Operator - Research & Development

JobItUs; Bharuch District; On-site; INR 6,00,000 - 10,00,000; Full time

Job summary

A leading pharmaceutical company in Gujarat, India, is seeking a process development specialist to design and execute organic synthesis for API production. The role involves preparing documentation for technology transfer, collaborating with teams for scale-up, and utilizing analytical data from various instruments. Candidates should have experience with impurity profiling and must adhere to safety protocols in the lab. This is an exciting opportunity in a dynamic and collaborative work environment.

Responsibilities

• Design and execute multi-step organic synthesis experiments for API synthesis.
• Prepare and document process development reports for scale-up.
• Utilize analytical data from instruments like HPLC and Mass Spectrometry.
• Identify and characterize impurities to ensure product quality.
• Work closely with cross-functional teams in a collaborative environment.
• Adhere to safety protocols and maintain laboratory equipment.

Job description

Key Responsibilities

• Process Development:

  • Design and execute multi-step organic synthesis experiments to develop new and innovative routes for API synthesis.
  • Conduct literature searches and patent reviews to identify non-infringing and commercially viable synthesis routes.
  • Optimize reaction parameters such as temperature, pressure, time, and solvent to improve yield, purity, and reduce costs.

• Technology Transfer:

  • Prepare and document process development reports and technology transfer documents (TTDs) for seamless scale-up.
  • Collaborate with pilot plant and manufacturing teams to successfully transfer developed processes.
  • Provide technical support and troubleshoot issues during scale-up and commercial production batches.

• Analytical and Data Management:

  • Utilize and interpret analytical data from instruments like HPLC, GC, NMR, Mass Spectrometry, and IR to monitor reactions and characterize products.
  • Ensure all experimental data and observations are meticulously recorded in a laboratory notebook, maintaining Good Laboratory Practices (GLP).
  • Compile stability data and other technical documents required for regulatory filings (e.g., Drug Master Files or DMFs).

• Impurity Profiling:

  • Identify, synthesize, and characterize impurities and degradation products to ensure product quality and regulatory compliance.
  • Conduct forced degradation studies to understand the stability profile of APIs.

• Collaboration & Communication:

  • Work closely with cross‑functional teams including Analytical R&D (AR&D), Quality Assurance (QA), Quality Control (QC), and Regulatory Affairs.
  • Communicate project progress, challenges, and results to the R&D Manager and other stakeholders.
  • Mentor junior team members and contribute to a positive and collaborative work environment.

• Safety & Compliance:

  • Adhere to all safety protocols and company policies, especially when handling hazardous or sensitive chemicals.
  • Maintain a clean and organized work area and ensure proper maintenance and calibration of laboratory equipment.
  • Stay updated on the latest regulatory guidelines and industry trends.