Job Description

To support our growing pipeline, we are looking to fill an exciting position at Monte Rosa Therapeutics. The CMC team is looking for a Scientist, Analytical CMC& QC with Analytical expertise to support analytical activities related to the development and 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 potentially commercial stage. This includes but is not limited to managing, monitoring and guiding analytical activities, such as methods development, phase appropriate validations, stability studies, release of non-GMP and GMP material, defining appropriate control strategies and QC oversight for both drug substance and drug product. In addition, contributions to the quality section of regulatory submissions are expected. Superior experience in analytical development fields and in Quality Control of small molecule API in (early) phase development is considered an asset. The candidate should also have excellent skills for working in a collaborative and cross-functional, dynamic environment.

Responsibilities

• Oversees drug substance and drug product analytical activities from preclinical phase through clinical development and beyond.
• Guides and reviews analytical reports, analytical methods, validation and stability protocols and reports and release documentation.
• Participates to the Contract Development & Manufacturing Organizations (CDMO’s) oversight as analytical responsible person
• Offers guidance to the CDMO including troubleshooting.
• Identifies, selects and manages appropriate CDMO’s for appropriate development and manufacturing work of drug substance and drug product under cGMP.
• Applies and defines phase appropriate analytical strategies according to ICH guidelines for both drug substance and drug product.
• Reviews/authors corresponding quality sections for regulatory submissions.
• Supports the development and implementation of manufacturing strategies for drug substance and drug product.
• Is responsible (as needed) for drug substance and drug product development and manufacturing activities from preclinical phase through clinical development and beyond.
• Manages timelines, resources and budgets as needed.
• Partners with project teams to seamlessly advance our small molecule development candidates into clinical development.
• Identifies opportunities for strategic sourcing to reduce timelines to the clinic.
• Overall accountability for drug supply chain in preclinical and clinical trials.

Qualifications

• PhD or MSc in Organic or Analytical Chemistry, Pharmaceutical Chemistry, Pharmaceutical Sciences or related scientific discipline.
• Two (for PhD) or five (for MSc) years of experience in the pharmaceutical or biotech industry in analytical areas such as method development and validation, release and stability studies for drug substance and/or drug product of small molecules.
• Work experience on the main analytical techniques for drug substance /or drug product. Good understanding of organic synthesis and process development of small molecule API. Knowledge of formulation development (mainly solid oral dosage forms) is considered a plus.
• Experience in analytical development for projects in clinical development (Phase I through Phase III).
• Thorough knowledge of ICH guidelines and most relevant FDA and EMA 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, IMPD, NDA and MAA filings is considered a plus.