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Scientist, Formulation Development Lead
Il y a 2 mois
Job Summary
Just Evotec Biologics EU is seeking a highly skilled Scientist to lead the drug product formulation and manufacturing team at our facility in Toulouse, France. The ideal candidate will have strong management and leadership skills, knowledge of sterile drug product manufacturing, and a deep understanding of formulation development of therapeutic proteins from First-in-Human (FIH) through commercialization.
Key Responsibilities
- Design and execute formulation development studies to optimize development strategies that increase efficiency and de-risk FIH and commercial formulations.
- Collaborate with cross-functional teams, including Analytical, QC, QA, and Manufacturing, to ensure product quality and product stability.
- Serve as the formulation development lead on project teams and provide technical expertise to internal and external teams regarding glass and plastic vials, stoppers, and pre-filled syringes for designing drug product.
- Support successful DP manufacturing through external Contract Manufacturing Organizations (CMOs).
- Provide technical guidance on formulation development of novel compounds.
Requirements
- Master's degree in engineering, pharmaceutical sciences, biochemistry, or a related field with 10+ years of relevant experience, or Ph.D. with a minimum of 6 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.
About Just Evotec Biologics EU
Just Evotec Biologics EU is an integrated design company focused on the technology of biotherapeutics from molecule through manufacturing plant. We believe that technological innovation will accelerate development and dramatically reduce the cost of these vital medicines. Our mission is to design and apply innovative technologies to dramatically expand global access to biotherapeutics.
