CMC Process Development Manager, Ceredigion, West Wales
Pharmaceutical industry
Potentially hybrid (3 days on site minimum)
Up to £60k + up to 20% annual bonus
THE DUTIES…
- Lead process development actions for current products and for the introduction of new products, optimisation of the manufacturing process including formulation, scale up and technical transfer from R&D to Production.
- Guide the design and execution of experimental plans to understand the process and its robustness (Identification and characterisation of Critical Process Parameters and of Critical Quality Attributes).
- Complete process characterisations studies (e.g. viral clearance studies, resin reuse, process limit evaluations).
- Provide specialised technical CMC input to project teams
- Work with Legal to negotiate and implement new contracts (TA,s, Supply Agreements (commercial and development)) to add value to our clients portfolio.
WHAT YOU WILL NEED…
- Bachelor’s Degree with a sound technical background.
- 10 Years+ experience in pharmaceutical development and manufacturing desirable.
- 5 Years+ experience of managing vendors.
- Excellent understanding and hands–on working knowledge of cGMP, quality and regulatory requirements for clinical and commercial material.
- Demonstrated ability to successfully manage outsourced manufacturing and analytical contractors.
- Drives / access to own vehicle (due to location)
BENEFITS..
- Beautiful location
- 25 annual leave days plus bank holidays and 3 annual company closure days (to be taken between Christmas and New year)
- Private Medical Insurance
- Bonus scheme & and much more!
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