Senior Analytical Development Scientist - Method Validation

Placements24; Randburg; Hybrid; ZAR 1,200,000 - 1,700,000; Full time

Benefits offered by this job

Competitive salary

Health insurance

Retirement plan

Paid time off

Hybrid work model

Professional development

Cutting-edge equipment

Career progression

Job summary

Placements24 seeks a Senior Analytical Development Scientist in Randburg to lead method development, validation, and transfer across drug substances and products. You will work in a hybrid setup with cross-functional teams to deliver compliant methods supporting lifecycle analytics.

You will apply HPLC/UPLC, GC, dissolution, and spectroscopy, ensure GLP/cGMP compliance, and mentor junior scientists while contributing to regulatory submissions and data integrity.

Qualifications

• PhD or Master’s degree in Analytical Chemistry, Pharmaceutical Sciences, or related field.
• 5+ years of experience in analytical method development and validation in pharma.
• Hands-on with HPLC/UPLC, GC, dissolution, spectroscopy and related detection methods.
• Solid grasp of ICH Q2(R1) guidelines and GMP/GLP principles.
• Proven ability to design, execute, and interpret method validation studies.

Responsibilities

• Develop, optimize, and transfer analytical methods for raw materials to finished products.
• Execute method validation studies per ICH guidelines and regulatory requirements.
• Troubleshoot methods and instrumentation; identify root causes and implement fixes.
• Characterize drug substances/products, including impurity profiling and stability studies.
• Collaborate with cross-functional teams to define analytical requirements.
• Ensure compliance with cGMP/GLP; maintain thorough lab records.
• Provide guidance to junior scientists and support regulatory submissions.

Skills

Analytical thinking

Problem solving

Effective communication

Education

PhD or Master's in Analytical Chemistry / Pharmaceutical Sciences

Tools

HPLC

UPLC

GC

Dissolution testing

Spectroscopy

Job description

About the Role

Our client, a prominent pharmaceutical innovator, is seeking a highly skilled Senior Analytical Development Scientist with expertise in method validation to join their research and development team in Randburg . This hybrid role is pivotal in developing, optimizing, and validating robust analytical methods essential for characterizing drug substances and drug products throughout their lifecycle. You will work with state-of-the-art analytical technologies and collaborate closely with formulation, process development, and quality control teams. The position demands a strong scientific background, meticulous attention to detail, and a proven track record in analytical method development and validation within a regulated pharmaceutical environment. Contribute to the quality and success of groundbreaking pharmaceutical products.

Key Responsibilities

• Develop, optimize, and transfer analytical methods (e.g., HPLC, UPLC, GC, dissolution, spectroscopy) for raw materials, intermediates, and finished products.
• Execute method validation studies according to ICH guidelines and regulatory requirements, preparing comprehensive validation protocols and reports.
• Troubleshoot analytical methods and instrumentation, identifying root causes of issues and implementing effective solutions.
• Characterize drug substances and drug products, including impurity profiling, stability studies, and release testing support.
• Collaborate with cross-functional teams to define analytical requirements and support product development milestones.
• Ensure all analytical development activities are performed in compliance with cGMP and Good Laboratory Practices (GLP).
• Maintain accurate and detailed laboratory records and documentation.
• Stay abreast of the latest advancements in analytical techniques and instrumentation.
• Provide technical guidance and mentorship to junior scientists.
• Participate in regulatory submissions by providing necessary analytical data and reports.

Requirements

• PhD or Master's degree in Analytical Chemistry, Pharmaceutical Sciences, or a related discipline.
• Minimum of 5 years of experience in analytical method development and validation within the pharmaceutical industry.
• Extensive hands-on experience with various analytical techniques, particularly HPLC/UPLC and relevant detection methods.
• Thorough understanding of ICH guidelines for method validation (Q2(R1)) and general GMP/GLP principles.
• Proven ability to design and execute method validation studies and interpret results.
• Experience with stability testing programs and impurity characterization.
• Strong problem-solving skills and meticulous attention to detail.
• Excellent written and verbal communication skills, with the ability to document scientific findings clearly.
• Ability to work effectively in a hybrid team environment, contributing from both the laboratory in Randburg and remotely.
• Proficiency in data analysis software and statistical tools.

Benefits

• Competitive salary and potential for annual bonuses.
• Comprehensive health insurance coverage.
• Retirement fund with employer contribution.
• Generous paid time off and holiday observance.
• Hybrid work model offering flexibility and work-life balance.
• Opportunities for advanced training and professional development.
• Access to cutting-edge analytical equipment and a collaborative R&D environment.
• Career progression within a leading pharmaceutical organization.
• Exposure to innovative drug development projects.
• Contribute to ensuring the quality and safety of pharmaceutical products.