Senior Analytical Development Chemist

Placements24; Benoni; Hybrid; ZAR 650,000 - 950,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Professional growth

Job summary

Placements24 is seeking a Senior Analytical Development Chemist for its advanced R&D facility in Benoni, Gauteng. You will develop, validate and troubleshoot analytical methods for APIs and drug products, leading method development projects and collaborating with QA/regulatory teams.

You will work with HPLC/UPLC/GC, MS and spectroscopy to ensure quality, potency and stability, while aligning with ICH guidelines and cGMP.

Qualifications

• Master's or PhD in Analytical Chemistry or related field.
• 5–7 years of experience in pharmaceutical analytical development.
• Extensive hands-on experience with HPLC, UPLC, GC and spectroscopy.
• In-depth knowledge of ICH method validation principles.
• Familiarity with regulatory requirements for drug substances/products.
• Experience with LC-MS is highly desirable.
• Strong problem-solving and communication skills.

Responsibilities

• Develop and validate robust analytical methods for APIs and drug products.
• Perform method transfer to QC labs and external partners.
• Troubleshoot and optimize analytical methods for efficiency and sensitivity.
• Use instruments including HPLC, UPLC, GC, MS, UV-Vis, FTIR, KF titration.
• Investigate OOS results and deviations; write and review reports.
• Ensure activity in line with cGMP and regulatory standards.
• Stay updated on analytical tech and regulatory expectations.
• Provide mentorship to junior analytical chemists.
• Contribute to design of stability studies and interpretation of data.

Skills

Analytical chemistry

HPLC/UPLC/GC

MS & spectroscopy

Regulatory knowledge

Leadership

Communication

Education

Master’s or PhD in Analytical/Organic Chemistry

Tools

Mass spectrometry (LC-MS/GC-MS)

Job description

About the Role

Our client, a leading pharmaceutical company, is seeking a highly skilled Senior Analytical Development Chemist to join their state-of-the-art research and development facility in Benoni . This role is critical for developing, validating, and troubleshooting analytical methods used to characterize and control the quality of active pharmaceutical ingredients (APIs) and drug products throughout their lifecycle. You will leverage your expertise in various analytical techniques, including HPLC, GC, mass spectrometry, and spectroscopy, to ensure product purity, potency, and stability. The ideal candidate will have a strong background in analytical chemistry, a thorough understanding of regulatory guidelines (e.g., ICH, FDA, EMA), and a proven ability to lead method development projects. You will collaborate closely with formulation development, quality control, and regulatory affairs teams to support product registration and commercialization. This is an exceptional opportunity to contribute to pharmaceutical quality and innovation in Gauteng .

Key Responsibilities

• Develop and validate robust analytical methods for the characterization of APIs and drug products.
• Perform method transfer activities to QC laboratories and external testing partners.
• Troubleshoot and optimize analytical methods to improve efficiency, sensitivity, and specificity.
• Utilize a wide range of analytical instrumentation, including HPLC, UPLC, GC, MS, UV-Vis, FTIR, and KF titrators.
• Investigate and resolve out-of-specification (OOS) results and deviations.
• Author and review method development reports, validation protocols, and validation reports.
• Ensure all analytical activities are conducted in compliance with cGMP and other relevant regulatory requirements.
• Stay current with advancements in analytical technologies and regulatory expectations.
• Provide technical support and mentorship to junior analytical chemists.
• Contribute to the design of stability studies and interpret stability data.

Requirements

• A Master's or Ph.D. degree in Analytical Chemistry, Organic Chemistry, or a related field.
• A minimum of 5-7 years of experience in pharmaceutical analytical development.
• Extensive hands-on experience with HPLC, UPLC, GC, and various spectroscopic techniques.
• In-depth knowledge of method validation principles according to ICH guidelines.
• Familiarity with regulatory requirements for drug substance and drug product characterization.
• Experience with mass spectrometry (LC-MS, GC-MS) is highly desirable.
• Excellent problem-solving skills and meticulous attention to detail.
• Strong written and verbal communication skills, with the ability to present technical information effectively.
• Ability to work independently and manage multiple projects in a fast-paced environment.
• Experience with QbD (Quality by Design) principles is a plus.

Benefits

• competitive salary, comprehensive benefits package including health insurance and retirement savings, and ample opportunities for professional growth and skill development.
• flexibility of a remote work option combined with essential on-site laboratory work.