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 Assay 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.

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