CMC Leader – Drug Product (Solids) Development | Contract |
We’re seeking an experienced CMC Leader with deep expertise in solid oral dosage forms to lead drug product development activities for a late-phase small molecule program
Key Responsibilities
* Lead CMC strategy and execution for a late-stage oral solid drug product (capsule-to-tablet transition).
* Represent CMC in cross-functional project teams and align on development and clinical supply plans.
* Oversee external vendors for formulation development, scale-up, and GMP manufacturing.
* Review and approve technical documentation (development reports, batch records, protocols).
* Monitor and interpret stability data; adjust formulation or shelf-life strategy as needed.
* Prepare and archive regulatory documentation; support responses to Health Authority queries.
* Contribute to due diligence activities as required.
Your Profile
* MSc or PhD in Pharmaceutical Sciences, Chemistry, Bioengineering, or related field.
* 6+ years of experience in drug product development, with strong expertise in solid oral formulations .
* Proven track record in late-stage development and external vendor management .
* Strong communicator with experience in cross-functional collaboration and regulatory documentation.
* Hands-on, pragmatic, and quality-focused.