Senior Analytical Scientist - Method Transfer

Job Type:
Permanent
Job Sector:
Health, Medicine
Region:
South West
Location:
Wiltshire
Salary:
£27,000 to £34,000 per annum
Posted:
13/06/2018
Recruiter:
RHL
Job Ref:
240726/001

Our biopharma client is currently seeking a senior individual to manage and perform the transfer/ validation of analytical methods from development into a GMP environment.

The Analytical Quality Control Laboratory is responsible for provision of analytical chemistry services to support quality control testing of Biopharmaceutical products, raw materials and water systems. A stability study programme is also maintained.

JOB SUMMARY
The role involves all activities involved in transferring analytical methods from Development to QC Analytical Services including running analytical methods in both Development and QC Analytical Services, writing transfer/validation protocols, executing protocols in the laboratory, writing up the associated transfer/validation reports, performing release analysis and training existing members of staff in transferred methods.

MAIN DUTIES AND RESPONSIBILITIES
• Utilising technical skills to validate specialised chemical and biochemical tests procedures to internationally recognised regulatory guidelines. Conduct problem solving investigations to resolve issues affecting Pharmaceutical manufacture.
• Use technical expertise to be trained in and become a subject matter expert in methods being transferred.
• Manage all activities involved in transferring analytical methods from Development to QC Analytical Services including running analytical methods in both Development and QC Analytical Services, writing transfer/validation protocols, executing protocols in the laboratory, writing up the associated transfer/validation reports and performing release analysis.
• Perform release and stability testing of transferred methods.
• Train out analytical methods within a GMP environment.
• Work with project teams and represent QC on these to contribute to the success of these business centres by delivering the required Analytical knowledge and services.
• Maintain an up to date awareness of regulatory and scientific developments via approved training courses and meetings that will contribute to the efficiency and effectiveness of laboratory working practices and aid personal development.
• Authorship and review of SOPs, Protocols and Risk Assessments.
• Involvement in audits both from internal and external parties
• Write and review OOS investigations and deviation reports.

Contact Details:
RHL
Tel: 01233 658018
Fax: 01233 645702
Contact: Alex Butcher
Email:

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