I am recruiting for an Analytical Scientist who has a strong background in Chromatography method development and transfer. The successful candidate will provide analytical support to MS&T for process optimisation and/or change, analytical support to commercial manufacture and quality control for unplanned events / OOS investigations. To validate/transfer analytical methods developed and lead the reference standard manufacture and assignation.
Pharmaceutical industry experience supporting manufacturing is a requirement for this position, research experience will not be sufficient.
Responsibilities
Ownership of analytical Test Methods lifecycle: development, validation, transfer, use & monitoring; including periodic performance reviews, test results track & trend, continuous improvement, change controls, and retirement
Lead the development and validation of robust analytical methods in line with current guidelines for raw material, intermediate, in-process, API and finish product methods. These projects may focus on current commercial processes or new chemical entities under transfer to commercial organization.
Ensure high-quality documentation including laboratory notebooks, technical reports, SOPs, and validation documents.
Lead analytical method transfers to internal manufacturing, QC laboratories, or external partners, ensuring successful execution and technical alignment
Lead projects for the identification of unknowns - for example, use of LCMS applicable methods etc.
Serve as SME for key analytical technologies (HPLC/UPLC, GC, LC-MS, ICP-MS, FTIR, titration, particle size etc.) and ensure equipment qualification, maintenance, and calibration.
Evaluate and implement emerging analytical technologies, automation, or digital tools to increase analytical capability, efficiency, and data reliability.
Identify opportunities to enhance method performance, reduce testing cycle times, and support operational excellence initiatives.
Provide analytical support for deviations, OOS/OOE events, root-cause investigations, and CAPAs.
Coordinate lifecycle of Laboratory Assets, including projects & procurement to introduce new technologies, change controls, calibration/qualification, maintenance, and asset retirement.
Provide technical and scientific leadership to other team members including providing assistance in study design. Provide training/coaching to junior scientists.
Ensure Compliance with site EHS systems and procedures e.g. Permit to work Systems, Incident/Accident Investigation procedures, risk assessments etc.
Ensure participation in relevant EHS unplanned events and ensure accidents/incidents are investigated in a timely manner as assigned by area supervisor
Ensure attendance at EHS training modules as defined by the site training calendar and that high standards of housekeeping are maintained in the area
Ensure closure of EHS actions raised from accidents/incidents, audits, risk assessments etc are managed and closed in a timely manner.
Responsibilities in the above role are not limited to those described and may evolve or change from time to time.
Qualifications & Experience
PhD or MSc In Science (Analytical focused) or technically related discipline or BSc. In Science (Analytical focused) or technically related discipline
3 - 5+ years relevant experience working within a GMP/GLP environment
Experience in method development, method transfer and method validation is essential for this role.
In depth knowledge of analytical chemistry in particular Chromatography, knowledge of biochemistry techniques (SDS-PAGE, ELISA) an advantage.
Proven experience of method development of identity and purity assays desired.
Ideally experience in leading projects for biopharmaceutical products including method validation
Proficiency on technical operating systems (including LIMS, Minitab Empower, Veeva, Quality Connect) Proven problem solving and troubleshooting abilities
Ability to independently perform root cause analysis for method investigations Proven ability in technical writing skills
Time management and project management skills
Experience of technical supervision or leading scientific projects.
Proficiency in the use of statistics to understand data.
Ability to work in a collaborative work environment with a team Ability to train junior staff
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