Principal Analytical Chemist - Pharmaceutical Analysis

Placements24

Sandton

On-site

ZAR 1,500,000 - 2,100,000

Full time

2 days ago
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Benefits offered by this job

Executive salary package
Medical, dental, and vision insurance
Retirement savings plan
Generous paid time off
Professional development and training

Job summary

Placements24 in Sandton, Gauteng, seeks a highly experienced Principal Analytical Chemist to lead analytical development for drug candidates and products. The role emphasizes method development, validation, and regulatory readiness, with mentorship of chemists and strategic direction for analytical sciences.

You will oversee transfer of methods, troubleshoot complex analyses, and ensure compliance with cGMP and ICH guidelines while driving adoption of advanced instrumentation and technologies.

Qualifications

  • Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or related field.
  • Minimum 10 years of progressive pharmaceutical analytical chemistry experience, with substantial method development/validation.
  • Extensive hands-on experience with HPLC/UPLC and LC-MS.
  • Deep knowledge of cGMP and ICH guidelines in analytical method development/validation.
  • Proven troubleshooting skills for analytical methods/instrumentation.
  • Demonstrated leadership and ability to mentor scientific staff.
  • Strong report writing and presentation skills.
  • Experience with OOS/OOT investigations and CAPA implementation.
  • Familiarity with QbD principles is a plus.

Responsibilities

  • Lead development, validation, and transfer of analytical methods for APIs and products.
  • Provide scientific leadership to a team of analytical chemists.
  • Troubleshoot complex analytical challenges and ensure timely resolutions.
  • Interpret data, write comprehensive reports, and contribute to regulatory submissions.
  • Ensure all activities comply with cGMP, ICH, and other regulations.
  • Evaluate and implement new analytical technologies and instrumentation.
  • Collaborate with R&D, manufacturing, QA, and regulatory affairs.
  • Contribute to risk assessments and impurity profiling.
  • Stay updated on trends in pharmaceutical analytical chemistry.

Skills

HPLC/UPLC
LC-MS
cGMP
ICH guidelines
Leadership
Report writing
Method development
CAPA
OOS/OOT investigations
QbD

Education

Ph.D. in Analytical Chemistry

Tools

HPLC
UPLC
LC-MS
GC
KF
Dissolution
Spectroscopy

Job description

About the Role

Our client, a renowned pharmaceutical company, is seeking a highly experienced and innovative Principal Analytical Chemist to lead their analytical development efforts in Sandton, Gauteng . This senior role is critical for the development, validation, and implementation of robust analytical methods to support the characterization and quality control of new drug candidates and commercial products. The Principal Analytical Chemist will be instrumental in setting strategic direction for analytical sciences, mentoring junior chemists, and ensuring compliance with stringent regulatory standards. The position offers a unique opportunity to work with cutting‑edge analytical instrumentation and contribute significantly to the pharmaceutical development pipeline. The ideal candidate possesses a Ph.D. in analytical chemistry, extensive experience in method development and validation for pharmaceuticals, and strong leadership capabilities. This is a premier opportunity to shape the future of pharmaceutical analysis in a dynamic and growth-oriented environment.

Key Responsibilities
  • Lead the development, validation, and transfer of analytical methods for raw materials, intermediates, and finished pharmaceutical products using techniques such as HPLC, UPLC, GC, MS, KF, dissolution, and spectroscopy.
  • Provide expert scientific guidance and technical leadership to a team of analytical chemists.
  • Troubleshoot complex analytical challenges and ensure timely resolution.
  • Interpret analytical data, prepare comprehensive reports, and contribute to regulatory submissions (e.g., IND, NDA).
  • Ensure all analytical activities comply with cGMP, ICH guidelines, and other relevant regulatory requirements.
  • Evaluate and implement new analytical technologies and instrumentation to enhance capabilities.
  • Collaborate effectively with R&D, manufacturing, quality assurance, and regulatory affairs departments.
  • Contribute to risk assessments and impurity profiling studies.
  • Stay abreast of current trends and advancements in pharmaceutical analytical chemistry.
Requirements
  • Ph.D. in Analytical Chemistry, Pharmaceutical Sciences, or a related field.
  • A minimum of 10 years of progressive experience in pharmaceutical analytical chemistry, with a substantial portion in method development and validation.
  • Extensive hands‑on experience with a wide range of analytical instrumentation, particularly HPLC/UPLC and LC-MS.
  • Deep understanding of pharmaceutical regulations (cGMP, ICH guidelines) and their application to analytical method development and validation.
  • Proven experience in troubleshooting analytical methods and instrumentation.
  • Demonstrated leadership skills with the ability to mentor and guide scientific staff.
  • Excellent written and verbal communication skills, with a strong track record of report writing and technical presentations.
  • Strong problem-solving, organizational, and project management abilities.
  • Experience with OOS/OOT investigations and CAPA implementation.
  • Familiarity with QbD (Quality by Design) principles in method development is a plus.
Benefits
  • Our client offers a highly competitive executive salary package, including significant base pay, performance bonuses, and potential long-term incentives.
  • Comprehensive medical, dental, and vision insurance are provided.
  • A generous retirement savings plan and extensive paid time off are included.
  • Opportunities for advanced professional development, such as attending international scientific symposia and specialized training programs, are readily available.
  • The company provides access to state‑art analytical laboratories and a stimulating, collaborative work environment in Sandton, Gauteng .
  • This role offers substantial opportunities for career advancement and leadership within a prestigious pharmaceutical organization.
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