Expert in Drug Product Formulation and Processing for …, Basel

Position Overview

The Pharmaceutical Development DP SM Parenterals group is responsible for the development of parenteral drug products from Phase 1 through launch. Activities include formulation and manufacturing process development for all clinical stages, transfer of product and process to commercial sites, and line extension development. We seek a seasoned expert to anchor the development and launch of parenteral peptide formulations.Responsibilities

Develop the technical roadmap defining activities for industrialization readiness for the peptides portfolio through strategic collaboration with global stakeholders. Advise and coach CMC teams for the development of robust formulations and manufacturing processes, managing risks and mitigations for the peptides portfolio and 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 and coach 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. Qualifications

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 NDAs 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 transfer, and 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, strong stakeholder management, and a global, end-to-end mindset. A proven team player with a problem-solving mindset and a passion for innovation in the pharmaceutical field. Location

Based in or willing to relocate to Basel, with expectation to work from the office a minimum of three days per week. Equal Opportunity Employment

Roche is an Equal Opportunity Employer.

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