Assay Development Project Leader

Premier Recruitment Group Limited; Dartford; On-site; GBP 60,000 - 80,000; Full time

Job summary

A well-established recruitment agency is seeking an experienced Assay Development Project Leader in Dartford. This full-time position involves leading laboratory projects, verifying performance of immunoassays, and managing a team of scientists. Candidates should hold a science-based degree and have at least two years’ experience in immuno-diagnostic product design. The role offers great opportunities for progression within a reputable company.

Qualifications

• At least two years’ experience with immuno-diagnostic product design development or design change.
• Understanding of regulatory requirements for different sales markets for IVD products.

Responsibilities

• Plan and coordinate laboratory research as technical lead.
• Verify diagnostic performance of an immunoassay.
• Manage a small team of Product Development Scientists.
• Collaborate with Regulatory departments for drafting submission documents.

Skills

Interpersonal skills

Communication skills

Team leadership

Adaptability

Education

Science-based degree or relevant experience

Job description

Premier Recruitment Group has the privilege to recruit on behalf of our very prestigious client based in Dartford, Kent. We are recruiting for an experienced and forward‑thinking Assay Development Project Leader. This is a full‑time, permanent position working for a well‑established company, with a very interesting and varied role and room for progression.

Responsibilities

• Plan and coordinate laboratory research as technical lead or 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 Product Development scientists as a Team Leader.
• Coordinate and monitor, 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, meeting external and internal quality standards.
• Collaborate with Regulatory departments for drafting pre‑submission documents (pre‑IDE) and submission documents to notified bodies, as well as responding to questions from regulatory bodies.
• Liaise with other sites as the project portfolio requires.
• Complete all required documentation for completion of Product Design phases and Technical documentation.
• Escalate issues in project completion, budget, etc. in a timely fashion when required.
• Approach the role flexibly 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.
• Ability to adapt to quickly changing priorities.

To apply, contact Tom Kurczab at Premier Recruitment Group.