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Vice President/Head of CMC

Employer
CK Group
Location
Woburn
Salary
Competitive
Closing date
16 Sep 2021

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Job Details

CK Group are recruiting for a Vice President of CMC to join a growing clinical-stage biotech company who are focused on improving the lives of patients facing life threatening disease with the next generation of antibody therapies.

Our client based in Woburn, Massachusetts and are looking to recruit a VP of CMC on a permanent basis.

Vice President of CMC Role:

The Vice President, CMC will be responsible for all CMC activities, as well as, all outsourced contract manufacturing for programs in different stages of development ranging from GLP toxicology materials to Phase 1 to Phase 2 clinical trial material and commercial drug products.

Further duties include to:
  • Establish and oversee the implementation of the overall CMC strategy for all stages of programs ranging from preclinical GLP studies through Ph3 clinical trials.
  • Review CMC project plans and timelines and assist in execution to ensure all projects are appropriately prioritized and key goals are met on time.
  • Develop and maintain an in-depth knowledge of drug product manufacturing and development technology; and the associated regulatory requirements.
  • Author and review CMC regulatory submissions.

Your Background:
  • Advanced degree in Engineering, Pharmaceutical Sciences, or related field.
  • Extensive experience with development and optimization of manufacturing processes and oversight of manufacturing campaigns for supplies ranging from GLP toxicology supplies to cGMP Phase 3 clinical trial material.
  • A strong understanding of CFR Parts 58, 210, and 211; ICH; and FDA regulatory guidance related to pharmaceutical development, manufacturing and specifications is required.
  • Previous extensive experience in management of process development and drug product manufacturing is required.

Apply:
For more information or to apply for this Vice President/Head of CMC position, please contact Alex Tosney by email at atosney@ckgroup.co.uk, quoting job ref 51405.

It is essential that applicants hold entitlement to work in the USA.

Company

Find the career you always dreamed of

We are the CK Group, the UK’s specialist in scientific, clinical and technical recruitment.

We have 4 brands:  

  • CK Science is the leading independent scientific recruitment consultancy.
  • CK Clinical is an established leader in the clinical research and drug development sectors
  • CK Technical specialises in jobs for Engineers and IT professionals
  • CK QLS finds roles for high calibre professionals working in the science and technology sectors in Switzerland.

Over the last 28 years we have found jobs for thousands of high calibre scientists in the scientific, chemical, waste, biotechnology and pharmaceutical industries. By working with us to find your next job, you will get access to the best scientific vacancies in the UK, Europe and the rest of the world.

We are proud to be working with 18 out of the world’s top 20 scientific organisations.

We can help you find your dream job.

ckscience.co.uk

Find Us
Website:
Telephone
+44 (0)1246 457700
Location
CK Group
Westwick House
The Bridge Business Centre
Beresford Way
Chesterfield
S41 9FG
GB
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