Scientist , CMC Process Chemistry

Monte Rosa Therapeutics seeks a Scientist for CMC Process Chemistry in Basel to lead small molecule drug substance development from preclinical through commercial stages.

This position serves as the CMC lead for small molecule programs, guiding process chemistry tasks from early discovery and preclinical phases into clinical trials and potential commercialization. The scientist manages external manufacturing partnerships, oversees supply chain logistics, and ensures seamless advancement of development candidates through cross-functional collaboration.

Responsibilities

• Oversee external vendors for drug substance delivery, including route scouting, process R&D, scale-up, and manufacturing starting from the preclinical phase.
• Evaluate current synthesis routes, identify bottlenecks, and design alternative solutions to improve efficiency.
• Resolve technical issues during manufacturing and scale-up, supporting both process and analytical development.
• Develop and implement strategies for drug substance manufacturing, including raw material procurement, phase-appropriate analytical activities, and control strategies.
• Manage project timelines, resources, and budgets with a high degree of autonomy.
• Act as the primary CMC point of contact in cross-functional teams, providing regular updates during project meetings.
• Collaborate closely with medicinal chemistry teams to support early development efforts and implement synthesis improvements.
• Coordinate with toxicology and clinical teams to advance small molecule candidates into preclinical and clinical development.
• Manage physico-chemical and solid-state studies, such as polymorphism and solubility, to assess developability and inform formulation strategies.
• Select, evaluate, and manage Contract Development & Manufacturing Organizations (CDMOs) for process development and GMP supply of drug substance and product.
• Prepare, review, and edit CMC regulatory and quality documents, including batch records, analytical validations, reports, and protocols.
• Work with the regulatory team to draft and review documents for INDs and other regulatory submissions.
• Ensure reliable drug supply chain management for preclinical and clinical trials.

Requirements

• PhD or MSc in Organic Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences, or a related scientific field.
• 2–7 years of experience in the pharmaceutical or biotech industry, focusing on process chemistry, chemical/analytical development, scale-up, manufacturing, or pre-formulation with small molecule drugs.
• Strong knowledge of organic chemistry and process development for small molecule APIs.
• Understanding of technical development from preclinical stages through clinical phases.
• Experience with GMP manufacturing of drug substances and/or drug products.
• Proven ability to manage CDMOs and complex supply chains.
• Highly effective in cross-functional and cross-site team environments.

Nice to have

• Experience with large molecule development and formulation.
• Familiarity with various pharmaceutical dosage forms, such as tablets, capsules, or parenterals.
• Support for clinical development phases (Phase 1–3), including IND, CTA, and NDA filings.
• Knowledge of FDA and EMEA regulations.
• Experience in process validation and registration.

About the company

Monte Rosa Therapeutics operates in a fast-paced, dynamic environment, providing scientists with the opportunity to contribute to innovative drug development from early stages through to commercialization.

• Fast-paced and dynamic work environment.