and drug product including oral solid dosage forms), physico-chemical tests (such as chromatographic and dissolution methods), microbiology. Experience in radiopharmaceuticals and/or injectables is a plus.
• Scientific curiosity is a must. Detail-oriented and capable of identifying and solving complex scientific problems.
• Good knowledge of regulatory and quality guidelines (GMP, Pharmacopeias, ICH, FDA guidances) applicable to investigational medicinal products. Experience in analytics of late phase assets and new drug application appreciated.
• Knowledge of innovative development and prediction tools, strong understanding in statistical analysis related to method validation are a plus.
• Good understanding of the management of a network of CDMO’s and CRO’s and working in cross functional teams.
• Good multi-tasking, time management, exemplary teamwork, organizational and self-management skills are essential
• Excellent knowledge of english
• Proficiency in all aspects of standard IT tools.

Benefits

• An international and highly dynamic environment.
• The opportunity to join a successful company, at the forefront of the most advanced scientific developments in the industry.
• The possibility to be in a company in which innovation, people and entrepreneurship are the fundamentals of its success.

For more information : www.debiopharm.com

Job Rewards and Benefits