Senior Analytical Development Scientist - Pharmaceutical

Placements24; Bloemfontein; Hybrid; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Health coverage

Life assurance

Retirement savings plan

Professional development

Job summary

Placements24 partners with a leading pharmaceutical research organization in Bloemfontein to appoint a Senior Analytical Development Scientist. You will develop and validate analytical methods (HPLC/UPLC, GC, UV) for drug substances and products, perform method transfers, and support stability programs and regulatory submissions.

The role requires PhD or MSc in Analytical Chemistry or Pharmaceutical Sciences, 5+ years’ experience, and a strong focus on data integrity, GLP/cGMP, and collaboration

Qualifications

• PhD or MSc in Analytical Chemistry, Pharmaceutical Sciences, or related field.
• Minimum 5 years in pharmaceutical analytical development.
• Extensive hands-on with HPLC, UPLC, GC and spectroscopic methods.
• Proven experience in method validation per ICH guidelines.
• Strong data analysis, interpretation and scientific writing skills.

Responsibilities

• Develop and validate analytical methods (HPLC, UPLC, GC, UV) for drug substances and products.
• Transfer methods to QC laboratories and provide ongoing support.
• Conduct forced degradation and stability indicating studies.
• Analyze raw materials, in-process samples and finished products to ensure specifications.
• Troubleshoot analytical issues and ensure data integrity and timely results.
• Interpret data and author reports, protocols, and validation summaries.
• Contribute to regulatory submissions with analytical data and method descriptions.
• Collaborate with QA, formulation development, process chemistry, and regulatory teams.

Skills

HPLC

UPLC

GC

Spectroscopy

ICH method validation

Drug characterization

Education

PhD or MSc in Analytical Chemistry/Pharmaceutical Sciences

Tools

LIMS

ELN

Job description

About the Role

Our client, a leading pharmaceutical research organization, is seeking a highly skilled Senior Analytical Development Scientist to join their cutting-edge laboratory in Bloemfontein, Free State . This crucial role focuses on the development, validation, and implementation of robust analytical methods for pharmaceutical products and raw materials. The ideal candidate will possess a deep understanding of various analytical techniques and their application in drug substance and drug product characterization, stability testing, and quality control. You will play a key role in ensuring the quality and safety of our pharmaceutical pipeline, from early-stage development through to commercialization. This is an excellent opportunity to contribute to significant projects within a collaborative and scientifically driven environment in Bloemfontein .

Key Responsibilities

• Develop and validate analytical methods (e.g., HPLC, GC, UV-Vis, KF, dissolution) for the characterization and quality control of drug substances and drug products.
• Perform method transfer to QC laboratories and provide ongoing method support.
• Conduct forced degradation studies to elucidate degradation pathways and support stability indicating method development.
• Analyze raw materials, in-process samples, and finished products to ensure compliance with specifications.
• Troubleshoot analytical issues and implement corrective actions to ensure data integrity and timely results.
• Interpret complex analytical data and author detailed reports, protocols, and validation summaries.
• Contribute to regulatory submissions by providing well-documented analytical data and method descriptions.
• Stay abreast of new analytical technologies, regulatory guidelines (e.g., ICH), and industry best practices.
• Collaborate effectively with formulation development, process chemistry, quality assurance, and regulatory affairs teams.
• Maintain laboratory equipment and ensure compliance with GLP/cGMP standards.
• Mentor junior scientists and contribute to the overall scientific development of the analytical team.
• Ensure all analytical activities in Bloemfontein adhere to safety and environmental regulations.

Requirements

• Ph.D. or Master's degree in Analytical Chemistry, Pharmaceutical Sciences, or a related discipline.
• Minimum of 5 years of experience in pharmaceutical analytical development.
• Extensive hands-on experience with various analytical techniques, particularly HPLC, UPLC, GC, and spectroscopic methods.
• Proven experience in method validation according to ICH guidelines.
• Strong understanding of drug substance and drug product characterization.
• Knowledge of regulatory requirements (e.g., ICH, FDA, EMA, SAHPRA) related to analytical testing.
• Excellent data analysis, interpretation, and scientific writing skills.
• Strong problem-solving abilities and attention to detail.
• Ability to manage multiple projects and work effectively in a team-oriented environment.
• Familiarity with LIMS and electronic laboratory notebooks (ELN) is a plus.

Benefits

Our client offers a competitive salary and comprehensive benefits package, recognizing the expertise and contribution of our scientists. This includes excellent health coverage, life assurance, and a valuable retirement savings plan. We are committed to employee growth and provide opportunities for continuous learning, professional development courses, and attendance at key scientific conferences. This role is based in our modern laboratory facilities in Bloemfontein , providing a supportive and stimulating work environment conducive to scientific advancement. We believe in fostering a work-life balance for our employees.