Scientist II, Drug Product Development (all genders)
TOULOUSE, 31
il y a 1 jour
Scientist II, Drug Product Development
Location: Toulouse
Department: Process & Product Design
Reports To: Senior Manager, Drug Product Development
What You’ll Do
- Design and execute phase‑appropriate formulation, drug product process development and stability studies.
- Implement pharmaceutical product development strategy and conduct formulation development and PD process experiments.
- Represent the Drug Product Development function and work collaboratively with cross‑functional P&D teams to achieve organizational goals.
- Work with external CMOs for outsourced activities, including pharmaceutical manufacturing.
- Execute development strategies to increase efficiency and reduce risk of FIH, NIF and commercial formulations.
- Optimize development strategies for biosimilar formulations, considering intellectual property challenges.
- Act as a team member and collaborate with partner groups, including analytical, quality control, quality assurance and manufacturing teams, to ensure product quality and stability.
- 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.
- Be a technical resource to internal and external teams regarding formulation, stability and container closure for designing drug product.
Who You Are
- Holder of a Master’s degree in biotechnology, bioprocess engineering, pharmaceutical sciences, biochemistry or related field with a minimum of 5 years of relevant experience, or a Ph.D. holder with 0-1 years of relevant experience.
- Knowledgeable and experienced in Biosimilar/Biologics/Protein/peptide formulation and DP process development (mandatory).
- Proven practical hands‑on experience of analytical techniques including HPLC/UPLC, Capillary Electrophoresis (CE), Isoelectric Focusing (IEF), sub‑visible particle analysis/characterization, DLS, DSC, etc.
- Knowledgeable and experienced with design of experiments (DoE) tools such as JMP, MODDE, etc., and statistical analysis for biologic and/or biosimilar products.
- Comfortable with deep understanding of protein‑protein interactions, protein degradation and stabilization mechanisms.
- Experienced in drug product development and/or manufacturing of sterile injectable dosage forms including frozen, liquid formulations in vials, pre‑filled syringes and autoinjectors (preferred).
- Knowledgeable of regulatory guidance from the FDA and EMA for development of biologic drug products and biosimilars.
- Knowledgeable of USP and Ph.Eur. as it relates to biologics development.
- Fluent in English (mandatory).
- Having comprehensive written and verbal French communication skills will be an added advantage.
- Dynamic, with good interpersonal skills such as being a team player.
Equal Opportunity Employer & Diversity Statement
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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Entreprise
Evotec WD
Plateforme de publication
WHATJOBS
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