Senior Analytical Method Transfer Scientist

Posted 4 April by RHL Easy Apply

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.

Analytical Quality Control Laboratory
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.

Job Title: Senior Method Transfer Analyst x2
Reference No: 238860
Location: Wiltshire
Job Type: Permanent
Salary: £27K-£34K plus benefits - 18 month Fixed Term Contract

Required skills

  • analysis
  • analytical
  • method validation
  • analytical methods
  • method verification
  • method transfer

Reference: 34824522

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