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

Who You Are:

• You hold a Ph.D. or master’s degree in chemistry, chemical/process engineering, or related fields, with a minimum of 6 years of industry experience in formulation and process development for peptide parenteral dosage forms.

• Proven track record of authoring Drug Product (DP) sections of an NDA for peptide products and developing and launching peptide combination products for parenteral use.

• Deep expertise in chemistry, solid-state characterization, and related scientific fields.

• Experience in peptide analytical techniques, aseptic manufacturing processes, scale-up, technology transfers, and understanding regulatory and quality requirements.

• Direct experience in writing and reviewing regulatory CMC source and submission documents, with a demonstrated ability to assess program and submission risks from a drug product formulation and manufacturing perspective.

• Excellent communication and collaboration skills, with strong stakeholder management and the ability to think end-to-end and globally.

• A proven team player with a problem-solving mindset and a passion for innovation in the pharmaceutical field.

We are looking for candidates based in or willing to relocate to Basel, with the expectation of working from the office a minimum of three days per week.