GMP Project manager – Cell potency and Molecular
Job description
We need you to have:
- Project management of GMP regulatory studies
- Technical specialism in Cell based bioassays
- Expertise in ICH Q2 R1 analytical method validation
- Good understanding of Flow cytometry assays
- Experience Molecular and Immunoassay is advantageous
- IT literacy and numeracy skills with the knowledge of calculating and tabulating results
ABOUT THE OPPORTUNITY
As a Project Manager in our bioassay team, you will have overall responsibility for the scientific, administrative, and regulatory conduct of GMP studies in a GxP laboratory. You will demonstrate your expertise in a range of analytical techniques including Cell-based bioassays
- Overseeing validation studies in accordance Intertek procedures based on ICH Q2 R1 regulatory guidance.
- Good technical understanding of flow cytometry
- In addition, experience of molecular assays (qPCR/ddPCR) and immunoassays is advantageous
- Preserving data integrity ensuring all data are accurately and fully documented following ALCOA plus principles and computerised systems are validated and fit for use in the study
- Recording and resolution of deviations impacting study conduct
- Ability to produce high quality reports, as a complete, true and accurate record of study conduct and conclusions
- Effective and enthusiastic communication with customers from a range of industries.
- Understanding of capabilities of other teams within the business and wider C&P environment.
- Skilled project management, including ability to generate / edit multi-technique reports.
- Able to define projects customer requirements, manage and deliver multi-technique projects.
- Ability to manage and report projects, drawing on findings from several techniques with technical support to solve customer problems.
WHAT WE OFFER
Join Intertek and become part of our global network of inspiring and entrepreneurial colleagues. We are a global family that values diversity and we thrive working together with precision, pace and passion. We are working to make the world Ever Better, ensuring the quality, safety and sustainability of products and services used by millions of people around the world.
- Competitive salary/benefits
- Development and career opportunities around the Globe
- Working in a highly motivated team and dynamic working environment
In this opportunity you’ll be joining our Bioassay Cell potency team, based at Intertek Pharmaceutical Services Manchester (IPSM), Blackley Manchester
We are an Equal Opportunity Employer who do not discriminate against applicants. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex or national origin.
Intertek operates a preferred supplier arrangement and we do not accept unsolicited approaches from agencies.
