Senior QC Chemist

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

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 withChromeleonCDS,Empower3and 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 methodsfor raw materials, in-process samples, stability samples,packaging materialsand finished products using techniques such as HPLC/UPLC, GC, UV-Vis, FTIR, TOC,AAS, KF titratorand other applicable analytical technologies.

Support testing applicableto sterile IV-bag products, such as identification, assay, impurities, osmolality, particulate matter, TOC,density,Water Determination, and other physical or chemical attributes.

Manage or supportreference standards, reagents, volumetric solutions, laboratory consumables, sample inventory, instrument logbooks, and laboratory records.

Execute and support analytical methodvalidation,andverification activities,

Support and execute analytical method transfersbetweenR&D, QC, manufacturing, contract laboratories, and other sites

Perform routine analytical testingand review results in accordance with approved methods, specifications, SOPs,

Supportanalytical 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 maintainanalytical documentation, including methods, SOPs, verification/validation protocols and reports, method transfer documentation, COAs, deviations, OOS/OOT investigations, CAPAs, and change controls.

Support laboratory startupand ongoing operations, including instrument qualification, calibration, maintenance, troubleshooting, and readiness of analytical equipment and laboratory systems.

Ensure compliancewith cGMP, FDA, USP, ICH, data integrity principles, and applicable global regulatory requirements, maintaining inspection-ready laboratory practices and documentation.

Collaboratewith 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 trainnewQC Chemistson analytical techniques, method execution, laboratoryprocedures, andsafe laboratory operations while contributing to continuous improvement and laboratory excellence.

Qualifications / Experience:

Bachelor's or master'sdegree in chemistry, Analytical ChemistryPharmaceutical 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.

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.

Are you authorized to work in the United States? Are you authorized to work in the United States?

Will you now or in the future require sponsorship for employment visa status (e.g. H-1B status)? Will you now or in the future require sponsorship for employment visa status (e.g. H-1B status)?