Expert in Drug Product Formulation and Processing for Synthetic Molecule Parenterals (CMC Advisor)

Roche seeks a Senior CMC Advisor in Basel to lead formulation and process development for synthetic peptide parenterals from Phase 1 through launch.

This position supports the company’s drug development portfolio by providing strategic scientific expertise in CMC. The role focuses on driving innovation within cross-functional teams while overseeing formulation and manufacturing process development for all clinical stages and market supply.

Responsibilities

• Create the technical roadmap for industrialization readiness of the peptides portfolio by collaborating with global stakeholders.
• Guide CMC teams in developing robust formulations and manufacturing processes for parenteral synthetic molecules, managing risks to ensure timely delivery.
• Monitor advancements in peptide research and formulation science to recommend cutting-edge practices.
• Lead scientific strategies and decision-making to optimize development and research plans.
• Mentor staff in preparing and authoring CTA and New Drug Applications (NDAs).
• Work with cross-functional partners to solve challenges and ensure success in R&D programs.

Requirements

• Ph.D. or master’s degree in chemistry, chemical/process engineering, or a related field.
• At least 6 years of industry experience in formulation and process development for peptide parenteral dosage forms.
• Proven experience authoring Drug Product sections of an NDA for peptide products.
• Background in developing and launching peptide combination products for parenteral use.
• Deep expertise in chemistry, solid-state characterization, and related scientific areas.
• Experience with peptide analytical techniques, aseptic manufacturing, scale-up, technology transfers, and regulatory/quality requirements.
• Direct experience writing and reviewing regulatory CMC source and submission documents.
• Ability to assess program and submission risks from a drug product formulation and manufacturing perspective.
• Strong communication and collaboration skills with effective stakeholder management.
• Problem-solving mindset with a passion for pharmaceutical innovation.
• Willingness to relocate to Basel.
• Availability to work from the office at least three days per week.

About the company

Roche employs over 100,000 people globally dedicated to advancing science. The company’s mission is to prevent, stop, and cure diseases while ensuring healthcare access for current and future generations. The culture fosters personal expression, open dialogue, and genuine connections, empowering employees to explore new possibilities and deliver life-changing healthcare solutions.

• Encourages personal expression, open dialogue, and genuine connections.
• Values, accepts, and respects employees for who they are.
• Empowers staff to explore new possibilities and foster creativity.
• Dedicated to advancing science to prevent, stop, and cure diseases.
• Committed to ensuring healthcare access for everyone today and for generations to come.