Scientist - CMC Process Chemistry

1d1 day ago

Monte Rosa Therapeutics

Basel, CH · Full-time · CHF 120,000 – CHF 170,000

About this role

In this exciting role, the successful candidate will contribute to CMC tasks from discovery/preclinical stage to clinical and potentially commercial stage. This includes managing outsourcing activities for development and manufacturing of drug substance from early phase onwards, including route scouting, process development and compounds supply from pre-IND to clinics. Strong experience in process chemistry of small molecule APIs is critical.

The role involves delivery through external vendors of drug substance including route scouting, process research and development, scale-up, manufacturing and material supply activities from preclinical phase onwards with high level of independence. Assessment of existing routes of synthesis, bottlenecks identification and design of alternatives occur during manufacturing and scale-up, along with troubleshooting and analytical development. Contribute to strategies for manufacturing drug substance including process development and phase appropriate analytical activities.

Act as CMC lead and point of contact in cross-functional project teams, participating in project meetings and providing regular updates. Establish strong interaction with medicinal chemistry to support early development efforts. Liaise with toxicology and clinical teams to advance small molecule development candidates into preclinical and clinical development.

Manage physico-chemical and solid state studies of small molecule drug substances including polymorphism and solubility to assess developability. Identify, select and manage CDMOs for process development and GMP supply of drug substance. Prepare and review CMC regulatory documents for INDs and other submissions in a fast-paced dynamic environment.

Requirements

PhD or MSc in Organic Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences or related scientific discipline
2-7 years of relevant experience in the pharmaceutical or biotech industry in process chemistry, chemical or analytical development, scale-up, manufacturing or pre-formulation with small molecule drugs
Sound knowledge of organic chemistry and process development of small molecule API
Understanding of technical development from preclinical stage till clinical phases
Experience of GMP manufacturing 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 alternatives and synthesis solutions during manufacturing and scale-up with troubleshooting
Contribute to development and implementation of strategies to manufacture drug substance including process development, raw materials procurement and control strategies
Manage timelines, resources and budgets for assigned projects
Act as CMC lead and point of contact in cross-functional project teams, participating in meetings and providing updates
Establish strong interaction with medicinal chemistry to support early development efforts and synthesis improvements
Manage physico-chemical and solid state studies including polymorphism, solubility and early formulation for developability assessment
Identify, select and manage CDMOs for process development and GMP supply of drug substance and drug product