Teams at Monte Rosa Therapeutics

Provides strategic GCP and GCLP quality oversight for preclinical and clinical programs. Responsibilities include vendor and investigator site oversight, SOP authorship, risk-based compliance programs, CAPA and quality event management, training, audits, regulatory submission review, inspection readiness, and cross-functional collaboration. Requires extensive pharmaceutical or biopharmaceutical experience, knowledge of global GCP regulations, and leadership in matrixed startup environments.

Coordinates regulatory workflows and prepares FDA and international regulatory submissions, license renewals, and annual registrations. Reviews and formats clinical, CMC, and non-clinical documentation; tracks timelines and budgets; researches regulatory requirements; supports product registration; and interacts with regulatory agencies. Requires extensive small-molecule CMC expertise, FDA filing experience, and strong project management, analytical, organizational, and communication skills.

Manage compound storage, retrieval, distribution, solution preparation, and automated plate production for screening teams. Track compound transfers using software, maintain laboratory equipment and safety standards, and support small-molecule degrader discovery. Requires hands-on sample management experience, LIMS and laboratory automation knowledge, strong documentation accuracy, organizational skills, and effective collaboration in a chemistry laboratory environment.