Senior Pharmaceutical Development Scientist - API Process Chemistry

Placements24; United States; On-site; USD 72,000 - 120,000; Full time

Benefits offered by this job

Competitive salary with bonus

Medical, dental, retirement plans

State-of-the-art R&D facilities

Career advancement opportunities

Job summary

Placements24 in Randburg is seeking a Senior Pharmaceutical Development Scientist with expertise in API process chemistry to lead design, optimization, and scale-up of APIs at our advanced R&D center. You will oversee route scouting, reaction optimization, crystallization, and tech transfer with cross-functional teams, ensuring regulatory compliance and high-quality manufacturing.

This role offers a competitive salary, comprehensive benefits, and opportunities to drive innovation in API

Qualifications

• PhD or Master's in Organic Chemistry or Process Chemistry.
• Minimum 6 years' industry API process development experience.
• Proven expertise in synthetic organic chemistry and process optimization.
• Strong knowledge of ICH guidelines and QbD principles.
• Experience with HPLC, GC-MS, and NMR for process monitoring.
• Ability to lead projects and mentor junior scientists.

Responsibilities

• Design, develop, and optimize scalable API synthesis routes.
• Conduct lab experiments, process characterization, and impurity profiling.
• Lead process development activities including route scouting and crystallization.
• Collaborate with formulation, analytics, and manufacturing for tech transfer.
• Troubleshoot issues to improve yield, purity, and safety.
• Prepare process development reports and support regulatory filings.

Skills

API process development

Organic synthesis

Process optimization

Regulatory compliance (ICH, QbD)

Analytical techniques (HPLC, GC-MS, N"

Project leadership

Education

PhD in Organic Chemistry

Master's in Organic Chemistry

Process Chemistry degree

Tools

HPLC

GC-MS

NMR

Job description

About the Role

Our client is seeking a highly skilled Senior Pharmaceutical Development Scientist with expertise in API Process Chemistry to join their advanced research and development center in Randburg. This crucial role focuses on the design, optimization, and scale-up of synthetic routes for Active Pharmaceutical Ingredients (APIs). You will lead projects aimed at developing robust, cost-effective, and environmentally sound manufacturing processes that meet stringent regulatory and quality standards. This position offers a unique opportunity for a seasoned chemist to drive innovation in API development within a cutting-edge pharmaceutical organization committed to bringing novel therapies to patients worldwide.

Key Responsibilities

• Design, develop, and optimize synthetic routes for the scalable and efficient production of APIs.
• Conduct laboratory experiments, process characterization, and impurity profiling to ensure product quality and consistency.
• Lead process development activities, including route scouting, reaction optimization, and crystallization studies.
• Collaborate with formulation development, analytical development, and manufacturing teams to ensure seamless technology transfer.
• Troubleshoot process-related issues and implement solutions to enhance yield, purity, and safety.
• Prepare comprehensive process development reports and contribute to regulatory filings (e.g., CMC sections).

Requirements

• PhD or Master's degree in Organic Chemistry, Process Chemistry, or a related field.
• Minimum of 6 years of industry experience in API process development and scale-up within the pharmaceutical sector.
• Proven expertise in synthetic organic chemistry, reaction kinetics, and process optimization.
• Strong understanding of ICH guidelines, regulatory requirements, and quality by design (QbD) principles.
• Experience with analytical techniques for process monitoring and characterization (e.g., HPLC, GC-MS, NMR).
• Demonstrated ability to lead projects, mentor junior scientists, and work effectively in a multidisciplinary team environment.

Benefits

• A highly competitive salary and performance-based bonus structure.
• Comprehensive benefits package including medical, dental, and retirement savings plans.
• Significant opportunities for career advancement and leadership within R&D.
• Access to state-of-the-art research facilities and cutting-edge technology.
• A stimulating work environment that fosters innovation and scientific excellence.