Premier Recruitment Group has the privilege to recruit on behalf of our very prestigious client based in Dartford, Kent. We are recruiting for experienced and forward-thinking Product Development Project Leader. This is full time and permanent position and working for very well established company. Very interesting and varied role with a scope for progression.
Responsibilities
- Plan and coordinate laboratory research as technical lead or as technical support for an assay development project.
- Verify the adequacy of diagnostic performance of an immunoassay.
- Act as interface with internal and external scientists and other departments.
- Coordinate the activities of the Product Development scientists as a Team Leader.
- Coordinate and monitors, in collaboration with the Project Co-Ordinator and Global Project Manager, the performance of assigned projects.
- Manage a small team of Product Development Scientists
- Assist with the preparation of the annual PD budget and forecasts
- Adhere to GOPs and SOPS as well as meeting external and internal quality standards.
- Collaborate with the Regulatory departments for the drafting the pre-submission documents (pre-IDE) and the submission documents to notified bodies as well as responding to questions from regulatory bodies.
- Liaise with other sites as the project portfolio requires.
- Completing all the required documentation for completion of Product Design phases and Technical documentation required.
- Escalate issues in project completion, budget etc. in a timely fashion when required.
- Approach the role in a flexible manner and be prepared to adapt to requirements outside of the immediate role that are essential to the organisation.
Skill requirements
- Science based degree or relevant experience desirable.
- Good interpersonal and communication skills.
- Ability to lead a team.
- Understanding of regulatory requirements for different sales markets for IVD products.
- At least two years experience with immuno diagnostic product design development or design change.
- The ability to adapt to quickly changing priorities.
If you are interested please apply directly or call Tom Kurczab at Premier Recruitment Group.