M. GOPAL

Syngene International Ltd., based in Bangalore, is a leading contract research, development, and manufacturing organization (CRDMO) that offers integrated scientific services spanning early discovery to commercial supply.

syngeneintl.com

Key Responsibilities:

• Business Development Support: Engaging in activities such as costing, evaluating Requests for Proposals (RFPs), developing pricing and costing models, and identifying suitable raw material sources.
• Client Communication: Participating in conference calls and providing weekly written updates to clients, including research data management.
• Research Activities: Conducting literature surveys, patent searches, and route scouting for assigned projects.
• Information Access: Utilizing search engines like MDL Crossfire, Discovery Gate, and scientific journals such as ACS Publications, ScienceDirect, and Wiley Science.
• Process Safety and Scale-Up: Screening process safety and scaling up to kilo-level (cGMP/cGLP) for clinical, non-clinical, and commercial manufacturing of small molecules.
• Impurity Management: Identifying and characterizing impurities by performing negative experiments following protocols and ICH guidelines.
• Compliance: Adhering to Standard Operating Procedures (SOPs), health and safety policies, and maintaining good documentation practices in line with cGMP/cGLP guidelines.
• Team Leadership: Leading a team of four scientists, providing training, education, and guidance in scientific and technical skills.
• Cross-Functional Coordination: Collaborating with cross-functional teams (CFT) for tasks such as raw material procurement, analytical method validation, process validation, Batch Manufacturing Record (BMR) preparation, quality control/quality assurance approvals, packing, and shipment.
• Technology Transfer: Working with process engineers and plant operators to ensure successful technology transfer from lab to pilot plant and troubleshooting scale-up processes.
• Audit Participation: Actively participating in cGMP audits conducted by multinational clients from the USA and Germany.
• Process Optimization: Conducting technical feasibility studies, optimizing processes for commercialization, and developing new products.
• Analytical Expertise: Possessing strong skills in interpreting analytical data, including HPLC, GC, 1H & 13C NMR, LC-MS, and GC-MS.
• Documentation: Managing documentation such as logbooks, calibration records, and temperature and humidity records.
• Software Proficiency: Utilizing software tools like Chemsketch, Chembiodraw, ISIS Draw, and handling Enterprise Resource Planning (ERP) systems, including Oracle applications and SharePoint server.

Company Overview: Formerly Nicholas Piramal India Ltd. R&D Centre, Chennai Key Responsibilities: Research & Development Quality & Compliance Collaboration & Leadership

Piramal Healthcare Limited (formerly Nicholas Piramal India Ltd.) is a leading pharmaceutical research and development center focused on synthetic chemistry, process development, and quality assurance.

• Lab synthesis, characterization, and process development for assigned products.
• Conducting scale-up trials, raw material costing, and implementation at the plant level.
• Optimizing multi-step synthesis processes for projects with Merck, GSK, and Sanofi.
• Strong analytical data interpretation (HPLC, GC, NMR, LC-MS, GC-MS).
• Preparing Batch Manufacturing Records (BMR) and process development reports.
• Implementing quality assurance programs to meet company standards.
• Reducing failures at the customer’s end by improving quality control during production.
• Coordinating with the Analytical Team to enhance product quality and process efficiency.
• Sourcing chemical suppliers for raw materials.
• Leading and guiding a team in synthetic lab operations.
• Attending conference calls and reporting weekly updates on project progress.

• Company Overview: R&D centre Chennai
• Carrying out literature search for the assigned new products
• Lab synthesis and characterization of the product
• Active team member
• Process development for the assigned product, Scale up trials and implementation in plant level
• Interacting with Analytical Team to improve product quality and process development
• R&D centre Chennai
• Optimized process for the production of Ipriflavone- Osterphorosis drug
• Developed process for the Multi step synthesis for antibiotic and implemented in the plant
• Involved in various product and process patents

• Carrying out literature search for the assigned new products
• Lab synthesis and isolation of the products
• Active team leader and handled 5 members in the team
• Process development of the assigned product and scale up batches in Kg plant
• Trouble shooting and plant support
• Optimized process for the production of synthetic compounds
• Implemented in the plant scale