Scientist, Drug Product Development (all genders)
Department: Process & Product Design
Reports To: Senior Manager, Drug Product Development About Us: this is who we are At Just Evotec Biologics , we believe that curiosity is the spark that drives innovation and success. As a forward-thinking team, we thrive on challenging the status quo, learning from each other, and pushing the boundaries of what's possible. We're on a mission to create a place where curiosity isn't just encouraged-it's celebrated. Are you someone who asks questions, seeks answers, and isn't afraid to go deeper? #BeCUREious with us and see where your curiosity can take you! The Role: Your challenge ...in our journey We're looking for a passionate and curious Scientistto join our team. If you're excited by new challenges, solving complex problems, and learning every step of the way, you might just be the perfect fit. In this role, you'll have the opportunity to drive impactful projects, collaborate with bright minds, and explore uncharted territories. As a Scientist, Drug Product Development at Just Evotec Biologics, you'll have the freedom to ask the hard questions, think outside the box, and find creative solutions that push us forward. It's a role where your curiosity will fuel both your personal growth and the success of the team. 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
- Holder of a Master's degree in biotechnology, bioprocess engineering, pharmaceutical sciences, biochemistry or related filed with 0 to 5 years of relevant experience
- Knowledgeable and experienced with 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 Focussing (IEF), Sub-visible particle analysis/characterization, DLS, DSC etc.
- Knowledgeable on design experiments (DoE) tools such as JMP, MODDE etc. and statistical analysis for biologic and/or biosimilar products.
- Comfortable with deep understanding of 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
- Language : very comfortable in English, including the ability to communicate effectively over teleconference and web-based meetings. At ease in French would be an added advantage
- Dynamic, having good interpersonal skills and being a team player
- Having a comprehensive written and verbal French communication skills will be an added advantage
- Growth Opportunities : We're a company that believes in continuous learning and development. Whether it's professional courses, mentorship, or new projects, we'll help you grow.
- Flexible Work Environment : We offer flexible work options to help you balance your professional and personal life.
- Inclusive Culture : We're committed to building a diverse and inclusive environment where everyone's voice is valued, and curiosity is encouraged.
- Innovative Projects : You'll have the chance to work on groundbreaking initiatives and cutting-edge technology in an atmosphere where your curiosity is the key to success.
- A Place for Big Ideas : We don't just talk about thinking outside the box-we throw the box away. If you've got ideas, we want to hear them.
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