Scientific Lead, Drug Product Development
Scientific Lead, Drug Product Design (m/f/d) | Toulouse, France |
Just is looking for a Scientific Lead for Drug Product Design to join a fast-paced, collaborative, and multidisciplinary team to lead the drug product formulation and manufacturing team at our J.POD facility in 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 at all skill levels is required.
- Build and lead a team encompassing all aspects of formulation development for clients from FIH through commercialization
- Represent Drug Product Design on cross-functional teams to execute on organizational goals
- Design and execute formulation development studies
- 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
- 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
- Independently manage staff, capital resources, and planning
- Be a technical resource for formulation development of novel compounds
- Act as an internal technical resource for Quality, Manufacturing and Process Design, as well as a resource and subject matter expert for external clients and collaborators
- Represent Just at external meetings related to important industry wide issues related to our business
- BS/MS in engineering, pharmaceutical sciences, biochemistry or related filed with 15+years of relevant experience or Ph.D. with 7+years of relevant experience
- Proven track record in mentoring, managing staff and leadership in cross functional teams
- 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 and understanding of DoE (design of experiments) and other statistical analysis techniques
- Knowledge of typical analytical techniques including UPLC, CE, biophysics, particle measurements and particle characterization
- 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
- Experience writing regulatory filings including INDs and BLAs
- 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
Just 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. Just is developing a portfolio of molecules that best leverages our technological strengths. The Just mission: design and apply innovative technologies to dramatically expand global access to biotherapeutics. Come join our team of experts to help shape a better future.
FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.
ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.