Scientist II, Drug Product Development

Evotec

Toulouse, France

What You’ll Do:

• Design and execute phase-appropriate formulation, drug product process development and stability studies.
• Implement pharmaceutical product development strategy and conduct formulation development and PD process experiments.
• Represent the Drug Product Development function and work collaboratively with cross-functional P&PD teams to achieve organizational goals.
• Work with external CMOs for outsourced activities, including pharmaceutical manufacturing.
• Execute development strategies to increase efficiency and reduce risk of FIH, NIF and commercial formulations.
• Optimize development strategies for biosimilar formulations, considering 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
• Be a technical resource to internal and external teams regarding formulation, stability and container closure for designing drug product.

Who You Are:

• Holder of a Master’s degree in biotechnology, bioprocess engineering, pharmaceutical sciences, biochemistry or related field with min 5 years of relevant experience, or a PhD holder with 0-1 years of relevant experience
• Knowledgeable and experienced in Biosimilar/Biologics/Protein/peptide formulation and DP process development (mandatory)
• Able to prove practical hands-on experience of analytical techniques including HPLC/UPLC, Capillary Electrophoresis (CE), Isoelectric Focusing (IEF), Sub-visible particle analysis/characterization, DLS, DSC etc.
• Knowledgeable and experienced with design experiments (DoE) tools such as JMP, MODDE etc. and statistical analysis for biologic and/or biosimilar products.
• Comfortable with deep understanding of protein-protein interactions, protein degradation and stabilization mechanisms.
• Experienced in Drug product development and/or manufacturing of sterile injectable dosage forms including frozen, liquid, formulations in vials, pre-filled syringes and autoinjectors (will be preferred).
• Knowledgeable of regulatory guidance from the FDA and EMA for development of biologic drug products and biosimilars.
• Knowledgeable of USP and Ph. Eur. as it relates to biologics development
• Fluent in English (mandatory). Having a comprehensive written and verbal French communication skills will be an added advantage
• Dynamic, with good interpersonal skills such as team player