ProcessChemist

## **Job Description** * 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. ## ## **Qualifications** **Qualification