Senior QC Chemist: Method Validation & Startup Leader

Serovia USA Inc.; Branchburg Township (NJ); On-site; USD 90,000 - 130,000; Full time

Job summary

Serovia USA Inc. seeks a Senior QC Chemist to join a greenfield injectable manufacturing startup in the United States. You will lead analytical method verification, validation, transfer and troubleshooting, supporting routine QC testing and startup activities.

You will mentor QC chemists, ensure cGMP compliance, and drive data integrity across all analytical workflows while collaborating with QA, Manufacturing, Regulatory, and Process Development teams.

Qualifications

• Bachelor's or master's in chemistry, Analytical Chemistry, Pharmaceutical Sciences, or related field.
• 5+ years of experience in pharmaceutical QC laboratory, preferably sterile injectable manufacturing.
• Strong hands-on experience with analytical instrumentation (HPLC, GC, UV, FTIR, KF) 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.
• 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.

Responsibilities

• Optimize, troubleshoot, verify, and validate analytical methods for raw materials, in-process samples, stability samples, packaging materials and finished products using 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 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 QA, 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.

Job description

Serovia USA Inc. seeks a Senior QC Chemist to join a greenfield injectable manufacturing startup in the United States. You will lead analytical method verification, validation, transfer and troubleshooting, supporting routine QC testing and startup activities.

You will mentor QC chemists, ensure cGMP compliance, and drive data integrity across all analytical workflows while collaborating with QA, Manufacturing, Regulatory, and Process Development teams.