Execute and oversee complex laboratory work, primarily GC, with complementary techniques (e.g., LC, LCMS, GCMS) to enable timely, customer‑focused decision making in a manufacturing environment. Provide on‑floor and real‑time troubleshooting as needed, prioritizing work to meet manufacturing schedules and ensuring timely, right‑first‑time resolution of analytical questions. Design and execute statistically sound experiments (including DOE where appropriate), interpret complex datasets, and communicate clear, risk‑based recommendations to manufacturing and quality stakeholders. Lead process performance evaluations, robustness studies, and root cause analysis to support deviations, CAPA, complaints, and lifecycle improvements. Partner cross‑functionally with QC, QA, R&D, MSAT, and Global Operations to align analytical strategy with product requirements, control strategies, and operational priorities. Lead and support complex investigations related to manufacturing events and customer complaints, applying structured problem‑solving methodologies to determine root cause and implement effective corrective and preventive actions. Drive continuous improvement of chromatography capability, including equipment and instrument performance, preventative maintenance strategies, method robustness, and technical engagement with vendors as required. Author, review, and approve high‑quality technical documentation (e.g., protocols, validation and transfer reports, deviations/investigations, change controls), ensuring traceability, compliance, and data integrity. Provide technical leadership through mentoring and coaching, influencing cross‑functional teams and driving adoption of best practices in chromatography and laboratory execution. Ensure all work is performed in compliance with safety, quality, and regulatory requirements, with a strong focus on good documentation practices and data integrity.
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Job Type
Full-time
Career Level
Senior