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Analytical Development Leader

Job Title: Analytical Development Leader
Contract Type: Permanent
Location: Staffordshire
Industry:
Salary: £35000 - £40000 per annum + company benefits
Start Date: 01/04/17
Reference: 68996-PHARM-JHY_1490115589
Contact Name: James Harvey
Contact Email: James.Harvey@volt.eu.com
Job Published: March 21, 2017 16:59

Job Description

Job title: Analytical Development Leader - Quality Operations
Job type: Permanent
Location: Staffordshire, UK
Salary: £35,000 - £40,000 / year + company benefits

SUMMARY

- My client is a leading international clinical and commercial manufacturer of
biologics and pharmaceuticals, offering a broad range of integrated and stand-
alone development services
- They are renowned for manufacturing excellence and being a trusted provider,
delivering on their promises and helping customers to develop drugs for the
benefit of patients

THE ROLE

- I am currently looking to recruit for them an Analytical Development Leader
within their UK Quality Operations group
- The successful candidate will be responsible for all Analytical aspects relating
to method development, evaluation, qualification / validation and transfer for
assigned Projects

DAY TO DAY DUTIES

- Responsibility for scientific development and evaluation of analytical methods,
including identification and implementation of new assays to meet the developing
needs of the business
- Working with technical leads, multidisciplinary teams and clients to determine
the optimal technical and scientific approach for ensuring the efficient
progression of assigned programmes
- Accountability for the scheduling, management and execution of the analytical
support to deliver assigned programmes of work
- Line management responsibility for a team of analytical development analysts
- Responsibility for method transfer both internally and externally
- Method qualification / validation
- Support of Commercial activities and for working closely with Project
Management

REQUIRED SKILLS & EXPERIENCE

- Extensive analytical development experience
- A proven track record in assay development and validation is essential
- Broad knowledge of analytics application for both final product and in process
samples types with the ability to confidently interpret data, reach sound
scientific conclusions, present, discuss and defend data / scientific direction
internally, to academic groups and to clients
- Understanding of method requirements as per Regulations such as ICH and EU GMP
- Ability to work independently with limited supervision, owning the scientific
direction of their work as well as interacting with academic groups
- Ability to solve complex problems
- Ability to demonstrate strong written and oral communication skills
- Line management experience

EDUCATION REQUIREMENTS

- Degree in Biochemistry, Virology, Biotechnology, or other appropriate science
and a minimum of 5 years of relevant postgraduate experience preferably in part
within an industrial environment

OTHER REQUIREMENTS

- Highly motivated, and demonstrate strong working knowledge of multiple product
types, including trouble shooting capabilities, in vitro cell-based methods,
QPCR and immunoassay techniques
- Practical experience of assay development and/or assay validation is essential
- Ideally, will have previously published work in peer reviewed scientific journals