Companion Diagnostic Technical Lead

We are currently looking for a Companion Diagnostic Technical Lead to join an exciting Diagnostic business focused on using Proteomic data to identify predictive Biomarkers for drug response. This exciting new start-up is based in the Manchester area but can offer a range of flexibility for to secure the right CDx professional to lead the development of their RUO assay device.

You will be responsible for leading the commercialisation on an ELISA based device and advice on the pathway to approval.

This is an exciting opportunity to use your years of experience and knowledge to lead the Product Development in an a novel Biotech with Global Pharmaceutical links and partners!

KEY DUTIES AND RESPONSIBILITIES:

Your duties as the Companion Diagnostic Technical Lead will be varied however the key duties and responsibilities are as follows:

1. Represent product development in a matrix cross functional core team and be responsible for technical decisions and delivery within the project. This position could offer the chance to lead a team in the future as the company grows.

2. Leadership of all aspects of RUO/IUO/CDx assay development (assay, software, system) as well as defining user needs, kit requirements and specifications from customer inputs. You will also develop the RUO kits and verification and validation of claims.

3. Assay development leadership including supporting drafting and signing off of development study designs and reports in addition to creating design control documentation and running technical meetings.

4. Creation and maintenance, with QA, of the DHF ensuring compliance with industry standard ( ISO, 21 CFR part 820, IVDR).

ROLE REQUIREMENTS:

To be successful in your application to this exciting opportunity as the Companion Diagnostic Technical Lead we are looking to identify the following on your profile and past history:

1. Relevant degree in a Life Sciences Discipline and extensive experience in developing diagnostic assays under design controls.

2. Proven industry experience in Product Development where you have led the successful delivery of FDA (or similar) approved diagnostic kits as well as of stakeholder management; ability to communicate and tailor communication to the audience ( internal, external clients, regulatory authorities).

3. A working knowledge and practical experience with working in a regulated environment and quality process (QMS, technical file, DHF, Design control , ISO 13485).

Key Words: Companion Diagnostic | CDx | RUO | Research Use Only | IUO | Investigation Use Only | ELISA | Design Controls | Pathway Approval | Product Management | Product Development | ISO 13485 | FDA | ELISA | RPPA

Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer who are certified by Investors in People for talent development. We therefore welcome applications for any interested parties who fulfil the role requirements for this position. HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists. We look forward to helping you with your next career moves.