Senior Scientist, Drug Product Development

Senior Scientist, Drug Product Development

Evotec

Toulouse, France

What You’ll Do:

• 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.
• Represent the Pharmaceutical Product Development function and work collaboratively with cross-functional P&PD teams to achieve organizational goals.
• Serve as project representative for pharmaceutical product development on cross-functional project teams.
• Work with external CMOs for outsourced activities, including pharmaceutical manufacturing.
• Optimize development strategies to increase efficiency and reduce risk of FIH, NIF and commercial formulations.
• Optimize development strategies for biosimilar formulations, taking into account intellectual property challenges.
• Act as a team member and collaborate with Just organization partner groups, including analytical, quality control, quality assurance and manufacturing teams, to ensure product quality and stability.
• Act as an internal technical resource for Quality, Manufacturing and Process Design, as well as a resource and subject matter expert for external clients and collaborators
• Represent Just at external meetings related to important industry wide issues related to our business
• Provide technical expertise to internal and external teams regarding container closure for designing drug product

Who You Are:

• Master’s degree in biotechnology, bioprocess engineering, pharmaceutical sciences, biochemistry or related filed with 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, including the ability to communicate effectively over teleconference and web-based meetings
• 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