Principal Analytical Development Scientist

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

About the Role

Our client, a distinguished name in the pharmaceutical landscape, is seeking a highly experienced Principal Analytical Development Scientist to join their innovative team in Rustenburg, North West . This senior role is central to the development and validation of robust analytical methods essential for the characterization, quality control, and stability testing of pharmaceutical products. The successful candidate will play a crucial role in ensuring product quality and regulatory compliance throughout the product lifecycle. This position requires a deep expertise in analytical chemistry, method development, and validation, within the specific context of pharmaceutical manufacturing and research. You will lead complex analytical challenges and contribute significantly to the scientific integrity of our client's product portfolio in Rustenburg .

Key Responsibilities

• Lead the development, optimization, and validation of analytical methods for raw materials, in-process samples, and finished pharmaceutical products.
• Oversee the characterization of drug substances and drug products using a range of analytical techniques (e.g., HPLC, GC, MS, KF, UV-Vis, dissolution).
• Design and execute stability studies according to ICH guidelines and regulatory requirements.
• Troubleshoot and resolve complex analytical issues encountered during method development, validation, and routine testing.
• Provide scientific and technical guidance to a team of analytical scientists and technicians.
• Write and review comprehensive validation protocols, reports, and analytical method documentation for regulatory submissions.
• Collaborate with formulation development, manufacturing, and quality assurance departments to support product development and commercialization.
• Stay current with scientific literature, industry trends, and regulatory expectations related to analytical development.
• Ensure compliance with Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP) in all analytical activities conducted in Rustenburg .

Requirements

• Ph.D. or Master's degree in Analytical Chemistry, Pharmaceutical Sciences, or a related discipline.
• A minimum of 8 years of hands-on experience in analytical method development and validation within the pharmaceutical industry.
• Extensive knowledge of cGMP regulations and ICH guidelines relevant to analytical development.
• Proficiency with various analytical instrumentation, including HPLC/UPLC, GC, Mass Spectrometry (LC-MS, GC-MS), FTIR, and dissolution apparatus.
• Demonstrated experience in leading analytical development projects and troubleshooting complex analytical challenges.Strong understanding of pharmaceutical product development processes and quality control strategies.
• Excellent technical writing, communication, and interpersonal skills.
• Ability to work independently and lead cross-functional teams effectively.
• Experience with solid-state characterization techniques (e.g., XRPD, DSC, TGA) is a plus.
• Commitment to data integrity and scientific excellence in the North West region.

Benefits

• Annual salary of R, commensurate with experience.
• Comprehensive health, dental, and vision insurance coverage.
• Generous annual leave and paid public holidays.
• Opportunities for professional development and continuous training.
• Access to cutting-edge analytical laboratory equipment and resources.
• Retirement savings plan with company contributions.
• Potential for leadership growth within the organization.
• Supportive and collaborative work environment in Rustenburg .
• A chance to contribute to the development of innovative pharmaceutical products.