API Chemical Research and Development Scientist, API Analytical Development Scientist

Job Description for API Chemical Research and Development Scientist

We are seeking a skilled and motivated Mid-Level Research Scientist to join our Active Pharmaceutical Ingredient (API) Process Research & Development this role you will design optimize and scale up safe cost-effective and robust chemical processes for drug substances. You will bridge the gap between discovery chemistry and pilot-plant scale production ensuring all processes align with current regulatory and safety standards.

Key Responsibilities

• Route Scouting: Design and execute multi-step organic synthesis routes for generic APIs.

• Process Optimization: Optimize existing reaction parameters (yield purity throughput and cost) using Quality by Design (QbD) principles.

• Scale-Up Support: Execute lab-scale validation batches and collaborate with engineering teams for tech transfer to the pilot plant.

• Analytical Characterization: Interpret complex analytical data from HPLC GC NMR LC-MS and Karl Fischer to monitor reactions and confirm structures.

• Documentation: Maintain accurate laboratory notebooks and draft tech transfer reports (TTRs) and standard operating procedures (SOPs).

• Safety & Compliance: Ensure all lab activities comply with cGMP guidelines data integrity standards and EHS safety protocols.

Qualifications & Skills

• Education: . or Ph.D. in Organic Chemistry Medicinal Chemistry or a closely related field.

• Experience: 4 to 7 years of industrial experience in API Process R&D (for .) or 0 to 3 years (for Ph.D.).

• Technical Skills: Strong proficiency in retrosynthetic analysis purification techniques (crystallization distillation chromatography).

• Software: Familiarity with SciFinder Reaxys Chemdraw.

• Core Competencies: Excellent problem-solving skills strong teamwork and clear technical communication skills.

•