Senior Analytical Development Scientist

Placements24; Willows (CA); Hybrid; USD 55,000 - 73,000; Full time

Benefits offered by this job

Comprehensive medical benefits

Retirement benefits

Professional development opportunities

Job summary

Placements24 is seeking a Senior Analytical Development Scientist for a hybrid role in the pharmaceutical R&D department. The candidate will lead development, validation, and transfer of analytical methods for raw materials, in-process samples, and finished products.

Requirements include a Ph.D. or Master’s in Analytical Chemistry or related field, 6+ years of pharmaceutical analytical development experience, and strong expertise with HPLC and GC within GMP/ICH frameworks.

Qualifications

• Ph.D. or Master’s in Analytical Chemistry, Pharmaceutical Sciences, or related field.
• Minimum 6 years of hands-on pharmaceutical analytical development experience.
• Extensive experience with HPLC and GC.
• Proven expertise in method development, validation, and transfer under GMP/ICH guidelines.
• Strong data analysis and reporting skills.
• Experience with LIMS and analytical software.

Responsibilities

• Develop, optimize, and validate analytical methods for drugs and products.
• Characterize substances and products (purity, potency, impurities).
• Troubleshoot analytical issues and ensure result reliability.
• Conduct stability studies per ICH guidelines and interpret data.
• Transfer methods to QC labs and support training.
• Prepare validation protocols and regulatory submission reports.
• Collaborate with cross-functional teams and stay updated on regulatory expectations.

Skills

HPLC

GC

Data analysis

LIMS

Analytical chemistry

Problem solving

Written communication

Verbal communication

Education

Ph.D. or Master’s in Analytical Chemistry or Pharmaceutical Sciences

Tools

GMP/ICH compliance

Job description

About the Role

Our client, a well-established pharmaceutical company, is seeking a highly experienced Senior Analytical Development Scientist to join their cutting-edge research and development department in Welkom, Free State. This critical role will focus on developing and validating robust analytical methods for raw materials, in-process samples, and finished pharmaceutical products. The successful candidate will play a key role in ensuring product quality and compliance throughout the product lifecycle, from early-stage development to commercialization. This hybrid role allows for a balance between essential laboratory work and remote data analysis and report writing, offering flexibility and efficiency. We are looking for a meticulous scientist with a strong background in pharmaceutical analysis and a drive for innovation.

Key Responsibilities

• Develop, optimize, and validate analytical methods (e.g., HPLC, GC, UV-Vis, KF, dissolution) for pharmaceutical compounds and products.
• Characterize drug substances and drug products, including purity, potency, and impurity profiling.
• Troubleshoot and resolve analytical method issues, ensuring the reliability and accuracy of results.
• Conduct stability studies according to ICH guidelines and interpret data to assess product shelf-life.
• Transfer analytical methods to Quality Control (QC) laboratories and provide necessary training and support.
• Prepare detailed analytical development reports, method validation protocols, and reports for regulatory submissions.
• Stay current with scientific advancements, regulatory expectations, and industry best practices in analytical chemistry.
• Collaborate with formulation scientists, process engineers, and quality assurance teams.
• Maintain laboratory equipment and ensure compliance with GLP (Good Laboratory Practice) standards.
• Mentor junior scientists and contribute to a culture of scientific excellence.

Requirements

• Ph.D. or Master's degree in Analytical Chemistry, Pharmaceutical Sciences, or a closely related discipline.
• Minimum of 6 years of hands-on experience in pharmaceutical analytical development.
• Extensive experience with various analytical techniques, particularly HPLC and GC, is mandatory.
• Proven expertise in method development, validation, and transfer under GMP and ICH guidelines.
• Strong understanding of pharmaceutical product development lifecycle and regulatory requirements.
• Excellent data analysis and interpretation skills.
• Proficiency in using analytical software and LIMS.
• Strong problem-solving abilities and attention to detail.
• Excellent written and verbal communication skills.
• Ability to work effectively in a hybrid team environment.
• Must be authorized to work in South Africa.

Benefits

• Competitive salary commensurate with experience.
• Comprehensive medical and retirement benefits.
• Performance-based bonuses.
• Opportunities for professional development and attending scientific conferences.
• Access to modern laboratory facilities and advanced instrumentation.
• Hybrid work arrangement offering flexibility.
• Supportive and collaborative work environment.
• Generous paid time off.