We're seeking a Technical Lead for IVD assay development. This is a key role, based at our company in Ely and will suit someone looking to take that exciting next career step.
The role will suit a graduate (or postgrad) in life sciences/biomedical or similar subject with at least 3+ years of professional experience in in-vitro diagnostic assay development and validation.

OVERVIEW:

To be responsible for the daily management of technical projects and technical staff and the development of new products and the improvement of existing products in line with company strategy.

KEY RESPONSIBILITIES

To be responsible for the development of new products and the improvement of existing products in line with company strategy and customer requirements.
Daily management of technical staff including: setting objectives, organization of activities, technical assistance, HR, and health and safety.
Be responsible for the organization and planning of activities, projects, studies, and resources (human, budget, technical) for technical development activities.
To plan, design and perform/supervise experiments, interpret data, present results and exercise independent judgement for technical projects and investigations.
To contribute to the writing of relevant dossier sections for regulatory submissions and ensure technical compliance with recognised regulations and standards (CLSI guidelines, ISO standards, 21 CFR part 820, IVDR, UK-CA).
Be responsible for the planning, co-ordination, and prioritisation of all technical laboratory maintenance activities.
To work closely with the Head of Quality, the Chief Technical Manager and the Production Manager to create and manage production SOP’s.
To provide technical resource for Business Development in the introduction of new or enhanced products, and for the support of new and existing customers.
To provide technical resource to investigate customer complaints and product failures.
Collaboration with internal and external groups.

QUALIFICATIONS AND EXPERIENCE

Essential

Educated to degree level or equivalent with at least 3 years of professional experience in in-vitro diagnostic assay development and validation with a focus on some of the following: ELISA, autoimmunity/antibody-antigen based immunoassays, clinical chemistry, molecular diagnostics
Proven working in a regulated quality process (e.g., design control) and contribution to design history files; understanding of industry standards (e.g., CLSI guidelines, ISO standards 13485, ISO 14971, ISO 17025, ISO 9001 21 CFR part 820, IVDR)
Expert in data analysis and interpretation skills with knowledge of specific statistical tools an advantage
Excellent communication and presentation skills with a track record of tailoring communication to the target audience
Experienced in team management and leadership
Highly organised with a flexible, pro-active, self-motivated approach
Good coaching and mentoring skills

Desirable

A postgraduate degree such as MSc or PhD in a relevant subject (e.g. Biomedical Science, immunology, clinical chemistry)
Experience of external stakeholder management and/or customer partnering is highly desirable
Contribution to design history files
Understanding of industry standards (e.g., CLSI guidelines, ISO standards 13485, ISO 14971, ISO 17025, ISO 9001 21 CFR part 820, IVDR).

More info is available at https://clsdiagnostics.com/company/careers/

ABOUT Cambridge Life Sciences

Cambridge Life Sciences is a well-established clinical chemistry company based in Ely near Cambridge. We produce clinical diagnostics tests that are used for medical and research purposes, globally. We are part of a dynamic and fast-moving group. Following its acquisition in 2021, the company is now gearing up for significant expansion and growth into new fields of expertise within medical diagnostics.

We are an equal opportunities employer that provides a friendly, team-orientated working environment focused on providing our customers with the best possible products and highest level of service.