I’m currently supporting a growing small molecule specialty pharmaceutical company with the appointment of a CMC Lead into a newly created, highly influential position.
The Role
You’ll take end-to-end ownership of CMC programmes across a portfolio of specialty pharmaceutical products, ensuring projects are delivered on time, to budget and in line with regulatory expectations.
Responsibilities include:
- Leading pharmaceutical development activities, including formulation, process development and analytical method development through to GMP readiness.
- Owning technology transfers from CDMO selection and qualification through validation, implementation and regulatory approval.
- Developing CMC strategies in collaboration with Regulatory, Quality and Commercial teams.
- Managing external CDMOs and technical partners, building strong relationships while ensuring technical excellence, quality and delivery.
- Driving manufacturing process improvements to enhance efficiency, product quality and supply reliability.
- Providing technical input into regulatory submissions, CMC documentation and lifecycle management activities.
- Managing project timelines, budgets, risks and governance across multiple development programmes.
About You
We’re looking for someone with significant experience leading CMC programmes within small molecule pharmaceutical development and manufacturing, who enjoys working in a fast-paced environment with a high level of ownership.
You’ll ideally bring experience across:
- End-to-end CMC programme leadership
- Pharmaceutical development and manufacturing
- Technology transfer and process validation
- CDMO selection, oversight and performance management
- Regulatory CMC submissions, variations and lifecycle management
- GMP manufacturing, quality systems and change control
If you’re looking for a role where you can combine technical expertise with strategic ownership, please do apply or feel free to reach out for a confidential chat to mr@Walkercole.com
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