Senior Analytical Development Scientist – GMP/ICH Expert

Placements24; Rustenburg; Hybrid; ZAR 1,200,000 - 1,800,000; Full time

Benefits offered by this job

Health insurance

Professional development

Access to lab equipment

Retirement plan

Leadership opportunities

Collaborative work environment

Job summary

Placements24 in Rustenburg, North West, seeks a Principal Analytical Development Scientist to lead the development, validation and regulatory compliant analytical methods for APIs and finished products.

You will oversee the characterization using HPLC, GC, MS, FTIR, and dissolution, design stability studies per ICH, and mentor a team of scientists to ensure data integrity and quality.

Qualifications

• PhD or Master in Analytical Chemistry, Pharmaceutical Sciences or related field.
• 8+ years of hands-on analytical method development and validation in pharma.
• Extensive knowledge of cGMP and ICH guidelines for analytical development.
• Proficiency with analytical instrumentation: HPLC/UPLC, GC, MS, FTIR, dissolution.
• Experience leading analytical development projects and cross-functional teams.

Responsibilities

• Lead the development, optimization, and validation of analytical methods for materials, in-process samples, and finished products.
• Characterize drug substances and products using multiple techniques (HPLC, GC, MS, FTIR, dissolution).
• Design and execute stability studies per ICH guidelines and regulatory requirements.
• Troubleshoot analytical issues during method development, validation, and routine testing.
• Provide scientific guidance to a team of analytical scientists and technicians.
• Write and review validation protocols, reports, and regulatory submission documents.
• Collaborate with formulation development, manufacturing, and QA to support product development.
• Stay current with literature, industry trends and regulatory expectations for analytical development.

Skills

Analytical chemistry

Method development

Method validation

HPLC/UPLC

GC

MS

cGMP/ICH

Team leadership

Technical writing

Education

PhD in Analytical Chemistry

Master's in Pharmaceutical Sciences

Tools

HPLC/UPLC

GC

Mass Spectrometry

FTIR

Dissolution testing

XRPD

DSC

TGA

Job description

Placements24 in Rustenburg, North West, seeks a Principal Analytical Development Scientist to lead the development, validation and regulatory compliant analytical methods for APIs and finished products.

You will oversee the characterization using HPLC, GC, MS, FTIR, and dissolution, design stability studies per ICH, and mentor a team of scientists to ensure data integrity and quality.