Senior Scientist, Drug Product Development (all genders)

Job Title: Senior Scientist, Drug Product Development

Location: Toulouse
Department: Process & Product Design
Reports To: Senior Manager, Drug Product Development

We’re excited to share this opportunity is part of the Sandoz acquisition of Just-Evotec Biologics in Toulouse. Through this opportunity you will impact the lives of hundreds of millions of people through bold ideas supported by an inclusive, agile company culture. Join us to help make healthcare fairer and faster, help us to pioneer access to medicine! Click to learn more.

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