Senior Analytical Scientist - Method Validation

Placements24; Paarl; Hybrid; ZAR 900,000 - 1,300,000; Full time

Benefits offered by this job

Medical aid

Provident fund

Life insurance

Performance bonus

Job summary

Placements24 seeks a Senior Analytical Scientist to lead method validation for a pharmaceutical research company in Paarl, Western Cape. The hybrid role combines strategic planning off-site with essential on-site lab work, driving regulatory-compliant method development and transfer.

Candidates should hold an MSc/PhD in Analytical Chemistry with 5+ years’ pharma experience, hands-on with HPLC/GC/UV-Vis/dissolution, and strong data integrity skills to support QA, R&D, and formulation teams.

Qualifications

• MSc or PhD in Analytical Chemistry or related field.
• 5+ years in analytical method development and validation in the pharmaceutical industry.
• Knowledge of ICH guidelines, USP/EP monographs, and regulatory submissions.
• Hands-on with HPLC, GC, UV-Vis, dissolution systems.
• Strong data integrity and statistical analysis for validation.
• Excellent written and verbal communication; strong reporting abilities.

Responsibilities

• Develop and validate analytical methods per ICH and regulatory standards.
• Execute method validation protocols: specificity, linearity, accuracy, precision, range, LOD/LOQ.
• Transfer validated methods to QC labs and provide training.
• Troubleshoot analytical issues and investigate OOS results.
• Prepare validation reports, protocols, and regulatory documents.
• Collaborate with formulation development, R&D, and QA departments.
• Stay updated on regulatory expectations and best practices for analytical validation.
• Contribute to continual improvement of analytical processes and lab operations.

Skills

Analytical method development

ICH guidelines

Data integrity

Report writing

Project management

Detail-oriented

Communication skills

Education

MSc/PhD in Analytical Chemistry

Tools

HPLC

GC

UV-Vis

Dissolution apparatus

Job description

About the Role

Our client, a dynamic pharmaceutical research company, is seeking a highly skilled Senior Analytical Scientist specializing in Method Validation to join their quality control and development team in **Paarl, Western Cape**. This role is critical for ensuring the accuracy, reliability, and robustness of analytical methods used in drug development and manufacturing. The ideal candidate will have extensive experience in method development, validation, and transfer, working with a variety of analytical techniques. You will play a key part in regulatory compliance and quality assurance, contributing to the successful delivery of high-quality pharmaceutical products. This hybrid role offers flexibility, balancing remote strategic planning with essential on-site laboratory work.

Key Responsibilities

• Develop and validate analytical methods (e.g., HPLC, GC, dissolution, KF) in accordance with ICH guidelines and regulatory requirements.
• Execute method validation protocols, including specificity, linearity, accuracy, precision, range, LOD, and LOQ studies.
• Transfer validated methods to QC laboratories and provide necessary training.
• Troubleshoot analytical issues and investigate out-of-specification (OOS) results.
• Prepare comprehensive validation reports, protocols, and other regulatory documentation.
• Collaborate with formulation development, R&D, and quality assurance departments.
• Stay updated on current regulatory expectations and industry best practices for analytical validation.
• Contribute to the continuous improvement of analytical processes and laboratory operations.

Requirements

• MSc or PhD in Analytical Chemistry, Pharmaceutical Sciences, or a related discipline.
• Minimum of 5 years of experience in analytical method development and validation within the pharmaceutical industry.
• In-depth knowledge of ICH guidelines, USP/EP monographs, and regulatory submission requirements.
• Hands‑on experience with HPLC, GC, UV-Vis, dissolution apparatus, and other relevant analytical instrumentation.
• Strong understanding of data integrity principles and statistical analysis for validation studies.
• Excellent written and verbal communication skills, with strong report‑writing abilities.
• Ability to manage multiple projects, prioritize tasks, and meet deadlines.
• Detail‑oriented with strong problem‑solving skills.

Benefits

Our client offers a competitive salary package, complemented by a performance bonus and a comprehensive benefits program including medical aid, a provident fund, and life insurance. We support continuous professional development and offer opportunities for career advancement. This hybrid role, based in **Paarl, Western Cape**, provides a structured yet flexible work environment, contributing to a culture of quality and scientific rigor.