Senior/ Principal Scientist – Peptide pharmaceutical development Full-time

The Position at Roche

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 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.

Roche is an Equal Opportunity Employer.