Scientist, Drug Product Design
Scientist, Drug Product Design
Evotec
Toulouse, France
The position requires strong management and leadership skills, 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, as well as experience leading scientific personnel 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 lead 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 with 10+years of relevant experience or Ph.D. with a minimum of 0-5 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
- Good written and verbal French communication skills
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