Senior Scientist CMC, API - Process Chemistry

Monte Rosa Therapeutics, Inc

  • Basel
  • Unbefristet
  • Vollzeit
  • 15 Tage her
Overview: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 discovery/preclinical stage to clinical and potentially commercial stage. This includes managing outsourcing activities for 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 team working and cross-functional collaboration are critical in this role. Responsibilities:
  • Delivery of external drug substance and drug product including scale-up, manufacturing and material supply activities from preclinical phase onwards with high level of independence.
  • Synthesis & formulation assessment and design, trouble shooting, process and analytical development.
  • Contribute to the development and implementation of strategies to manufacture drug substance including process development, procurement of raw materials, 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 provide 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, 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 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 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 preclinical stage till clinical phases.
  • Experience of GMP manufacturing drug substances and/or drug products.
  • Experience of 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.

Monte Rosa Therapeutics, Inc