CMC Expert Drug Product Synthetic Molecule Parenterals (Peptide Launch) job opportunity at Roche.

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DatePosted 5 Days Ago bot
Roche CMC Expert Drug Product Synthetic Molecule Parenterals (Peptide Launch)
Experience: 6-years
Pattern: full-time
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loacation Basel, Switzerland
loacation Basel....Switzerland

At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters. The Position The Pharmaceutical Development DP SM Parenterals group is responsible for the development of parenteral drug products Synthetic molecules from Phase 1 through Launch. Activities encompass formulation and manufacturing process development for all clinical stages and the market , the transfer of product and process to commercial manufacturing sites,as well as line extension development. We are seeking a seasoned expert to play an anchor role in the development and launch of parenteral peptide formulations, particularly within the Pharmaceutical Development DP SM Parenterals group in Pharma Technical Development (PTD) in Basel.  The opportunity: The position requires deep scientific expertise and strategic vision to support the drug development portfolio (CMC expertise) and drive innovation within cross-functional teams.  Develop the technical roadmap defining activities for industrialization readiness for the peptides portfolio through strategic collaboration with global stakeholders     Advise and coach the CMC teams for the development of robust formulations and manufacturing processes managing risks and mitigations for parenteral DP synthetic molecules portfolio ensuring timely delivery of technical activities  Stay updated on advancements in peptide research, formulation science, and parenteral drug development to advise on cutting-edge practices. Lead scientific strategies and decision-making processes to deliver optimized development and research plans. Mentor staff in preparation and authoring of CTA and New Drug Applications (NDAs). Collaborate with cross-functional stakeholders to address challenges and ensure success in research and development programs. Who You Are: You hold a Ph.D. or master’s degree in chemistry, chemical/process engineering, or related fields, with a minimum of 6 years of industry experience in formulation and process development for peptide parenteral dosage forms. Proven track record of authoring Drug Product (DP) sections of an NDA for peptide products and developing and launching peptide combination products for parenteral use. Deep expertise in chemistry, solid-state characterization, and related scientific fields. Experience in peptide analytical techniques, aseptic manufacturing processes, scale-up, technology transfers, and understanding regulatory and quality requirements. Direct experience in writing and reviewing regulatory CMC source and submission documents, with a demonstrated ability to assess program and submission risks from a drug product formulation and manufacturing perspective. Excellent communication and collaboration skills, with strong stakeholder management and the ability to think end-to-end and globally. A proven team player with a problem-solving mindset and a passion for innovation in the pharmaceutical field. We are looking for candidates based in or willing to relocate to Basel , with the expectation of working from the office a minimum of three days per week .     Who we are A healthier future drives us to innovate. Together, more than 100’000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact. Let’s build a healthier future, together. Roche is an Equal Opportunity Employer.

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