Process Development - API Generics & API Synthesis

Company:

Key Responsibilities

• Process Execution & Optimization:

  Execute experiments pertaining to various products at our facility, focusing on the development and optimization of robust, cost-effective, and scalable synthetic processes for generic APIs.

• Documentation & Data Management:

  Compile analytical results and prepare necessary documentation. Meticulously maintain Electronic Laboratory Notebooks (ELN), experimental data, and other project documents in accordance with GLP and regulatory guidelines.

• Inter-departmental Coordination:

  Coordinate effectively with the Analytical Development (AD), Quality Assurance (QA), Quality Control (QC), R&D, and Manufacturing teams for various process development activities and seamless technology transfer.

• Scale-Up & Tech Transfer:

  Collaborate closely with the Process Engineering and Production teams to facilitate the successful scale-up of processes from lab to pilot and commercial scale.

• Troubleshooting:

  Identify and troubleshoot process-related issues during development and initial production runs, providing recommendations for improvement.

• Analytical Coordination:

  Coordinate with the AD team for sample submission and results collection, ensuring timely analysis of in-process samples.

• Literature Search:

  Conduct extensive literature searches and collect relevant data for assigned projects to inform new process development or optimization efforts.

• EHS Compliance & Safety:

  Follow, implement, and ensure compliance with all applicable Environment, Health, and Safety (EHS) systems. Participate actively in EHS internal audits and authorize to stop any unsafe activities or environmental damage.

• Lab Maintenance & Tracking:

  Responsible for the maintenance and tracking of laboratory glassware, equipment, and general upkeep of the lab environment.

• Team Collaboration & Project Support:

  Execute projects effectively as a core member of the process development team, demonstrating a proactive learning attitude toward chemistry skills.

Desired Candidate Profile

• Educational Qualification:

  M.Sc. in Organic Chemistry / Analytical Chemistry is mandatory.

• Experience:

  1 to 8 years of relevant industrial experience in Process Development, API Synthesis / API Generics, CDMO (Contract Development and Manufacturing Organization ) or CRAMs (Contract Research and Manufacturing Services) within a recognized pharmaceutical company.

• Technical Skills:

  Deep understanding of organic reaction mechanisms, synthesis techniques, and process chemistry principles. Experience with GLP/GMP environments is highly beneficial.

• Soft Skills:

• Good communication skills, capable of effectively presenting data to cross-functional teams.
• Strong team player with a positive attitude and a passion for continuous learning and improvement.
• Quick learner with excellent analytical and problem-solving abilities.
• Demonstrates ownership and responsibility within the team framework, including coverage protocols for absent colleagues.