Head of CMC

Dependent on Experience
05 Mar 2019
02 Apr 2019
Georgina Beer
Contract Type
Full Time
We are currently looking for a Head of CMC to join a leading CRO company based in the Cambridgeshire area. As the Head of CMC Research and Development, you will be responsible for ensuring compliance with appropriate regulations, fulfilling service delivery according to contracts, recruiting and developing staff as well as maximising conversion of sales.


Your duties as the Head of CMC will be varied however the key duties and responsibilities are as follows:

1. You will be working closely with different departments within the company, including Sales, Finance, Marketing and Senior Management, to identify strategic growth and development opportunities for the department.

2. It will be your responsibility to authorise Study Project Plans, Study Protocols and Analytical Plans as a key member of Management.

3. You will maintain an awareness of the competition within the marketplace and act accordingly for the CMC department by including commercial and service expectations. You will then ensure your staff maintain an up-to-date knowledge of scientific advancements and developments within their relevant fields.

4. It will be necessary for you to adhere to regulatory guidelines and industrial expectations, responding to these by implementing appropriate procedures, organisation, training and documentation.

5. You will develop the CRO's brand, be the lead contributor to meetings with client companies when they visit the site and ensure a quality service is provided by the department.


To be successful in your application to this exciting opportunity as the Head of CMC we are looking to identify the following on your profile and past history:

1. A PhD in a relevant biological or chemical subject (e.g. Biology, Chemistry, Biochemistry, Pharmaceutical Sciences, etc.) or equivalent industrial experience is required for this position.

2. Extensive industry experience in biological drug discovery or early phase biopharmaceutical development is necessary for this position. Previous work in a regulatory environment is also required, preferably within GMP.

3. A working knowledge and practical experience with leading a Research and Development Team and acting as a Line Manager is necessary for this position.

4. An ability to understand and use financial and operational data and metrics will be highly beneficial for this position as The Head of CMC.

Key Words: CMC / Chemistry / Manufacturing / Controls / Biologics / Pharmaceutical / Biopharmaceutical / Head of Department / Line Management / Team Leader / Research and Development / GXP / GMP / Health and Safety / Regulatory / Scientist /

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.

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