As an R&D Scientist in the API Development team, you will be responsible for independently planning and executing the synthesis of drug intermediates and active pharmaceutical ingredients (APIs). The role involves literature research, route scouting, cost analysis, troubleshooting, and working closely with cross-functional teams to support scale-up and commercialization of APIs.
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Key Responsibilities
1. Molecule Assessment & Route Design:
Perform detailed literature surveys and identify synthetic routes using tools like SciFinder, Reaxys, and patents.
Conduct route feasibility studies and perform cost calculations (RTDC).
Provide technical inputs to R&D leadership for project planning and decision-making.
2. Formulation Execution:
Plan and carry out formulation development of assigned products.
Optimize composition and process parameters, prepare trial batches, and evaluate key attributes.
Maintain focus on stability, efficacy, and scalability of formulations.
3. Project Management:
Execute and monitor multiple projects within stipulated timelines.
Troubleshoot synthetic or process issues proactively.
Ensure timely completion of assigned tasks.
4. Process Documentation & Compliance:
Generate specifications for raw materials, intermediates, and final APIs.
Prepare and review laboratory development reports and SOPs.
Maintain accurate lab notebooks and ensure GLP compliance.
5. Vendor & Lab Coordination:
Support vendor qualification processes by providing technical documents and test procedures.
Participate in lab validation and preparation of AMV (Analytical Method Validation) protocols.
6. Technical Support to Scale-Up:
Assist in the transfer of developed processes to pilot and commercial plant scale.
Troubleshoot issues during scale-up and ensure validation of processes in coordination with tech transfer teams.
7. Cross-functional Collaboration:
Coordinate with Analytical R&D, Regulatory Affairs, Quality Assurance, and Production teams.
Analyze reports from analytical departments and implement required changes in the synthesis plan.
8. Innovation & Continuous Improvement:
Continuously evaluate existing processes for improvement opportunities.
Drive innovations that reduce cost, time, and environmental impact.
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Key Skills & Competencies:
Strong knowledge of synthetic organic chemistry and reaction mechanisms
Proficiency in handling laboratory equipment and analytical instruments (HPLC, GC, NMR, etc.)
Sound documentation and regulatory understanding
Good communication and team collaboration skills
Problem-solving and troubleshooting mindset
These activities are supported with a strong infrastructure such as 5 manufacturing plants, 21 branch offices – cum – distribution centers, more than 300 strong marketing force throughout the country meeting 50,000 doctors every month supported by a network of around 1000 stockiest–cum–distributors. The company is putting a lot of thrust towards R & D efforts and has successfully launched few technologies, the first time in the country through its own government approved R&D centers. --- Group of Companies also have received three Export awards from the government and over a dozen awards from various organizations in recognition of its achievements.