Senior scientist CMC, API process chemistry

Senior Scientist CMC, API process chemistry
Location: Basel, Switzerland

Monte Rosa Therapeutics (MRT) seeks to recruit an enthusiastic, creative, and highly talented scientist to join our growing CMC group in Basel, supporting the discovery of molecular glue degraders (MGDs) that eliminate disease-causing proteins previously thought undruggable. In this exciting role, the successful candidate will contribute to all CMC tasks from the discovery/preclinical stage to the clinical and potentially commercial stage. This includes managing outsourcing activities for the development and manufacturing of both drug substance and drug product, and early phase formulation. Strong experience in process development of small molecule APIs, the desire to work in a fast-paced, dynamic environment, and excellent teamwork and cross-functional collaboration are critical in this role.

Principal Duties and Key Responsibilities
• Delivery of external drug substance and drug product, including scale-up, manufacturing, and material supply activities from preclinical phase onwards with a high level of independence.
• Synthesis & formulation assessment and design, troubleshooting, process and analytical development.
• Contribute to the development and implementation of strategies to manufacture drug substance, including process development, procurement of raw materials, and phase-appropriate analytical activities.
• Management of timelines, resources, and budgets.
• On assigned projects, act as CMC lead and point of contact in cross-functional project teams by participating in project meetings and providing regular updates.
• Liaise with medicinal chemistry, toxicology and clinical teams to seamlessly advance our small molecule development candidates into preclinical & clinical development.
• Manage physico-chemical and solid state studies of small molecule drug substances, including polymorphism, solubility, early formulation studies, etc., to assess developability and formulation strategies for clinical development and commercialization.
• Identify, select and manage appropriate Contract Development & Manufacturing Organizations (CDMOs) for appropriate process development work and for the GMP supply of drug substance and drug product.
• Prepare, review, and edit CMC regulatory and quality documents (batch records, analytical validations, reports, and protocols).
• Liaise with the regulatory team for drafting and reviewing documents for INDs and other regulatory submissions.
• Responsible for the drug supply chain in preclinical and clinical trials.

Qualifications

• PhD or MSc in Organic Chemistry, Pharmaceutical Chemistry, Pharmaceutical sciences or related scientific discipline
• 4-7 years of relevant post-doc experience in the pharmaceutical or biotech industry in areas such as: process development, chemical or analytical development & scale-up, manufacturing (pilot or large scale), pre-formulation/formulation or CMC with small molecule drugs.
• Sound knowledge of organic chemistry and process development of small molecule API.
• Understanding of technical development needs from the preclinical stage to the clinical phases.
• Experience in GMP manufacturing of drug substances and/or drug products.
• Experience in managing CDMOs and complex supply chains.
• Other desirable experience: large molecule development and formulation; experience with different pharmaceutical dosage forms (e.g., tablets, capsules, parenteral, etc.), support of clinical development (Phase 1 through Phase 3), including IND, CTA, and NDA filings; FDA and EMEA regulations are considered a plus.
• Needs to be highly effective in cross-functional and cross-site teams
• Flexibility, problem-solving skills, and ability to adapt to a highly dynamic environment.

Interested Candidates may forward a CV and Cover Letter in a single PDF via our online portal https://www.monterosatx.com/careers/

Monte Rosa Therapeutics (MRT) is a clinical-stage biotechnology company developing highly selective molecular glue degrader (MGD) medicines for patients living with serious diseases in the areas of oncology, autoimmune and inflammatory diseases, and more. MGDs are small-molecule protein degraders that have the potential to treat many diseases that other modalities, including other degraders, cannot. Monte Rosa’s QuEEN™ (Quantitative and Engineered Elimination of Neosubstrates) discovery engine combines AI-guided chemistry, diverse chemical libraries, structural biology, and proteomics to identify degradable protein targets and rationally design MGDs with unprecedented selectivity. The QuEEN discovery engine enables access to a wide-ranging and differentiated target space of well-validated biology across multiple therapeutic areas. Monte Rosa has developed the industry’s leading pipeline of MGDs, which spans oncology, autoimmune and inflammatory disease, and beyond, and has a strategic collaboration with Roche to discover and develop MGDs against targets in cancer and neurological diseases previously considered impossible to treat.
To learn more about MRTx, visit www.monterosatx.com