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The Position
At Roche, we have an exciting opportunity for an expert in peptide parenteral formulation. You will be working on multiple innovative projects with cutting edge technologies that will have a meaningful impact on millions of lives.
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,as well as line extension development.
The Opportunity
As an expert in the development and launch of parenteral peptide formulations, your major responsibilities in this position are the following:
Drive the pharmaceutical development of cutting-edge peptide parenteral formulations, from clinical development all the way to market launch, including line extensions.
Development of robust manufacturing processes for both liquid and lyophilized peptide and small molecule formulations, overseeing scale-up, process characterization & validation, and seamless transfer to our global commercial manufacturing sites.
Act as Pharmaceutical Project Leader representing Pharmaceutical Development, in global CMC (Chemistry, Manufacturing, and Controls) teams, cross-functional initiatives, and international committees within Roche. You will play a pivotal role in shaping global regulatory submissions for all phases (Phase 1-3) and market approvals (MAA/NDA), making a direct impact on bringing life-changing medicines to patients.
Who you are
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 drug product manufacturing related fields of parenteral dosage forms for peptides parenterals.
Proven experience authoring drug product sections of an NDA for a peptide product and expert 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
If you are an expert in peptide formulations and enjoy driving innovation, we would love to hear from you.
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.
