Senior Scientist CMC, API

vor 2 Wochen

Basel, Basel-Stadt, Schweiz Monte Rosa Therapeutics, Inc Vollzeit CHF 120'000 - CHF 180'000 pro Jahr
Overview

Monte Rosa Therapeutics (MRT) seeks to recruit an enthusiastic, creative and highly talented scientist to join our growing CMC group in Basel supporting the discovery of molecular glue degraders (MGDs) that eliminate disease-causing proteins previously thought undruggable.

In this exciting role the successful candidate will contribute to all CMC tasks from discovery/preclinical stage to clinical and potentially commercial stage. This includes managing outsourcing activities for development and manufacturing of both drug substance and drug product and early phase formulation. Strong experience in process development of small molecule APIs, the desire to work in a fast-paced dynamic environment and excellent team working and cross-functional collaboration are critical in this role.

Responsibilities
  • Delivery of external drug substance and drug product including scale-up, manufacturing and material supply activities from preclinical phase onwards with high level of independence.
  • Synthesis & formulation assessment and design, trouble shooting, process and analytical development.
  • Contribute to the development and implementation of strategies to manufacture drug substance including process development, procurement of raw materials, phase appropriate analytical activities.
  • Management of timelines, resources and budgets.
  • On assigned projects, act as CMC lead and point of contact in cross functional project teams by participating in project meetings and provide regular updates.
  • Liaise with medicinal chemistry, toxicology and clinical teams to seamlessly advance our small molecule development candidates into preclinical & clinical development.
  • Manage physico-chemical and solid state studies of small molecule drug substances including polymorphism, solubility, early formulation studies, etc. to assess developability and formulation strategies for clinical development and commercialization.
  • Identify, select and manage appropriate Contract Development & Manufacturing Organizations (CDMOs) for appropriate process development work and for the GMP supply of drug substance and drug product.
  • Prepare, review, edit CMC regulatory and quality documents (batch records, analytical validations, reports and protocols).
  • Liaise with the regulatory team for drafting and reviewing documents for INDs and other regulatory submissions.
  • Responsible for drug supply chain in preclinical and clinical trials.
Qualifications
  • PhD or MSc in Organic Chemistry, Pharmaceutical Chemistry, Pharmaceutical sciences or related scientific discipline
  • 4-7 years of relevant  experience in the pharmaceutical or biotech industry in areas such as: process development, chemical or analytical development & scale-up, manufacturing (pilot or large scale), pre-formulation/formulation or CMC with small molecule drugs.
  • Sound knowledge of organic chemistry and process development of small molecule API.
  • Understanding of technical development needs from preclinical stage till clinical phases.
  • Experience of GMP manufacturing drug substances and/or drug products.
  • Experience of managing CDMOs and complex supply chains.
  • Other desirable experience: large molecule development and formulation; experience with different pharmaceutical dosage forms (e.g. tablets, capsules, parenteral, etc.), support of clinical development (Phase 1 through Phase 3) including IND, CTA and NDA filings; FDA and EMEA regulations are considered a plus.
  • Needs to be highly effective in cross-functional and cross-site teams
  • Flexibility, problem solving skills and ability to adapt to a highly dynamic environment.

  • Senior Scientist CMC, API

    Vor 4 Tagen

    Basel, Basel-Stadt, Schweiz Monte Rosa Therapeutics Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

    OverviewMonte Rosa Therapeutics (MRT) seeks to recruit an enthusiastic, creative and highly talented scientist to join our growing CMC group in Basel supporting the discovery of molecular glue degraders (MGDs) that eliminate disease-causing proteins previously thought undruggable.In this exciting role the successful candidate will contribute to all CMC tasks...

  • Senior/ Principal Scientist

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Roche Vollzeit CHF 120'000 - CHF 180'000 pro Jahr

    At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections,  where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure...

  • Senior Scientist

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Roche Vollzeit CHF 120'000 - CHF 180'000 pro Jahr

    JOB DESCRIPTION At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases...

  • Senior Data Scientist

    vor 9 Stunden

    Basel, Basel-Stadt, Schweiz Manpower Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

    **​** **MANPOWER AG – Your Career, Our Focus** Become part of our network and take advantage of countless opportunities ManpowerGroup is the leading global company for staffing solutions. With our three brands – Manpower, Experis, and Talent Solutions – we assist companies across various industries with their recruitment needs. For 75 years, we've...

  • Senior Safety Scientist

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz ELAN Personal AG Vollzeit CHF 120'000 - CHF 180'000 pro Jahr

    Senior Safety Scientist Background: Portfolio Safety Scientists (PCS-Sci) provide safety science and pharmacovigilance support to molecules across the Roche portfolio. As a group, they are responsible for all aspects of safety science/pharmacovigilance, with accountability being held by PCS leadership and experts or SSLs (Safety Strategy Program Leaders)...

  • Senior Data Scientist

    Vor 2 Tagen

    Basel, Basel-Stadt, Schweiz Gi Group Vollzeit $ 80'000 - $ 120'000 pro Jahr

    ROCGJP Period 01/02/2026 to 31/10/2026For our client F. Hoffmann – La Roche, we are looking for a dynamic team member for an exciting position:Senior Data Scientist - LiteratureF. Hoffmann – La Roche, BaselBackground:The Senior Data Scientist - Literature in the Safety Analytics and Reporting (SAR) group of the Safety Risk Management function (PDS)...

  • Applied/Senior Applied AI Scientist, Translational AI Lab

    vor 9 Stunden

    Basel, Basel-Stadt, Schweiz Roche Vollzeit $ 147'600 - $ 310'800

    A healthier future. It's what drives us to innovate. To continuously advance science and ensure everyone has access to the healthcare they need today and for generations to come. Creating a world where we all have more time with the people we love. That's what makes us Roche.Advances in AI, data, and computational sciences are transforming drug discovery and...

  • Senior Scientist, Machine Learning

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Roche Vollzeit CHF 120'000 - CHF 180'000 pro Jahr

    At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure...

  • analytical development scientist

    vor 2 Wochen

    Basel, Basel-Stadt, Schweiz Discover International Vollzeit CHF 120'000 - CHF 180'000 pro Jahr

    Job Title: Analytical Development - Quality Control ManagerWork Location: AllschwilCountry: SwitzerlandSchedule: Fulltime (100%)Desired start date: ASAPDuration: 12 MONTHSJob ResponsibilitiesAnalytical Development / Quality Control (AD/QC) is dealing with the analytical development of Drug Substance (DS) and Drug Product (DP). AD/QC must ensure that products...

  • Senior Expert

    vor 1 Woche

    Basel, Basel-Stadt, Schweiz Novartis AG Vollzeit CHF 65'060 - CHF 86'000 pro Jahr

    Senior Expert - Medical Device Analytical Representative (f/m/d) Job ID REQ Nov 19, Schweiz Summary #LI-Hybrid Internal job title: Senior Expert - Science & Technology Location: Basel, Switzerland or Schaftenau, Austria With the increasing diversity of Novartis' portfolio, the need for drug-device combination product analytical data packages is also...