CMC Manager, UK – Remote
Up to £60k + up to 20% annual bonus
- Responsible for the management of CMC development and commercial activities supporting the Pharma Business Unit. Accountable for the development, validation and transfer of analytical methods to the commercial facility and contract laboratories.
- Develop novel methodologies to support new and existing manufacturing processes
- Manage the negotiation, contracting and management of outsourced CMC activities, ensuring maximum productivity in terms of quality and cost for our client
- Lead and manage outsourced services to ensure best performance and business relationship (requiring both technical expertise and business acumen)
- Identify, assess and implement new suppliers into the outsourced supply chain
- Work with Legal to negotiate and implement new contracts (TA,s, Supply Agreements (commercial and development)) to add value to our clients portfolio
- Provide specialized technical CMC input to project teams including defining and implementing product development plan to ensure optimum target product profile is met and maximizing value to our client.
- Compile and/or assist Regulatory in compilation of CMC sections of all regulatory filings. Provide expert analytical advice with agency interactions, as required
- Support setting of budgets and ensure adherence to this budget throughout the financial year
- Ensure projects are delivered on time, in-line with all relevant guidelines, to budget, and in line with business needs
- Responsible for: Analytical Development Scientists.
WHAT YOU WILL NEED…
- Bachelors Degree with a sound technical background.
- 10 Years+ experience in pharmaceutical development and manufacturing.
- 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.
- Private Medical Insurance
- Bonus scheme & and much more