Scientist, Drug Process Development

Evotec

Toulouse, France

Just is looking for a Scientist of Drug Product Design to join a fast-paced, collaborative, and multidisciplinary team to join the drug product formulation and manufacturing team at our J.POD facility in Toulouse, France. The position requires knowledge of sterile drug product manufacturing, and a deep understanding of formulation development of therapeutic proteins from FIH through commercialization. A proven track record of technical skills in these areas, experience working with DP CMO’s is required.

Responsibilities:

Design and execute formulation development studies
Optimize development strategies that increase efficiency and de-risk FIH and commercial formulations
Collaborate with partner groups across the Just organization including Analytical, QC, and QA and Manufacturing to ensure product quality and product stability
Serve as the formulation development reference on cross-functional project teams
Support successful DP manufacturing through external CMO’s
Provide technical expertise to internal and external teams regarding glass and plastic vials, stoppers, and pre-filled syringes for designing drug product
Be a technical resource for formulation development of novel compounds

Requirements:

MS in engineering, pharmaceutical sciences, biochemistry or related filed up to 5+years of relevant experience or Ph.D. up to 2 years of relevant experience
Excellent English written and verbal communication skills, including the ability to communicate effectively over teleconference and web-based meetings
Deep understanding of protein stabilization mechanisms
Knowledge of typical analytical techniques including UHPLC, CE, biophysics, particle measurements and particle characterization

Preferred Qualifications:

Experience in DP manufacturing of sterile dosage forms including frozen, liquid, and lyophilized formulations in vials and pre-filled syringes
Experience in DP process development
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

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