Senior Analytical Chemist - Pharmaceutical Analysis

Placements24; United States; Hybrid; USD 40,000 - 55,000; Full time

Job summary

Placements24 is seeking a Senior Analytical Chemist to join a fast-growing pharmaceutical QC/QA team in Welkom, Free State. You will develop, validate, and execute analytical methods for API identification and quality assessment using HPLC/UPLC, GC, UV-Vis, FTIR, and dissolution testing.

The role requires 5+ years in pharma analysis, strong knowledge of USP/EP/BP and ICH guidelines, data integrity, and collaboration with R&D and regulatory teams. Hybrid on-site and data analysis work offered.

Qualifications

• M.Sc. or Ph.D. in Analytical Chemistry, Pharmaceutical Chemistry, or related scientific discipline.
• Minimum of 5 years of experience in pharmaceutical analytical development & quality control with strong cGMP knowledge.
• Hands-on expertise with HPLC/UPLC systems and detectors (UV, DAD, FLD, MS).
• Experience with GC, KF titration, dissolution apparatus, and other analytical techniques.
• Thorough knowledge of pharmacopeial methods (USP, EP, BP) and ICH guidelines.
• Proficiency in data analysis, interpretation, and documentation.
• Strong problem-solving skills and attention to detail.
• Excellent communication and interpersonal skills; team collaboration.
• Experience with stability studies and method transfer is a plus.
• Must be based in or willing to commute to Welkom, Free State.

Responsibilities

• Develop, validate, and transfer analytical methods for identification, quantification, and purity assessment of pharmaceutical substances.
• Perform routine testing of raw materials, in-process samples, and finished products per specs.
• Operate and maintain analytical instruments ensuring calibration and GxP compliance.
• Investigate out-of-spec results and deviations; conduct CAPA.
• Prepare analytical reports, validation protocols, and validation reports.
• Stay updated on regulatory requirements and best practices in pharmaceutical analysis.
• Collaborate with R&D, manufacturing, and regulatory affairs to support product lifecycle.
• Contribute to continuous improvement of analytical procedures and lab operations.
• Train and mentor junior analytical chemists; maintain meticulous records.

Skills

Problem-solving

Attention to detail

Communication skills

Team collaboration

Education

M.Sc./Ph.D. in Analytical Chemistry or related

Tools

HPLC/UPLC

UV/DAD/FLD/MS detectors

GC

KF titration

Dissolution apparatus

Job description

About the Role

Our client, a dynamic and rapidly growing pharmaceutical company, is seeking an accomplished Senior Analytical Chemist to join their dedicated Quality Control and Assurance department in Welkom, Free State. This critical role involves developing, validating, and executing analytical methods for the characterization and quality assessment of pharmaceutical raw materials, intermediates, and finished products. You will be responsible for ensuring that all products meet stringent regulatory standards and internal quality specifications. The ideal candidate possesses extensive experience with a wide range of analytical instrumentation, a deep understanding of regulatory guidelines (ICH, FDA, EMA), and a meticulous approach to data integrity and documentation. This position offers a significant opportunity to contribute to the development and release of life-saving medications within a collaborative and innovative research environment located in Welkom. Our client is committed to upholding the highest standards of quality and scientific rigor.

Key Responsibilities

• Develop, validate, and transfer analytical methods for the identification, quantification, and purity assessment of pharmaceutical substances using techniques such as HPLC, GC, UV-Vis, FTIR, and dissolution testing.
• Perform routine testing of raw materials, in-process samples, and finished products according to established specifications and protocols.
• Operate and maintain a variety of analytical instruments, ensuring calibration and compliance with GxP guidelines.
• Investigate out-of-specification (OOS) results and deviations, conducting root cause analysis and implementing corrective and preventive actions (CAPA).
• Prepare comprehensive analytical reports, method validation protocols, and validation reports.
• Stay updated on current regulatory requirements and industry best practices in pharmaceutical analysis.
• Collaborate with R&D, manufacturing, and regulatory affairs departments to support product development and lifecycle management.
• Contribute to the continuous improvement of analytical procedures and laboratory operations.
• Train and mentor junior analytical chemists on laboratory techniques and instrumentation.
• Ensure meticulous record-keeping and data integrity in all laboratory activities.

Requirements

• M.Sc. or Ph.D. in Analytical Chemistry, Pharmaceutical Chemistry, or a related scientific discipline.
• Minimum of 5 years of experience in pharmaceutical analytical development and quality control, with a strong understanding of cGMP.
• Hands-on expertise with HPLC/UPLC systems (e.g., Agilent, Waters) and associated detectors (UV, DAD, FLD, ELSD, MS).
• Experience with GC, KF titration, dissolution apparatus, and other relevant analytical techniques.
• Thorough knowledge of pharmacopeial methods (USP, EP, BP) and ICH guidelines.
• Proficiency in data analysis, interpretation, and documentation.
• Strong problem-solving skills and attention to detail.
• Excellent communication and interpersonal skills, with the ability to work effectively in a team.
• Experience with stability studies and method transfer is a plus.
• Must be based in or willing to commute to Welkom, Free State.

Benefits

• Our client offers a competitive salary, annual performance bonus, comprehensive health insurance, and a retirement savings plan.
• This hybrid position allows for a blend of on-site laboratory work and remote data analysis/reporting.
• Employees benefit from professional development opportunities, including advanced training courses and conference attendance.
• The Welkom location provides a supportive community environment.
• We foster a collaborative work culture focused on quality and innovation.