Scientist, Drug Product Development

Evotec

·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;
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.

Holder of a Master’s degree in biotechnology, bioprocess engineering, pharmaceutical sciences, biochemistry or related filed with 0 to 5 years of relevant experience;
Knowledgeable and experienced with 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 Focussing (IEF), Sub-visible particle analysis/characterization, DLS, DSC etc.;
Knowledgeable on design experiments (DoE) tools such as JMP, MODDE etc. and statistical analysis for biologic and/or biosimilar products;
Comfortable with deep understanding of 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;
Language: very comfortable in English, including the ability to communicate effectively over teleconference and web-based meetings. At ease in French would be an added advantage;
Dynamic, having good interpersonal skills and being a team player;
Having a comprehensive written and verbal French communication skills will be an added advantage.