Scientist I/II Analytical CMC & QC

Monte Rosa Therapeutics seeks a Scientist I/II for Analytical CMC & QC in Basel to oversee analytical strategies and drug supply for molecular glue degrader programs from preclinical through clinical stages.

This position is responsible for managing analytical activities related to the development and supply of drug substances and products for molecular glue degrader initiatives. The role covers Chemistry, Manufacturing, and Control (CMC) tasks spanning from preclinical research to clinical trials and potential commercialization, ensuring robust analytical strategies and quality standards are met.

Responsibilities

• Directs analytical workflows for drug substances and products across preclinical, clinical, and post-clinical phases.
• Reviews and approves analytical reports, method validations, stability protocols, and release documentation.
• Acts as the primary analytical contact for Contract Development and Manufacturing Organizations (CDMOs), providing oversight and troubleshooting support.
• Selects and manages CDMOs for cGMP-compliant manufacturing of drug substances and products.
• Defines phase-appropriate analytical strategies in alignment with ICH guidelines.
• Authors and reviews quality sections for regulatory submissions.
• Supports the creation and execution of manufacturing strategies for drug substances and products.
• Coordinates with project teams to advance small molecule candidates into clinical development.
• Identifies strategic sourcing opportunities to accelerate timelines to clinical trials.
• Maintains overall accountability for the drug supply chain during preclinical and clinical studies.
• Manages project timelines, resources, and budgets as required.

Requirements

• PhD or MSc in Organic Chemistry, Analytical Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences, or a related field.
• For PhD holders: minimum two years of experience in pharmaceutical or biotech analytical roles; for MSc holders: minimum five years.
• Hands-on experience with key analytical techniques for drug substances or products.
• Solid understanding of organic synthesis and process development for small molecule Active Pharmaceutical Ingredients (APIs).
• Proven experience in analytical development for clinical projects (Phase I through Phase III).
• Comprehensive knowledge of ICH guidelines and relevant FDA and EMA regulations.
• Strong interpersonal, communication, and teamwork abilities.
• Flexibility and problem-solving skills suited for a dynamic work environment.

Nice to have

• Advanced experience in analytical development and Quality Control for small molecule APIs in early-phase development.
• Knowledge of formulation development, particularly solid oral dosage forms.
• Experience with various pharmaceutical dosage forms, such as tablets, capsules, or parenterals.
• Background in cGMP manufacturing of drug substances and products, including involvement in IND, IMPD, NDA, and MAA filings.

About the company

Monte Rosa Therapeutics operates in a collaborative and cross-functional environment, emphasizing dynamic teamwork to advance its scientific goals.

• Emphasis on collaborative and cross-functional teamwork.
• Dynamic work environment requiring adaptability.