Expert in Drug Product Formulation and Processing for Synthetic Molecule Parenterals (CMC Advisor) — Roche
NewCHF 49'500 - 75'000
Roche · Basel (BS)
- Location
- Basel
- Contract
- full-time
- Posted
- 2 days ago
SalaryCHF 49'500 - 75'000
Role overview
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.
- 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.
Application process
- Mentor and coach staff in preparation and authoring of CTA and New Drug Applications (NDAs).
- Collaborate with cross-functional stakeholders to address challenges and ensure success in research and development programs. 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.
Additional details
- Collaborate with cross-functional stakeholders to address challenges and ensure success in research and development programs.
Notes and original content
- Who You Are:
