Senior Scientist, Drug Product Development (all genders) in Toulouse. Lead the development of phase-appropriate formulations, drug product process development and perform stability studies. Implement pharmaceutical product development strategy and conduct formulation development and DP process experiments.
Requirements
- Master’s degree in biotechnology, bioprocess engineering, pharmaceutical sciences, biochemistry or related field
- 10+ years of relevant experience or Ph.D. with 7+ years of relevant experience in pharmaceutical and/or biotechnology industry
- Experienced in Drug product development and/or manufacturing of sterile injectable dosage forms including frozen, liquid, formulations in vials, pre-filled syringes and autoinjectors
- Experienced in Biologics/Protein/peptide formulation and DP process development
- Practical hands-on experience of analytical techniques including HPLC/UPLC, Capillary Electrophoresis (CE), Isoelectric Focusing (IEF), Sub-visible particle analysis/characterization, DLS, DSC etc.
- Experience on design of experiment (DoE) tools such as JMP, MODDE etc. and statistical analysis for biologic and/or biosimilar products
- Deep understanding of protein degradation and stabilization mechanisms
- Process Characterization & Validation – familiarity with QbD principles, DoE, risk assessments, and regulatory expectations for PPQ readiness
- Technology Transfer & Scale-up – hands-on experience transferring processes across internal or external sites, including drafting tech transfer packages, BOM/BOE, and technical support for handling deviations/troubleshooting
- CMC Knowledge – understanding of the drug development life cycle and contribution to IND/BLA-enabling activities
- Knowledge of regulatory guidance from the FDA and EMA for development of biologic drug products and biosimilars
- Knowledge of USP and Ph. Eur. as it relates to biologics development
- Excellent written and verbal communication skills in English
- Having a comprehensive written and verbal French communication skills will be an added advantage
- Dynamic, have good interpersonal skills and are a team player
- Influence across functional areas to drive innovation and alignment
