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Lead Drug Product Formulation Scientist
Il y a 2 mois
Just Evotec Biologics EU is seeking a highly motivated and experienced Lead Drug Product Formulation Scientist to join our dynamic team in Toulouse, France.
In this role, you will play a pivotal part in the development and manufacturing of innovative biotherapeutic drug products. You will lead a team of scientists, collaborating closely with cross-functional partners across the organization to ensure product quality, stability, and successful commercialization.
Responsibilities:- Design and execute formulation development studies, optimizing strategies for increased efficiency and risk mitigation throughout the FIH and commercial phases.
- Collaborate effectively with Analytical, Quality Control (QC), Quality Assurance (QA), and Manufacturing teams to ensure product excellence and stability.
- Serve as the primary formulation development lead on cross-functional project teams, driving scientific progress and decision-making.
- Provide technical expertise and guidance to internal and external stakeholders regarding drug product design considerations for vials, stoppers, pre-filled syringes, and other relevant packaging materials.
- Contribute your expertise as a technical resource for the formulation development of novel compounds.
- Master's degree in Engineering, Pharmaceutical Sciences, Biochemistry, or a related field with 10+ years of relevant experience, or a Ph.D. with a minimum of 6 years of experience.
- Exceptional English written and verbal communication skills, including the ability to effectively communicate through teleconference and web-based meetings.
- In-depth understanding of protein stabilization mechanisms and analytical techniques such as UHPLC, CE, biophysics, particle measurements, and characterization.
- Experience in the manufacturing of sterile dosage forms (frozen, liquid, lyophilized) in vials and pre-filled syringes.
- Proven track record in DP process development.
- Knowledge of regulatory guidance from the FDA and EMA for the development of biologic drug products and biosimilars.
- Familiarity with USP and Ph. Eur. as it relates to biologics development.
- Proficiency in French (written and verbal) is a plus.
