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Senior Scientist, Drug Product Development (all genders)

Evotec
Full-time
On-site
Toulouse

Job Title: Senior Scientist, Drug Product Development Location: Toulouse Department: Process & Product Design Reports To: Senior Manager, Drug Product Development We’re excited to share this opportunity is part of the Sandoz acquisition of Just-Evotec Biologics in Toulouse. Through this opportunity you will impact the lives of hundreds of millions of people through bold ideas supported by an inclusive, agile company culture. Join us to help make healthcare fairer and faster, help us to pioneer access to medicine! Click to learn more. What You’ll Do: Lead the development of phase-appropriate formulations, drug product process development and perform stability studies. Implement pharmaceutical product development strategy and conduct formulation development and DP process experiments. Represent the Pharmaceutical Product Development function and work collaboratively with cross-functional P&PD teams to achieve organizational goals. Serve as project representative for pharmaceutical product development on cross-functional project teams. Work with external CMOs for outsourced activities, including pharmaceutical manufacturing. Optimize development strategies to increase efficiency and reduce risk of FIH, NIF and commercial formulations. Optimize development strategies for biosimilar formulations, taking into account intellectual property challenges. Act as a team member and collaborate with Just organization 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 Represent Just at external meetings related to important industry wide issues related to our business Provide technical expertise to internal and external teams regarding container closure for designing drug product Who You Are: Master’s degree in biotechnology, bioprocess engineering, pharmaceutical sciences, biochemistry or related filed with 10+years of relevant experience or Ph.D. with 7+years of relevant experience in pharmaceutical and or/biotechnology industry Experienced in Drug product development and/or manufacturing of sterile injectable dosage forms including frozen, liquid, formulations in vials, pre-filled syringes and autoinjectors Experienced in Biologics/Protein/peptide formulation and DP process development Practical hands-on experience of analytical techniques including HPLC/UPLC, Capillary Electrophoresis (CE), Isoelectric Focusing (IEF), Sub-visible particle analysis/characterization, DLS, DSC etc. Experience on design of experiment (DoE) tools such as JMP, MODDE etc. and statistical analysis for biologic and/or biosimilar products. Deep understanding of protein degradation and stabilization mechanisms Process Characterization & Validation – familiarity with QbD principles, DoE, risk assessments, and regulatory expectations for PPQ readiness. Technology Transfer & Scale-up – hands-on experience transferring processes across internal or external sites, including drafting tech transfer packages, BOM/BOE, and technical support for handling deviations/troubleshooting. CMC Knowledge – understanding of the drug development life cycle and contribution to IND/BLA-enabling activities 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 Excellent written and verbal communication skills in English, including the ability to communicate effectively over teleconference and web-based meetings Having a comprehensive written and verbal French communication skills will be an added advantage Dynamic, have good interpersonal skills and are a team player Influence across functional areas to drive innovation and alignment Why Sandoz? Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, touched the lives of almost 500 million patients last year and while we are proud of this achievement, we have an ambition to do more! With investments in new development capabilities, state-of-the-art production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably. Our momentum and entrepreneurial spirit is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged! The future is ours to shape! 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. Evotec is a life science company with a unique business model that delivers on its mission to discover and develop highly effective therapeutics and make them available to the patients. The Company’s multimodality platform comprises a unique combination of innovative technologies, data and science for the discovery, development, and production of first-in-class and best-in-class pharmaceutical products. Evotec leverages this “Data-driven R&D Autobahn to Cures” for proprietary projects and within a network of partners including all Top 20 Pharma and over 800 biotechnology companies, academic institutions, as well as other healthcare stakeholders. Evotec has strategic activities in a broad range of currently underserved therapeutic areas, including e.g. neurology, oncology, as well as metabolic and infectious diseases. Within these areas of expertise, Evotec aims to create the world-leading co-owned pipeline for innovative therapeutics and has to-date established a portfolio of more than 200 proprietary and co-owned R&D projects from early discovery to clinical development. Evotec operates globally with more than 5,000 highly qualified people. The Company’s 17 sites offer highly synergistic technologies and services and operate as complementary clusters of excellence. For additional information please go to www.evotec.com and follow us on X/Twitter @Evotec and LinkedIn. Please click on the link below to access and review our Privacy Information for Applicants: Privacy Information for Applicants

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