Scientist, Drug Process Development

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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