Companion Diagnostic Technical Lead
- Employer
- Hyper Recruitment Solutions
- Location
- Manchester
- Salary
- £65000 - £75000 per annum
- Closing date
- 26 May 2021
View more
- Sector
- Biotechnology, Medical Devices, Quality Assurance, Regulatory Affairs
- Contract Type
- Permanent
- Hours
- Full Time
Job Details
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.
Company
Hyper Recruitment Solutions is a specialist and highly compliant recruitment consultancy dedicated to the Science and Technology sectors.
Hyper Recruitment Solutions (HRS), founded and run by Ricky Martin and in partnership with Lord Alan Sugar, has a wealth of recruitment expertise as well as compliance and commercial awareness. We offer a range of permanent, temporary and contract staff.
Our vision is to provide recruitment solutions which will assist in the improvement and quality of life for all. To do so, HRS will focus on the support of sectors whose primary focus is in making the world a better place. This could be working for a Pharmaceutical company who is developing new and existing therapeutics or an FMCG business who is making the latest consumer products in a sustainable and efficient way. We want to provide a service to those areas of actual need which will have an impact on us all.
We provide services across a broad range of industries including the following specialist sectors:
• Biotechnology
• Pharmaceutical
• Medical Device
• Clinical Research
• CMO / CRO
• Food / FMCG
• Engineering
• Science
With all jobseekers we are looking to form close relationships where we can offer you the most accurate and useful advice. We intend to not only find and present the most ideal career options to you, but we want to provide advice on the entire recruitment process. We are a business who listens and advises and as shown on our website we have a clear ‘candidate commitment’ to ensure your search is in the most professional and capable hands. Some of the key areas we focus on include:
• Quality Assurance (including Qualified Persons)
• Clinical Research (all phases and therapeutic fields)
• Bioinformatics
• Research & Development
• Consumer Insight and Sensory
• Lean and Continuous Improvement
• Engineering (all disciplines)
• Manufacturing, Scale up and Technology Transfer
• Packaging and Sustainability
• Medical Affairs
• Sales and Business Development
• Information Systems & Technology
• Executive Appointments
HRS has been awarded membership to the REC (Recruitment and Employment Confederation) and APSCo (Association of Professional Staffing Companies). This is to assure all clients and candidates that our processes and practices comply with all relevant government and recruitment industry regulations.
Lord Sugar, Ricky Martin and everyone at HRS look forward to working with you. Please do not hesitate to visit our website www.hyperec.com or contact us via
Telephone: 02032 255 120
Email:info@hyperec.com
Or any of the social media routes below:
Twitter
Facebook
Linked in
Google +
- Website
- http://www.hyperec.com/
- Telephone
- 0203 910 2980
- Location
-
Amshold House
Goldings Hill
Loughton,
Essex
IG102RW
GB
Get job alerts
Create a job alert and receive personalised job recommendations straight to your inbox.
Create alert