Senior Scientist Drug Product Development (all genders)

Senior Scientist Drug Product Development (all genders)

Just is looking for an experienced and innovative senior scientist to join its dynamic, multidisciplinary Drug product development team at its J.POD site in Toulouse, France. This team is responsible for early-stage formulation development through to manufacturing process development for pharmaceutical products at all clinical stages and for all markets.

The ideal candidate will possess strong leadership skills, in-depth knowledge of sterile pharmaceutical manufacturing, as well as a thorough understanding of formulation development for therapeutic proteins, from first-in-human (FIH) trials through to commercialization. Proven experience in these technical areas, experience with pharmaceutical contract manufacturing organizations (DP CMOs), biosimilars, and scientific leadership at various skill levels is essential.

Missions and responsibilities :

1. Lead the development of phase-appropriate formulations and perform stability studies.
2. Implement pharmaceutical product development strategy and conduct formulation development and PD process experiments.
3. Represent the Pharmaceutical Product Development function and work collaboratively with cross-functional P&PD teams to achieve organizational goals.
4. Serve as project representative for pharmaceutical product development on cross-functional project teams.
5. Work with external CMOs for outsourced activities, including pharmaceutical manufacturing.
6. Optimize development strategies to increase efficiency and reduce risk of FIH and commercial formulations.
7. Optimize development strategies for biosimilar formulations, taking into account intellectual property challenges.
8. 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.
9. 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.
10. Represent Just at external meetings related to important industry wide issues related to our business.
11. Provide technical expertise to internal and external teams regarding container closure for designing drug product.

Knowledge, skills and abilities :

1. Dynamic, have good interpersonal skills and are a team player.
2. Knowledge of regulatory guidance from the FDA and EMA for development of biologic drug products and biosimilars.
3. Knowledge of USP and Ph. Eur. as it relates to biologics development.
4. Knowledge of analytical techniques including HPLC/UPLC, Capillary Electrophoresis (CE), Isoelectric Focussing (IEF), Sub-visible particle analysis etc.
5. Knowledge and understanding of DoE (design of experiments) and other statistical analysis techniques.
6. Having comprehensive written and verbal English and French communication skills.

Experience and education :

• 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.
• Experience in Drug product development and/or manufacturing of sterile dosage forms including frozen, liquid, formulations in vials and pre-filled syringes.
• Experience in Biologic/Protein formulation and DP process development.
• Practical hands-on experience of analytical techniques including HPLC/UPLC, Capillary Electrophoresis (CE), Isoelectric Focussing (IEF), Sub-visible particle analysis/characterisation, DLS 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 stabilization mechanisms.
• Excellent written and verbal communication skills in English, including the ability to communicate effectively over teleconference and web-based meetings.