Scientist, Drug Process Development
il y a 3 jours
Scientist, Drug Process Development (all genders)
PERMANENT Contract
Just is looking for a Scientist of 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 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 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
Just is an integrated design company focused on the technology of biotherapeutics from molecule throughmanufacturing plant. We believe that technological innovation will accelerate development and dramaticallyreduce the cost of these vital medicines. Just is developing a portfolio of molecules that best leverages ourtechnological strengths. The Just mission: design and apply innovative technologies to dramatically expand globalaccess 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.
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