Responsibilities

• Overseeing drug substance and drug product analytical activities from the preclinical phase through clinical development and beyond.
• Review analytical methods, validation reports, release analytics, and stability studies,s and offer guidance to vendors - including troubleshooting.
• Apply and define phase-appropriate analytical strategies according to ICH guidelines for both drug substances and drug products and review/author 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 the drug supply chain in preclinical and clinical trials.
• Identify, select,t and manage appropriate Contract Development & Manufacturing Organizations (CDMOs) for appropriate development and manufacturing work of drugsubstancese and drugproductst under c GMP .
• Contribute tomaintainingn andgrowingd the CMC network of vendors byvendors oversight,site visits,t andauditst asan SME on ADQC.

Qualifications

• Ph D 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-solvingg,and 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 c GMP 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.

Interested Candidates may forward CV and Cover Letter to Careers-Basel@Monterosa Tx.com

Or apply online www.monterosatx.com
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 Qu EEN™ (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 Qu EEN 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 drug.