Project Manager GLP/GCP

North West
Not specified
Sep 08, 2016
Sep 29, 2016
Jacob Golding
Result Type
Position Type
Full Time

SALARY:      Competitive  (dependent on experience)
LOCATION:  Manchester
CONTRACT: Permanent
HOURS:        Full Time - Mon-Fri

  • To perform the role and responsibilities of Project Manager / Coordinator, this will include acting as a GLP Study Director, GCP Responsible Scientist and/or GMP Project Manager for regulatory studies conducted on behalf of customer businesses.
  • To develop, validate and apply analytical methods based upon Immunochemistry and cell based assays AND/OR chromatographic separation.

Typically the key job accountabilities will include but not limited to:-
  •  Develop and apply both existing and new methods to support research, product development and registration within the customer contract businesses.
  •  To act as Project Manager / Study Director on customer sponsored GMP, GCP and GLP regulatory studies, intended for submission to government agencies worldwide. Responsibilities include but are not limited to:- planning, defining and scheduling the analytical programme and for the overall technical conduct of the study, taking full responsibility for the overall compliance of the study and all associated data.
  •  To be responsible for proactively managing the customer interface is key accountability as is - driving preparing and signing off study protocols etc, and ensuring that customer contacts and project/study sponsors are kept fully informed and up to speed with progress / difficulties / additional costs etc.
  •  Contribute to and where appropriate lead cross functional teams to devise, develop and apply analytical technology to solve analytical problems arising in the customer contract businesses.
  •  Liaise with other groups within the company, customer businesses to provide a detailed chemical knowledge of both new and existing products.
  •  In conjunction with the Group Leader manage the day to day activities of personnel in the Team, to ensure that the needs of the contract customer businesses are met, and that the teams activities are fully recorded and reported.
  •  Train and coach junior members of the Team in analytical techniques and procedures as appropriate.
  •  To ensure that all analytical work and support activities are performed in accordance with Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and Good Manufacturing Practice (cGMP) and ensure compliant recording of all experimental data.
  •  Produce and contribute to Technical Reports, and report analytical data, results and conclusions directly to the customer businesses, and ensuring that good lines of communication are maintained throughout the analytical process.
  •  Work strictly to the COSHH regulations observing company and SHE policies to ensure safe and optimal working conditions at all times and ensure that all equipment is in maintained in good working order.

  • A relevant degree in science.
  • At least 5 years experience, and broad knowledge of immunochemistry AND/OR analytical chemistry.
  • Leadership skills
  • Previous knowledge and experience of cGMP Project Management, GCP Responsible Scientist and/or of a GLP Study Director role and responsibilities are essential
  • A proven track record of effective and efficient project delivery is also essential.

Required Skills and Knowledge
  • Ability to devise, price and carry out a programme of work containing both long and short term goals, interpret results and suggest new areas of work in order to meet agreed targets
  •  Effective time and work management
  •  Full understanding and enforcement of relevant quality procedures
  •  Ability to extend knowledge to meet specific research areas
  •  Sound scientific method development and problem solving skills
  •  Leadership, supervisory and coaching skills
  •  SHE knowledge and application of procedures and audits
  •  Communication and customer care skills

If you feel that you have the experience and skills that match the above criteria then please get in touch.
For further information contact:  Jacob Golding  -  0161 839 2400