Senior Specialist, Site Analytical Sciences

Job Description

Purpose of Role:

The Site Analytical Sciences Senior Specialist role is responsible for supporting Analytical Procedure Life Cycle through end-to-end method lifecycle management including introduction of new analytical methods, analytical transfers, SME assessment for all analytical method & equipment performance qualification, investigations, product testing and technical rationale. This work will support pipeline and commercial products by utilizing expertise in the analytical areas of separations and chemistry. 

Activities Within Role:

Technical expertise to support:

• New method introduction (Validation /Tech Transfer).

• New technology introduction.

• Assessment and implementation of changes for existing methods and equipment:

  • Change in technical element of method e.g. Parameter change

  • Change in equipment/material element of method e.g., column/reagent change.

• Method troubleshooting where cross-functional investigation is required.

• Technical SME for regulatory questions, audit support, reagent changes / supply issues to provide justification / rationale for analytical methods and equipment.

• Technical review of impact on Analytical methods and equipment as part of cross-functional team assessment of new/revised Global Test method / Compendia changes or updates.

• Management of PQ aspect of equipment qualification for all Quality Equipment, support IQ and OQ as required as part of capital projects.

• Analytical equipment troubleshooting.

• Initial training of end users in QC and Manufacturing and training of site analytical sciences personnel on lab systems, processes and methods where agreed.

• Investigation lead/support for lab investigations.

• Investigation lead for non-execution related investigations.

• Authoring technical documentation in support of investigation and regulatory responses.

• Analytical impact assessors on all QC Lab OPS change controls.

• Technical Impact Assessment of proposed and finalized compendial changes.

• Development and ownership of change control for new analytical methods.

• Routine Assay Monitoring and lifecycle management of analytical methods.

• Supporting digital method development.

Continuous Improvements:

Responsible for driving a culture of Continuous Improvement by deploying our company's Six Sigma tools

Key Behaviors:

• Win as one team.

• Focus on what matters.

• Act with urgency.

• Experiment, learn and adapt.

• Embrace diversity and inclusion.

• Speak Up and be open-minded

Educational and Experience Requirements:

• 3+ years (with PhD) or > 6 years (with MS) working on analytical method introduction and qualification within the biopharmaceutical and/or pharmaceutical industry.

•  Experience with analytical methods (HPLC, ICP, GC, NMR, Bioassays, compendial methods, cell-based assays)

• Flexible, self-motivated & ability to manage multiple priorities.

• Strong project management and stakeholder management skills required with demonstrated ability to influence across internal and external stakeholders.

•  Proven ability to work as part of an interdependent team but also on own initiative to ensure progression of priorities.

• Experience in problem solving (facilitation & application of tools), risk management, decision making & trouble shooting skills.

• Excellent communication skills – verbal, written, presentations.

• Ability to coach and support development of AS&T Scientists and QC technicians within AS&T and QC teams.

• Provide leadership and expertise for preparation of regulatory submissions, inspection readiness, and support health authority inspections – including but not limited to interaction with inspectors, responding to observations and monitoring of commitments.

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Required Skills:

Adaptability, Adaptability, Analytical Instrumentation, Analytical Method Development, Assay, Biochemical Analysis, Biopharmaceuticals, Business Management, Capital Projects, Cell-Based Assays, Chemistry, Decision Making, Detail-Oriented, Documentations, Driving Continuous Improvement, Forensic Chemistry, Good Manufacturing Practices (GMP), High-Performance Liquid Chromatography (HPLC), Laboratory Information Management System (LIMS), Laboratory