Process Development
4 days ago
Company: Laurus Labs Limited
Location: Atchutapuram , Visakhapatnam, Andhra Pradesh, India
Department: Process Development (PD) - API Generics & API Synthesis
Education: M.Sc. in Organic Chemistry / Analytical Chemistry
Experience: 1 - 8 Years
Job Type: Full-Time
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.
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