Analytical Development Scientist - Small Molecules

Placements24; East London; On-site; ZAR 1,000,000 - 1,300,000; Full time

Benefits offered by this job

Health insurance

Retirement plan

Performance-based bonuses

Job summary

Placements24 in East London, Eastern Cape, seeks an Analytical Development Scientist to develop, validate, and transfer analytical methods for small molecule therapeutics. You will work with QC, formulation development, and process chemistry to ensure product integrity throughout development and into commercial production.

The role requires 4+ years in analytical development, strong HPLC expertise, and knowledge of regulatory expectations (ICH, GMP).

Qualifications

• Master's or PhD in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences, or related field.
• Minimum of 4 years of experience in analytical development within the pharmaceutical industry, focusing on small molecules.
• Extensive hands-on experience with HPLC (method development, validation, troubleshooting).
• Proficiency with GC, LC-MS, GC-MS, FTIR, UV-Vis, dissolution, and Karl Fischer titration.

Responsibilities

• Develop, optimize, and validate analytical methods for small molecule drug substances and finished products using HPLC, GC, UV-Vis, KF, and dissolution testing.
• Characterize drug substances and impurities, elucidating structures where necessary.
• Develop stability-indicating methods to assess product degradation and shelf-life.
• Perform method transfer to QC laboratories and provide training and support.
• Troubleshoot analytical issues encountered during method development, validation, and routine testing.
• Author and review method validation protocols, reports, and analytical sections of regulatory submissions (e.g., IND, NDA, ANDA).
• Ensure all analytical activities comply with GMP, ICH guidelines, and regulatory requirements.

Skills

Analytical Chemistry

HPLC method development

Method validation

Troubleshooting

Documentation

Cross-functional collaboration

Regulatory awareness

Education

Master's or PhD in Analytical Chemistry

Tools

Empower

ChemStation

LIMS

GC-MS

LC-MS

FTIR

Job description

About the Role

Our client, a leading pharmaceutical company recognized for its innovation in developing and manufacturing high-quality small molecule therapeutics, is seeking a skilled Analytical Development Scientist to join their dedicated team. This on-site role, based in our state-of-the-art facility in East London, Eastern Cape, is critical for developing and validating analytical methods used to assess the quality, purity, and stability of drug substances and finished products. You will work closely with formulation development, process chemistry, and quality control departments to ensure product integrity throughout the development lifecycle and into commercial production. The ideal candidate possesses a strong foundation in analytical chemistry, extensive experience with various analytical techniques, and a thorough understanding of regulatory requirements. We are looking for a detail-oriented scientist committed to scientific rigor and continuous improvement.

Key Responsibilities

• Develop, optimize, and validate analytical methods for small molecule drug substances and finished products using techniques such as HPLC, GC, UV-Vis, KF, and dissolution testing.
• Characterize drug substances and impurities, elucidating structures where necessary.
• Develop stability-indicating methods to assess product degradation and shelf-life.
• Perform method transfer to Quality Control (QC) laboratories and provide necessary training and support.
• Troubleshoot analytical issues encountered during method development, validation, and routine testing.
• Author and review method validation protocols, reports, and analytical sections of regulatory submissions (e.g., IND, NDA, ANDA).
• Ensure all analytical activities are conducted in compliance with GMP, ICH guidelines, and other relevant regulatory requirements.
• Stay current with advancements in analytical technologies and regulatory expectations.
• Collaborate effectively with cross-functional teams, including formulation, process development, and quality assurance.
• Maintain accurate and complete laboratory records and documentation.

Requirements

• Master's or PhD degree in Analytical Chemistry, Organic Chemistry, Pharmaceutical Sciences, or a related field.
• Minimum of 4 years of experience in analytical development within the pharmaceutical industry, focusing on small molecules.
• Extensive hands-on experience with HPLC (including method development, validation, and troubleshooting) is essential.
• Proficiency with other analytical techniques such as GC, LC-MS, GC-MS, FTIR, UV-Vis, dissolution apparatus, and Karl Fischer titration.
• Strong understanding of ICH guidelines (Q2, Q3A/B/C/D, Q7) and regulatory submission requirements.
• Excellent written and verbal communication skills, with the ability to author technical documents and reports.
• Strong problem-solving skills and meticulous attention to detail.
• Ability to work independently and collaboratively in a laboratory environment.
• Experience with laboratory information management systems (LIMS) is a plus.
• Proficiency in relevant software (e.g., Empower, ChemStation, LIMS).

Benefits

• Our client offers a competitive salary and a comprehensive benefits package, including health insurance, a retirement plan, and performance-related bonuses.
• This role provides an excellent opportunity for career growth and professional development within a leading pharmaceutical organization.
• You will work with state-of-the-art analytical instrumentation and contribute to the development of vital medicines.
• The on-site position fosters strong team collaboration and direct impact on product quality.
• Additional benefits include opportunities for attending scientific conferences, access to advanced training programs, and study leave.