ClinLab Solutions Group
Pay Range
Base pay range: $70,000 – $90,000 per year. Compensation based on skills and experience. Job Summary
We are seeking an experienced and highly skilled Chemist III to support our Quality Control (QC) operations within a pharmaceutical manufacturing environment. This role requires expertise in analytical testing of finished products, raw materials, and stability samples, and experience in method development, validation, and transfer. The ideal candidate will possess advanced technical knowledge in HPLC, GC, and Chromatography Data Systems (preferably Empower 3), with strong troubleshooting and data analysis skills. As a Subject Matter Expert (SME), the candidate will oversee laboratory instrumentation, ensure compliance with cGMP and regulatory standards (USP, EP, JP, ICH, FDA), and contribute to continuous improvement in laboratory processes. This is a hands‑on role involving regular interaction with internal teams, contract laboratories, and cross‑functional partners to ensure timely and accurate testing and documentation in a dynamic, fast‑paced environment. Work Schedule: Monday – Friday 8:00 am – 4:30 pm. Qualifications
BS/MS in Chemistry or related scientific discipline with at least 4 years of pharmaceutical experience (or equivalent education and experience) in testing finished products, raw materials, and analytical method verification, validation, and transfer. Advanced technical skills in HPLC and GC, including theoretical understanding, troubleshooting, maintenance, and consumable replacements. Advanced level of Chromatography Data Software (CDS) preferably Empower 3. Ability to enable quantification for assays and impurity calculations, create custom calculations, and design chromatographic reports in CDS. Able to interpret data, including evaluation of stability testing for trends. Demonstrated use of analytical techniques in support of product development activities. Comprehensive knowledge of current Good Manufacturing Practices (cGMP), regulatory requirements, and ICH guidelines. Understanding and adherence to CFR 21 Part 11 requirements. Experience in raw material qualification of new incoming raw materials and annual review of existing raw materials. Comprehension and ability to follow procedures of various pharmacopeias (USP, EP, JP) and regulated guidance (WHO, FCC, FDA, ICH). Demonstrated ability to work well in a fast‑paced setting with teams. Self‑starter with a strong work ethic. Problem‑solving skills. Ability to operate with minimal supervision. Demonstrated ability to train and/or mentor employees. Excellent written and verbal communication skills. Responsibilities
Serve as the SME for analytical methods, instrumentation, and QC processes. Ensure proper calibration, maintenance, and troubleshooting of lab equipment. Assist and/or coordinate routine and non‑routine QC testing of raw materials, in‑process samples, stability, and finished products. Prepare and review SOPs, STMs, failure investigations, process deviation reports, stability study protocols/reports, instrument qualification protocols/reports, and analytical technical transfer protocols/reports. Interface with contract labs regarding QC sample handling and reporting. Maintain and ensure raw material qualification is completed for new and current raw materials; ensure annual testing completed per site procedures. Assist in implementing R&D methods, analytical method optimizations, method equivalencies, and validation/verification into the QC laboratory. Utilize QMS (Agile/Oracle) to initiate queries and change control documentation submissions. Evaluate and interpret test results and other related technical documentation. Assist in implementing LIMS system (Labware). Uphold all elements of data integrity; support audits (internal, customer, regulatory) and address findings. Perform other duties as assigned. Physical Requirements
Wear eye protection and lab coats while in the lab area. Follow OSHA regulations and company safety policies and procedures. Frequently lift and/or move up to 25 lb. Occasionally lift and/or move up to 35 lb. Regularly stand, sit, and walk while performing tasks. Additional Information
Seniority level: Mid‑Senior level. Employment type: Full‑time. Job function: Manufacturing, Analyst, and Quality Assurance. Industries: Pharmaceutical Manufacturing. Benefits: Medical insurance; Vision insurance.
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Base pay range: $70,000 – $90,000 per year. Compensation based on skills and experience. Job Summary
We are seeking an experienced and highly skilled Chemist III to support our Quality Control (QC) operations within a pharmaceutical manufacturing environment. This role requires expertise in analytical testing of finished products, raw materials, and stability samples, and experience in method development, validation, and transfer. The ideal candidate will possess advanced technical knowledge in HPLC, GC, and Chromatography Data Systems (preferably Empower 3), with strong troubleshooting and data analysis skills. As a Subject Matter Expert (SME), the candidate will oversee laboratory instrumentation, ensure compliance with cGMP and regulatory standards (USP, EP, JP, ICH, FDA), and contribute to continuous improvement in laboratory processes. This is a hands‑on role involving regular interaction with internal teams, contract laboratories, and cross‑functional partners to ensure timely and accurate testing and documentation in a dynamic, fast‑paced environment. Work Schedule: Monday – Friday 8:00 am – 4:30 pm. Qualifications
BS/MS in Chemistry or related scientific discipline with at least 4 years of pharmaceutical experience (or equivalent education and experience) in testing finished products, raw materials, and analytical method verification, validation, and transfer. Advanced technical skills in HPLC and GC, including theoretical understanding, troubleshooting, maintenance, and consumable replacements. Advanced level of Chromatography Data Software (CDS) preferably Empower 3. Ability to enable quantification for assays and impurity calculations, create custom calculations, and design chromatographic reports in CDS. Able to interpret data, including evaluation of stability testing for trends. Demonstrated use of analytical techniques in support of product development activities. Comprehensive knowledge of current Good Manufacturing Practices (cGMP), regulatory requirements, and ICH guidelines. Understanding and adherence to CFR 21 Part 11 requirements. Experience in raw material qualification of new incoming raw materials and annual review of existing raw materials. Comprehension and ability to follow procedures of various pharmacopeias (USP, EP, JP) and regulated guidance (WHO, FCC, FDA, ICH). Demonstrated ability to work well in a fast‑paced setting with teams. Self‑starter with a strong work ethic. Problem‑solving skills. Ability to operate with minimal supervision. Demonstrated ability to train and/or mentor employees. Excellent written and verbal communication skills. Responsibilities
Serve as the SME for analytical methods, instrumentation, and QC processes. Ensure proper calibration, maintenance, and troubleshooting of lab equipment. Assist and/or coordinate routine and non‑routine QC testing of raw materials, in‑process samples, stability, and finished products. Prepare and review SOPs, STMs, failure investigations, process deviation reports, stability study protocols/reports, instrument qualification protocols/reports, and analytical technical transfer protocols/reports. Interface with contract labs regarding QC sample handling and reporting. Maintain and ensure raw material qualification is completed for new and current raw materials; ensure annual testing completed per site procedures. Assist in implementing R&D methods, analytical method optimizations, method equivalencies, and validation/verification into the QC laboratory. Utilize QMS (Agile/Oracle) to initiate queries and change control documentation submissions. Evaluate and interpret test results and other related technical documentation. Assist in implementing LIMS system (Labware). Uphold all elements of data integrity; support audits (internal, customer, regulatory) and address findings. Perform other duties as assigned. Physical Requirements
Wear eye protection and lab coats while in the lab area. Follow OSHA regulations and company safety policies and procedures. Frequently lift and/or move up to 25 lb. Occasionally lift and/or move up to 35 lb. Regularly stand, sit, and walk while performing tasks. Additional Information
Seniority level: Mid‑Senior level. Employment type: Full‑time. Job function: Manufacturing, Analyst, and Quality Assurance. Industries: Pharmaceutical Manufacturing. Benefits: Medical insurance; Vision insurance.
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