Scientist II, Drug Product Development

Job Title: Scientist II, 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

• 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&PD 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 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
• 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 min 5 years of relevant experience, or a PhD holder with 0-1 years of relevant experience
• Knowledgeable and experienced in Biosimilar/Biologics/Protein/peptide formulation and DP process development (mandatory)
• Able to prove 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 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 (will be 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 a comprehensive written and verbal French communication skills will be an added advantage
• Dynamic, with good interpersonal skills such as team player

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.