Scientist - CMC Process Chemistry

10h10 hours ago

Monte Rosa Therapeutics

Basel, CH · Full-time · CHF 130,000 – CHF 170,000

About this role

In this role the successful candidate will contribute to CMC tasks from discovery and preclinical stages through clinical and potentially commercial development. Responsibilities center on managing outsourcing for drug substance development and manufacturing from early phase onwards.

Daily work includes route scouting, process research, scale-up, manufacturing and material supply activities delivered through external vendors with a high level of independence. Troubleshooting, process optimization and analytical development occur during manufacturing campaigns.

Strong interaction with medicinal chemistry supports early synthesis improvements while liaison with toxicology and clinical teams advances candidates into preclinical and clinical phases. Cross-functional project teams rely on the CMC lead for regular updates and guidance.

The position also covers physico-chemical and solid-state studies, CDMO selection, and preparation of CMC regulatory documents for IND and other submissions. Drug supply chain oversight for preclinical and clinical trials completes the scope.

Requirements

PhD or MSc in Organic Chemistry, Pharmaceutical Chemistry, Pharmaceutical sciences or related scientific discipline.
2-7 years of relevant experience in process chemistry, chemical or analytical development, scale-up or manufacturing with small molecule drugs.
Sound knowledge of organic chemistry and process development of small molecule API.
Understanding of technical development from preclinical stage through clinical phases.
Experience of GMP manufacturing of drug substances and/or drug products.
Experience of managing CDMOs and complex supply chains.

Responsibilities

Deliver drug substance through external vendors including route scouting, process research and development, scale-up, manufacturing and material supply from preclinical phase onwards.
Assess existing routes of synthesis, identify bottlenecks and design alternative synthesis solutions with troubleshooting during scale-up and manufacturing.
Contribute to strategies for drug substance manufacture covering process development, raw material procurement and phase-appropriate analytical control strategies.
Manage timelines, resources and budgets while acting as CMC lead and point of contact in cross-functional project teams.
Establish interaction with medicinal chemistry to support early development and liaise with toxicology and clinical teams to advance candidates.
Manage physico-chemical and solid-state studies including polymorphism, solubility and early formulation to assess developability.
Identify, select and manage CDMOs for process development work and GMP supply of drug substance and drug product.
Prepare, review and edit CMC regulatory documents and liaise with regulatory teams for IND and other submissions.