Senior/ Principal Scientist - Peptide parenteral formulation development

F. Hoffmann-La Roche Gruppe; Basel; Vor Ort; CHF 100’000 - 140’000; Vollzeit

Zusammenfassung

A leading pharmaceutical company is seeking a Principal Scientist in Pharmaceutical Development to spearhead innovative projects in peptide parenteral formulations. This role involves overseeing drug product development from Phase 1 to market launch, requiring extensive expertise and 6+ years of industry experience in formulation and process development.

Qualifikationen

• At least 6 years of industry experience in drug formulation and process development.
• Proven experience authoring NDA drug product sections.
• Strong expertise in chemistry and solid-state characterization.

Aufgaben

• Drive pharmaceutical development of peptide formulations from clinical to market.
• Develop robust manufacturing processes and oversee scale-up and validation.
• Act as Pharmaceutical Project Leader for global CMC teams and regulatory submissions.

Kenntnisse

Expertise in peptide formulations

Excellent communication skills

Stakeholder management

Ausbildung

Ph.D. or Master’s degree in chemistry or related fields

Jobbeschreibung

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

At Roche, we have an exciting opportunity for an expert in peptide parenteral formulation. You will work 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 will be part of the Department “Pharmaceutical Development” in Pharma Technical Development (PTD) in Basel, Switzerland. The department is responsible for developing parenteral drug products (Synthetic molecules and Biologics) from Phase 1 through Launch, including formulation and manufacturing process development, transfer to commercial manufacturing sites, and line extension development.

The Opportunity

Your major responsibilities include:

• Driving the pharmaceutical development of cutting-edge peptide parenteral formulations, from clinical development to market launch, including line extensions.
• Developing robust manufacturing processes for liquid and lyophilized peptide and small molecule formulations, overseeing scale-up, process characterization & validation, and transfer to global manufacturing sites.
• Acting as Pharmaceutical Project Leader in global CMC teams, cross-functional initiatives, and international committees, shaping regulatory submissions for all phases and market approvals, impacting patient access to medicines.

Who you are

You hold a Ph.D. or Master’s degree in chemistry, chemical/process engineering, or related fields, with at least 6 years of industry experience in formulation and process development of parenteral drug products for peptides.

• Proven experience authoring drug product sections of NDAs for peptide products and expertise in developing and launching peptides as parenteral combination products.
• Strong expertise in chemistry, solid-state characterization, and related fields.
• Experience with peptide analytical techniques, aseptic manufacturing, scale-up, tech transfers, and regulatory requirements.
• Experience in writing/reviewing regulatory CMC documents and evaluating program and submission risks from formulation and manufacturing perspectives.
• Excellent communication, stakeholder management, and collaborative skills, with a global mindset.

If you are an expert in peptide formulations and enjoy driving innovation, we would love to hear from you.

Who we are

Driven by a healthier future, over 100,000 Roche employees worldwide are dedicated to advancing science and ensuring access to healthcare. We have treated over 26 million people and conducted more than 30 billion diagnostics tests. We foster creativity, explore new possibilities, and aim to deliver life-changing healthcare solutions globally.

Let’s build a healthier future, together.

Roche is an Equal Opportunity Employer.