Specialist, Quality Control Execution Support; 2nd Shift

The Quality Control Execution Support Specialist role (2nd shift) is responsible for supporting Analytical Procedure Life Cycle through end-to-end method lifecycle management including introduction of new analytical methods, act as the receiving unit for 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, biochemistry, and microbiology.

Technical expertise to support:

• New method introduction (Direct to QC Validations /Tech Transfer Receiving Lab Support).
• 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 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 provided 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.
• 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 support for lab 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 updates to analytical methods.
• Routine Assay Monitoring and lifecycle management of analytical methods.
• Supporting digital method development.

Responsible for driving a culture of Continuous Improvement by deploying our Company Six Sigma tools Coaching and Training:
The Analytical Sciences Team Lead will provide support, guidance, and expertise to ensure the success of the Analytical Sciences group; will model our Company Leadership behaviors and understand the MPS principles to drive a culture of continuous improvement building a High-Performance Organization.

West Point Site Analytical Sciences, Quality Control Execution Lead

• Win as one team.
• Focus on what matters.
• Act with urgency.
• Experiment, learn and adapt.
• Embrace varied perspectives and inclusion.
• Speak Up and be open-minded

• Bachelor's degree (1-3 years related work experience) or Master's degree (0 years related work experience) – in Chemistry, Biology, Microbiology or related field.

• 1+ years working on analytical method introduction and qualification within the biopharmaceutical and/or pharmaceutical industry.
• Experience with analytical methods (HPLC, cGE, ELISA, Bioassays, PCR, compendial methods, Microbial 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…