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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.
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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.
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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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