Senior/ Principal Scientist Pharmaceutical Development (parenteral peptide formulations)
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As a Principal Scientist in Pharmaceutical Development, you are part of the Department “Pharmaceutical Development” in Pharma Technical Development (PTD) in Basel, Switzerland. The department Pharmaceutical Development is responsible for the development of parenteral drug products (Synthetic molecules and Biologics) from Phase 1 through Launch. Activities encompass formulation and manufacturing process development for parenteral drug products for all clinical stages and the market, the transfer of product and process to commercial manufacturing sites, commercial product support and line extension development.
With a strong background in the development and launch of parenteral peptide formulations, your major contributions in this position are the following:
Pharmaceutical development of peptides parenteral formulations for clinical development and market (including line extensions)
Development of robust manufacturing processes for parenteral liquid and lyophilized formulations for peptides, small molecules including scale-up, process characterization & validation and transfer to global commercial manufacturing sites.
Representation of Pharmaceutical Development as pharmaceutical project leader in global CMC teams, functional representative in cross-functional teams and international committees within Roche.
Providing input to global regulatory submissions for Phase 1-3 and the market (BLA/MAA/NDA)
As the successful candidate you hold a Ph.D. or master degree in chemistry, chemical/process engineering or related fields and bring a minimum of 6 years of professional experience (industry) in formulation and process development DP manufacturing related fields of parenteral dosage forms for peptides parenterals.
Shown experience authoring DP sections of an NDA for a peptide product and expertise in developing and launching peptides as a combination product for parenteral use.
Strong expertise in chemistry, solid state characterization and its related field.
Experience in peptide analytical techniques, aseptic manufacturing process, scale-up, tech transfers and related regulatory and quality requirements
Direct experience in writing/reviewing regulatory CMC source and submission documents and demonstrated ability to evaluate program risk and submission risk from a drug product formulation and manufacturing standpoint.
Excellent communication skills and collaborative behaviors, with end-to-end and global thinking, as well as excellent stakeholder management skills
At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more.
Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.
We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.
Roche is an Equal Opportunity Employer.
