Associate Director/Director, Drug Product -CMC
Monte Rosa Therapeutics
Human Health and Social Work
4003 Basel, Basel-Stadt - Schweiz
Manager / Team Leader
Experteer Overview
As Associate Director/Director Drug Product CMC, you will lead formulation and drug product development for small-molecule MGDs from early development through commercialization. You will drive external manufacturing strategies, scale-up, and regulatory contributions within the CMC function, partnering with analytical, QA, regulatory, and clinical teams. You will oversee CDMO management and ensure robust supply strategies across the product lifecycle. This role offers the opportunity to shape DP development for a growing portfolio in a fast-paced biotech environment.
Responsibilities
- Develop formulation strategies for NCE MGDs, focusing on oral dosage forms
- Collaborate with drug substance teams to define development plans
- Supply DP via external vendors to support preclinical and clinical studies
- Lead tox formulation scale-up and material supply at external facilities
- Manage external vendors and CDMOs for process development and supply
- Lead scale-up, tech transfer, and formulation changes across development stages
- Define CPPs and quality attributes; oversee CDMO process validation
- Author/review CMC sections for IND/IMPD/MAA and contribute to regulatory submissions
- Represent CMC in cross-functional teams and coordinate DS/DP activities
- Manage timelines, resources, and budget; liaise with regulatory for submissions
- Partner with project teams to advance small molecule candidates into clinical development
Key requirements
- PhD or MSc with extensive experience in pharmaceutical or biotech DP development
- Experience in formulation science, process development, and scale-up for oral dosage forms
- Familiarity with regulatory expectations for CMC and QbD principles
- Experience with late-stage development, validations, and NDA filings
- Proven ability to manage CDMOs and complex supply chains
- Strong communication and leadership skills; cross-functional collaboration
- Ability to operate in a dynamic, fast-paced environment
Description
As Associate Director/Director Drug Product CMC, you will lead formulation and drug product development for small-molecule MGDs from early d…
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