Technology Transfer and Manufacturing Manager
- Employer
- CK Group
- Location
- Abingdon
- Salary
- Competitive
- Closing date
- 20 Feb 2022
View more
- Sector
- Manufacturing
- Contract Type
- Permanent
- Hours
- Full Time
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Job Details
CK Group are recruiting for a Manufacturing and Technology Transfer Manager on behalf of a growing biopharmaceutical organisation, to be based at their site in Abingdon on a permanent basis.
You will be responsible for providing management of GMP manufacturing operations and providing technical expertise in the technology transfer of new products from Process Development Teams into the GMP Manufacturing Suite, ensuring all transferred processes are suitable for Phase I and Phase II clinical trials.
Your duties will include:
o Management of the daily operation of the GMP manufacturing suite
o Development of process control strategies to assist in gaining regulatory approval of new products
o Providing technical expertise in the technology transfer from CMOs
o Continuously supporting the manufacture of vaccine products through the execution of technical lifecycle management programmes aimed at improving and optimising manufacturing processes.
o Sourcing materials, consumables and process equipment suitable for manufacturing vaccines for Phase I and Phase II clinical trials
o Ensuring all procedures meet the current GMP requirements
o Generating training plans, work-based training packages and training out all operators
o Ensuring that equipment is qualified and within calibration, servicing, and qualification dates at all times.
o Supporting regulatory submissions and regulatory inspections.
o Authoring documents including SOPs, Technology Transfer Plans, Technology Transfer Reports, Batch Manufacturing Records, Material specifications, Process Risk Assessments, FMEAs, Gap analysis and Technical Reports
To be considered for the position you should have the following skills and experience:
o Substantial experience of working in a relevant GMP manufacturing environment.
o Experience in the operation of bioreactor vessels
o Experience in Tangential Flow Filtration (TFF)
o Previous experience of transferring products
For more information, or to apply for the position, please contact Sarah Farrow on 0191 3706486 or sfarrow@ckgroup.co.uk. Entitlement to work in the UK is essential for this role.
You will be responsible for providing management of GMP manufacturing operations and providing technical expertise in the technology transfer of new products from Process Development Teams into the GMP Manufacturing Suite, ensuring all transferred processes are suitable for Phase I and Phase II clinical trials.
Your duties will include:
o Management of the daily operation of the GMP manufacturing suite
o Development of process control strategies to assist in gaining regulatory approval of new products
o Providing technical expertise in the technology transfer from CMOs
o Continuously supporting the manufacture of vaccine products through the execution of technical lifecycle management programmes aimed at improving and optimising manufacturing processes.
o Sourcing materials, consumables and process equipment suitable for manufacturing vaccines for Phase I and Phase II clinical trials
o Ensuring all procedures meet the current GMP requirements
o Generating training plans, work-based training packages and training out all operators
o Ensuring that equipment is qualified and within calibration, servicing, and qualification dates at all times.
o Supporting regulatory submissions and regulatory inspections.
o Authoring documents including SOPs, Technology Transfer Plans, Technology Transfer Reports, Batch Manufacturing Records, Material specifications, Process Risk Assessments, FMEAs, Gap analysis and Technical Reports
To be considered for the position you should have the following skills and experience:
o Substantial experience of working in a relevant GMP manufacturing environment.
o Experience in the operation of bioreactor vessels
o Experience in Tangential Flow Filtration (TFF)
o Previous experience of transferring products
For more information, or to apply for the position, please contact Sarah Farrow on 0191 3706486 or sfarrow@ckgroup.co.uk. Entitlement to work in the UK is essential for this role.
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
Company info
- Website
- http://www.ckscience.co.uk/
- Telephone
- +44 (0)1246 457700
- Location
-
CK Group
Westwick House
The Bridge Business Centre
Beresford Way
Chesterfield
S41 9FG
GB
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