Senior Analytical Development Scientist - Chromatography

Placements24; Benoni; Vor Ort; ZAR 900.000 - 1.300.000; Vollzeit

Benefits dieser Stelle

Health insurance

Retirement savings plans

Annual bonuses

Relocation assistance

Zusammenfassung

Placements24 in Benoni, Gauteng, seeks a Senior Analytical Development Scientist with chromatography expertise. You will develop, validate, and transfer robust analytical methods (HPLC, UPLC, GC) for APIs and drug products, ensuring purity, potency, and stability.

The role involves hands-on method development, regulatory alignment with ICH guidelines, collaboration with QC and regulatory affairs, mentoring junior scientists, and maintaining GLP lab practices at our Benoni facility.

Qualifikationen

• PhD or MSc in Analytical Chemistry or related field.
• 5–7 years of analytical method development experience in pharmaceutical industry.
• Strong knowledge of HPLC/UPLC and GC with instrument maintenance and troubleshooting.

Aufgaben

• Develop and optimize chromatographic methods for APIs and drug products.
• Validate analytical methods according to ICH guidelines and regulatory requirements.
• Investigate and resolve complex analytical challenges related to method performance and sample matrices.
• Perform impurity profiling, stability testing, and forced degradation studies.
• Characterize raw materials, intermediates, and finished products using advanced analytical techniques.
• Transfer validated methods to Quality Control and external testing sites.
• Prepare development and validation documentation including reports and protocols.
• Stay updated with regulatory guidelines and industry best practices in analytical development.
• Mentor junior analytical scientists and provide technical guidance.
• Maintain GLP-compliant laboratory operations and equipment in Benoni.

Kenntnisse

Chromatography

HPLC/UPLC/GC

Analytical Chemistry

Method Validation

ICH Guidelines

Data Analysis

LIMS

Team mentoring

Ausbildung

PhD in Analytical Chemistry

MSc in Analytical Chemistry

Tools

Agilent instruments

Waters instruments

MS detectors

Jobbeschreibung

About the Role

Our client, a leading pharmaceutical development company located in Benoni, Gauteng , is seeking a highly experienced Senior Analytical Development Scientist with a specialization in chromatography. This critical role focuses on the development, validation, and transfer of robust analytical methods for the characterization and quality control of pharmaceutical products. You will be instrumental in establishing state‑of‑the‑art chromatographic methods (HPLC, UPLC, GC) to ensure the purity, potency, and stability of drug substances and finished products. The position is based at our advanced research and development facility in Benoni , offering a dynamic, hands‑on laboratory environment. The ideal candidate will possess a deep understanding of analytical chemistry principles, significant practical experience with various chromatographic techniques, and a strong track record of method development and validation within the pharmaceutical industry. You will collaborate closely with formulation scientists, quality control teams, and regulatory affairs personnel to bring safe and effective medicines to market.

Key Responsibilities

• Develop and optimize chromatographic methods (HPLC, UPLC, GC) for the analysis of APIs and drug products.


• Validate analytical methods according to ICH guidelines and regulatory requirements.


• Investigate and resolve complex analytical challenges related to method performance and sample matrices.


• Perform impurity profiling, stability testing, and forced degradation studies.


• Characterize raw materials, intermediates, and finished products using advanced analytical techniques.


• Transfer validated analytical methods to the Quality Control department and external testing sites.


• Prepare comprehensive documentation, including development reports, validation protocols, and validation reports.


• Stay current with regulatory guidelines and industry best practices in analytical development.


• Mentor junior analytical scientists and provide technical expertise.


• Maintain laboratory equipment and ensure adherence to safety and GLP standards in Benoni .

Requirements

• Ph.D. or Master's degree in Analytical Chemistry, Pharmaceutical Sciences, or a related field.


• A minimum of 5-7 years of experience in analytical method development within the pharmaceutical industry.


• Extensive hands‑on experience with various HPLC and UPLC systems (e.g., Agilent, Waters) and detectors (UV, DAD, FL, MS).


• Proven experience with GC and relevant detectors (FID, TCD, MS).


• Strong understanding of method validation principles and ICH guidelines.


• Proficiency in data analysis software and LIMS systems.


• Excellent understanding of drug substance and drug product quality attributes.


• Strong problem‑solving skills and a meticulous attention to detail.


• Excellent written and verbal communication skills, with the ability to present complex technical information effectively.


• Ability to work independently and collaboratively within a fast‑paced R&D environment in Benoni, Gauteng .

Benefits

• Our client offers a highly competitive salary, commensurate with experience, and an attractive benefits package including health, dental, and vision insurance, retirement savings plans, and annual bonuses.


• Relocation assistance may be available for highly qualified candidates.

The role provides significant opportunities for professional growth and development within a leading pharmaceutical company. Employees have access to state‑of‑the‑art analytical instrumentation and a collaborative work environment in Benoni . We are committed to fostering a culture of scientific excellence and innovation.