The Senior QC Chemist will be a critical member of the laboratory team responsible for analytical testing to ensure the quality, safety, and compliance of sterile injectable IV bag products at a newly established greenfield pharmaceutical manufacturing facility. This role will have a strong focus on analytical method verification, validation, transfer, implementation, and troubleshooting, while supporting routine QC testing and laboratory operations. The Senior QC Chemist will play a key role in establishing laboratory operations during the startup phase and supporting the transition to routine commercial manufacturing. The position requires hands-on experience with chromatographic and other analytical techniques, familiarity with Chromeleon CDS, Empower3 and a strong understanding of cGMP, data integrity, and laboratory investigation practices. The Senior QC Chemist will also coach, mentor, and train QC Chemists to ensure consistent technical performance and compliance.

Key Responsibilities:

Optimize, troubleshoot, verify, and validate analytical methods for raw materials, in-process samples, stability samples, packaging materials and finished products using techniques such as HPLC/UPLC, GC, UV-Vis, FTIR, TOC, AAS, KF titrator and other applicable analytical technologies. Support testing applicable to sterile IV-bag products, such as identification, assay, impurities, osmolality, particulate matter, TOC, density, Water Determination, and other physical or chemical attributes. Manage or support reference standards, reagents, volumetric solutions, laboratory consumables, sample inventory, instrument logbooks, and laboratory records. Execute and support analytical method validation, and verification activities, Support and execute analytical method transfers between R&D, QC, manufacturing, contract laboratories, and other sites Perform routine analytical testing and review results in accordance with approved methods, specifications, SOPs, Support analytical method lifecycle management, including method improvements, troubleshooting, change control, periodic review, and revalidation or reverification as required. Lead and/or support OOS, OOT, atypical result, and analytical deviation investigations, including laboratory investigations, root-cause analysis, assessment of method and instrument performance, and implementation of appropriate corrective actions. Prepare, review, and maintain analytical documentation, including methods, SOPs, verification/validation protocols and reports, method transfer documentation, COAs, deviations, OOS/OOT investigations, CAPAs, and change controls. Support laboratory startup and ongoing operations, including instrument qualification, calibration, maintenance, troubleshooting, and readiness of analytical equipment and laboratory systems. Ensure compliance with cGMP, FDA, USP, ICH, data integrity principles, and applicable global regulatory requirements, maintaining inspection-ready laboratory practices and documentation. Collaborate with Quality Assurance, Manufacturing, Validation, Regulatory Affairs, Process Development, Engineering, and external laboratories to support analytical method implementation, transfer, validation, investigations, product release, and commercialization activities. Coach, mentor, and train new QC Chemists on analytical techniques, method execution, laboratory procedures, and safe laboratory operations while contributing to continuous improvement and laboratory excellence. Qualifications /

Experience:

Bachelor's or master's degree in chemistry, Analytical Chemistry Pharmaceutical Sciences, or related field. 5+ years of experience in pharmaceutical QC laboratory, preferably in sterile injectable manufacturing. Strong hands-on experience with analytical instrumentation (HPLC, GC, UV, FTIR, KF etc.) and GMP-compliant laboratory operations. Knowledge of FDA cGMP regulations, USP standards, ICH guidelines, and data integrity expectations. Experience supporting laboratory investigations and regulatory inspections. Skills /

Competencies:

Strong analytical and problem-solving skills. High attention to detail and accuracy in laboratory work and able to coach others.. Solid understanding of data integrity and documentation practices and able to coach others. Ability to work both independently and as part of a team in a dynamic startup environment. Excellent organizational, time management, and communication skills. Ability to adapt to evolving processes and regulatory requirements in a greenfield manufacturing setting.