- This position will be responsible for qualification of analytical methodology for product pipeline .This role extends to implementing analytical methodology in to the Analytical, Biochemistry/Cell Biology, Micro Laboratories within QC and Manufacturing and including but not limited to cutting edge PAT/ Rapid Testing Methodology
Core Duties and Responsibilities:
- Act as Technical expert to support new method introduction & continuous analytical innovation in the Laboratories & Manufacturing
- Coordinate Analytical Method Qualification and execute acGMP compliant &timely qualification into QC & Manufacturing to support the commercialization pipeline.
- Act as local Subject Matter Expert (SME) for AS&T business processes including Analytical Method Validation, Analytical Technology Transfer.
- Provide Technical support to Analytical Investigations during qualification & routine use of Methodology
- Support the implementation of Analytical Robustness program to support commercialization & the life cycle of the analytical methodology.
- Liaise with Global Centre of Excellence to support analytical method qualification, implementing new technology.
- Provide support & expertise for the preparation of regulatory submissions, inspection readiness activities, during health authority inspections including interaction with inspectors, responses to inspection observations & monitoring of follow up actions.
Minimum Qualifications and Experience:
- MSc minimum, PhD preferred in a technical discipline (Biochemistry, CellBiology, Analytical Science)
- 2-4years working in a relevant role within the Biopharmaceutical and/or Pharmaceutical industry
- Flexible, self-motivated & ability to manage multiple prioritie
- Proven ability to work as part of a team but also on own initiative to ensure progression of priorities.
- Experience in problem solving (facilitation & application of tools), riskmanagement, decision-making & troubleshooting skills
If you would like to discuss this vacancy or to discuss your career and other job opportunities in confidence, contact us:
Please note, we do not require agency assistance with this role.