Job Title:
R & D Manager - Clinical Diagnostics
Key skills:
Immunodiagnostics R&D
Location:
Cambridge
Duration:
Permanent
My client is developing a range of Distributed Clinical Diagnostics Systems and
is looking for an R&D Manager who, reporting to the VP of Operations (UK), will
be responsible for all aspects of Research and Development and Product Support
at the companies UK facility and in addition play a key role as an integral
member of the company's international R&D program based in the USA.
Key Responsibilities.
- Tactical management of all UK R&D programs.
- To provide product support for launched products.
- Communicating R&D project progress to the Project Director.
- Defining and implementing the highest standards for R&D. In particular
ensuring experimental work is carried out using appropriate statistical tools
and techniques and that all experimental conclusions are supported by data.
- Safety management of the R&D laboratory.
- Providing scientific communication to customers, partners and suppliers as
required.
- Representing the UK facility on the company's international project teams
as required.
- To act as the point of contact in the UK for the US Assay Development
team.
- To be a member of the UK site management team.
- To be responsible for the R&D teams budget and to provide information for
the companies budgeting process.
- To provide the relevant quality information for the companies quality
review process.
- Development and measurement of key performance monitors which will drive
ongoing departmental improvement.
- Identifying and evaluating novel technologies that will help the company
meet its strategic objectives.
- To ensure that all work carried out by the UK R&D group is carried out to
the defined regulatory standards are met by the UK R&D program (cGMP's and ISO
13485 2003).
Qualifications
A minimum of degree qualification or equivalent in Biochemistry, Clinical
Chemistry or another appropriate biological science.
Experience
Typically a minimum of 5 years experience in either Immunodiagnostics or
clinical chemistry assay R&D and or technical support.
3 years experience in a supervisory or management role.
Must be able to demonstrate a successful track record of bringing product to
the market.
Must be familiar with the design control process.
Key Skills and attributes
Highly developed analytical skills including design of experiments and
hypothesis testing.
Proven leadership and team building skills.
Strong communication skills.
Detailed understanding of the requirements of cGMP and ISO 9001 as applied to
the customer support, technical investigation and manufacturing environments.
Objective and data driven.
Functions well in short time scale environments.
Innovative in approach to problems.
General
Significant international travel will be
required (primarily to the US)
Please email a word version of your cv quoting Ref. No. 7b01a and call any time
+44 (0)20 8224 9006
Ref: 7b01a |