Senior Pharmaceutical Analytical Development Scientist

Placements24; Paarl; Hybrid; ZAR 900,000 - 1,200,000; Full time

Benefits offered by this job

Health insurance

Retirement provisions

Hybrid work arrangement

Job summary

Placements24 seeks a Senior Pharmaceutical Analytical Development Scientist in Paarl, Western Cape, to lead method development and validation for drug substances and products. You will support drug discovery and development programs, ensuring quality, purity, and potency of pharmaceutics.

The role requires a strong background in analytical chemistry, multiple techniques, and regulatory knowledge, with collaboration across R&D and QA. Hybrid work setup in a state-of-the-art facility.

Qualifications

• PhD or MSc in Analytical Chemistry or related field.
• 5+ years of analytical method development and validation experience in pharma.
• Expertise in HPLC/UPLC and Mass Spectrometry.
• Strong regulatory knowledge (ICH, FDA/EMA) and QMS.
• Proficient data analysis and problem-solving skills.
• Excellent written and verbal communication.

Responsibilities

• Develop, validate analytical methods for drug substances and products.
• Perform stability studies and analytical testing for preclinical and clinical stages.
• Characterize impurities and degradation products.
• Troubleshoot instrumentation and transfer methods to QC.
• Document development and validation reports per regulatory guidelines.
• Collaborate with formulation and quality teams.
• Stay updated with analytical science advancements.
• Ensure compliance with ICH, FDA, and EMA standards.

Skills

Analytical chemistry

Method development

Method validation

Mass spectrometry

HPLC/UPLC

Data analysis

Education

PhD in Analytical Chemistry

MSc in Analytical Chemistry

Tools

Empower

Chromeleon

LIMS

Job description

About the Role

Our client, a leading pharmaceutical research and development organization, is seeking a highly skilled Senior Pharmaceutical Analytical Development Scientist to join their innovative team. This exciting opportunity is based in Paarl, Western Cape , and focuses on the development and validation of analytical methods for drug substance and drug product characterization. You will play a crucial role in supporting drug discovery and development programs by ensuring the quality, purity, and potency of pharmaceutical compounds. The ideal candidate will have a strong background in analytical chemistry, method development, validation, and a thorough understanding of pharmaceutical quality standards. This position requires a meticulous approach, excellent problem-solving skills, and the ability to work effectively within a collaborative R&D environment. You will contribute to bringing novel therapies to market.

Key Responsibilities

• Develop, optimize, and validate analytical methods for the characterization of small molecules and biologics using techniques such as HPLC, UPLC, GC, MS, spectroscopy (UV-Vis, IR, NMR), and dissolution testing.
• Perform analytical testing to support pre-clinical and clinical development stages, including stability studies.
• Characterize drug substances and drug products, including impurity profiling and degradation studies.
• Troubleshoot analytical instrumentation and resolve method-related issues.
• Write detailed method development reports, validation protocols, and validation reports.
• Ensure compliance with regulatory guidelines (e.g., ICH, FDA, EMA) and company SOPs.
• Collaborate with formulation scientists, process chemists, and quality control teams to provide analytical support.
• Transfer validated analytical methods to Quality Control laboratories.
• Stay current with advancements in analytical science and instrumentation.

Requirements

• Ph.D. or Master's degree in Analytical Chemistry, Pharmaceutical Sciences, Organic Chemistry, or a related discipline.
• Minimum of 5 years of experience in analytical method development and validation within the pharmaceutical industry.
• Expertise in various analytical techniques, particularly HPLC/UPLC and Mass Spectrometry.
• Strong understanding of pharmaceutical quality systems and regulatory requirements.
• Proven experience with method validation according to ICH guidelines.
• Excellent data analysis, interpretation, and troubleshooting skills.
• Strong written and verbal communication skills, with the ability to document scientific findings clearly.
• Proficiency in using analytical software (e.g., Empower, Chromeleon) and laboratory information management systems (LIMS).
• Ability to work independently and manage multiple projects in a fast-paced environment.

Benefits

• Our client offers a competitive salary, comprehensive benefits including health insurance and retirement provisions, and opportunities for professional growth and development.
• This role is situated in the beautiful Paarl, Western Cape , with a hybrid work arrangement that supports both productivity and work-life balance.
• Employees have access to state-of-the-art analytical laboratories and the chance to contribute to significant advancements in pharmaceutical research.