Senior Analytical Development Scientist - Method Validation

Placements24; Upington; Hybrid; ZAR 900,000 - 1,500,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Home office stipend

Paid time off

Life insurance

401(k) plan

Job summary

Placements24 is seeking a Senior Analytical Development Scientist for a remote-first role within a cutting-edge R&D division. Lead method development and validation for pharmaceutical products, ensuring GMP/GLP, ICH compliance, and robust data integrity across global teams.

The ideal candidate holds a PhD or Master’s in Analytical/Pharmaceutical Chemistry with 5+ years in analytical development, expertise in HPLC/UPLC/GC and associated software, and strong communication skills to support

Qualifications

• Ph.D. or Master’s in Analytical Chemistry, Pharmaceutical Chemistry or related field.
• Minimum 5 years in analytical development in pharma/biotech.
• Hands-on method development and validation for small molecules and/or biologics.
• Proficient with HPLC/UPLC/GC/MS/spectroscopy instruments.
• Strong understanding of ICH guidelines for validation and stability testing.
• Excellent data analysis; familiarity with Empower/Chromeleon.
• Independent work style; strong communication in a dispersed team.
• Knowledge of impurity profiling; PAT is a plus.

Responsibilities

• Develop, optimize, and validate analytical methods for materials and products.
• Design analytical studies for formulation development, stability programs, and manufacturing issues.
• Operate and maintain instruments: HPLC/UPLC, GC, MS, spectroscopy, dissolution, FTIR.
• Ensure GMP/GLP and ICH compliance; write method validation protocols and reports.
• Analyze complex data, troubleshoot method performance; review regulatory submissions.
• Collaborate with formulation, process, QC, and regulatory teams in a remote setting.

Skills

Analytical chemistry

HPLC

UPLC

GC

MS

Spectroscopy

Impurity profiling

PAT

ICH guidelines

Data analysis

Regulatory writing

Education

PhD in Analytical Chemistry

Master’s in Analytical Chemistry

Tools

Empower

Chromeleon

Job description

About the Role

Our client is seeking a highly skilled Senior Analytical Development Scientist to join their fully remote, state-of-the-art research and development division. This position is critical for developing and validating robust analytical methods required for the characterization and quality control of pharmaceutical products throughout their lifecycle. You will leverage your expertise in analytical chemistry and instrumentation to support formulation development, stability studies, and manufacturing processes. This is a remote-first role, requiring strong self-management, excellent communication skills, and the ability to collaborate effectively with global teams. The ideal candidate will possess a deep understanding of analytical techniques such as HPLC, GC, MS, spectroscopy, and dissolution testing, along with a proven track record in method development and validation according to regulatory guidelines. You will play a key role in ensuring the quality and safety of our client's pharmaceutical pipeline from discovery to market.

Key Responsibilities

Develop, optimize, and validate analytical methods for raw materials, intermediates, and finished pharmaceutical products. Design and execute analytical studies to support formulation development, stability programs, and troubleshooting manufacturing issues. Utilize a range of analytical instrumentation, including HPLC, UPLC, GC, LC-MS, GC-MS, FTIR, UV-Vis, and dissolution apparatus. Ensure all analytical activities are conducted in compliance with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and ICH guidelines. Prepare detailed analytical method validation protocols and reports. Analyze and interpret complex analytical data, troubleshooting method performance issues as they arise. Write and review analytical sections of regulatory submission documents (e.g., IND, NDA, MAA). Collaborate closely with formulation scientists, process engineers, quality control, and regulatory affairs teams in a remote setting. Stay current with scientific literature, emerging analytical technologies, and regulatory expectations. Maintain accurate laboratory records and contribute to a culture of scientific rigor and data integrity.

Requirements

Ph.D. or Master's degree in Analytical Chemistry, Pharmaceutical Chemistry, or a closely related scientific discipline. Minimum of 5 years of experience in analytical development within the pharmaceutical or biotechnology industry. Extensive hands-on experience with method development and validation for small molecules and/or biologics. Proficiency in operating and maintaining advanced analytical instrumentation (HPLC, UPLC, GC, MS, spectroscopy). Strong understanding of ICH guidelines for method validation and stability testing. Excellent data analysis and interpretation skills, with experience in relevant software (e.g., Empower, Chromeleon). Demonstrated ability to work independently and as part of a geographically dispersed team, managing multiple projects. Strong written and verbal communication skills, with the ability to present technical information clearly. Experience with impurity profiling and identification is highly desirable. Knowledge of PAT (Process Analytical Technology) is a plus.

Benefits

Our client offers a highly competitive salary and a comprehensive benefits package tailored for a remote workforce. This includes robust health, dental, and vision insurance, a generous 401(k) retirement savings plan with company match, life insurance, and paid time off. A home office stipend is provided to ensure an optimal remote work setup. Opportunities for professional development, continued learning, and attending scientific conferences are readily available. This remote role, conceptually linked to Upington, Northern Cape , offers significant autonomy and the chance to contribute to the advancement of high-quality pharmaceutical products that impact global health.