Monte Rosa Therapeutics. looking for a CMC Scientist with ADQC expertise to support the supply of drug substance and drug product for molecular glue degrader (MGD) programs. The successful candidate will be involved in Chemistry Manufacturing and Control activities from preclinical to clinical and commercial stage. This person will interface with a variety of  CRO and CDMO activities not limited to monitoring and guiding analytical methods development and phase appropriate validations, QC oversight, managing outsourcing activities of both drug substance (including synthesis design, trouble shooting, process development) and drug product, contributing to the quality section of regulatory submissions. Superior experience in analytical development field of small molecule API in fast paced environments and in (early) phase development are considered an asset. Quality control experience is considered a plus. The candidate should also have excellent skills for working in a collaborative and cross-functional, dynamic environment.

• Overseeing drug substance and drug product analytical activities from preclinical phase through clinical development and beyond.
• Review analytical methods, validation reports, release analytics, stability studies and offer guidance to vendors including troubleshooting.
• Apply and define phase appropriate analytical strategies according to ICH guidelines for both drug substance and drug product and reviewing/authoring corresponding quality sections for regulatory submissions.
• Support the development and implementation of manufacturing strategies for drug substance and drug product
• Responsible (as needed) for drug substance and drug product development and manufacturing activities from preclinical phase through clinical development and beyond.
• Management of timelines, resources and budgets.
• Act as CMC lead, representing the CMC team within project teams by participating in project meetings and giving regular updates.
• Partner with project teams to seamlessly advance our small molecule development candidates into clinical development.
• Identify opportunities for strategic sourcing to reduce timelines to the clinic.
• Overall accountability for drug supply chain in preclinical and clinical trials.
• Identify, select and manage appropriate Contract Development & Manufacturing Organizations (CDMOs) for appropriate development and manufacturing work of drug substance and drug product under cGMP .
• Contribute to maintain and grow as needed the CMC network of vendors by vendors oversight, sites visit and audit as SME on ADQC.

• PhD or MSc in Organic or Analytical Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences or related scientific discipline, 5 years of industry experience in the pharmaceutical or biotech industry in small molecule analytical method development, scale-up, manufacturing, pre-formulation/formulation.
• Work experience on the main analytical techniques for both drug substance and drug product. Good understanding of organic synthesis and process development of small molecule API. Knowledge of formulation development of solid oral dosage forms is a plus.
• Experience in analytical development for projects in clinical development (Phase 1 through Phase 3).
• Thorough knowledge of ICH guidelines and most relevant FDA and EMEA regulations.
• Excellent interpersonal, communication and teamwork skills.
• Flexibility, problem solving, ability to work in a dynamic environment.
• Experience in different pharmaceutical dosage forms (e.g. tablets, capsules, parenteral, etc.) is considered a plus.
• Experience with cGMP manufacturing of both drug substance and drug product and IND, CTA and NDA filings is considered a plus.
• Experience in supply chain management is considered a plus.