Chief Pharmaceutical Operations Specialist

2 days ago

Aligarh, Uttar Pradesh, India beBeeFormulation Full time ₹ 1,50,00,000 - ₹ 2,50,00,000
Key Role in Formulation Development and Research

As a seasoned professional with 12-16 years of experience in formulation development, you will play a vital part in designing and optimizing manufacturing processes for regulated markets.

Key Responsibilities:
  • Process Design and Optimization: Develop and implement technical improvements to manufacturing processes, ensuring timely delivery and regulatory compliance. Foster collaboration with cross-functional teams to drive process enhancements.
  • Manufacturing Process Evaluation: Utilize design of experiments (DoE) and quality by design (QbD) to define design space, control strategy, critical/key parameters, and identify process risks.
  • Site Selection: Screen manufacturing sites based on formulation and process complexity/feasibility, considering site capabilities and resources.
  • Technology Transfer: Lead technology transfer function with adequate project management skills to ensure successful scale-up of new products and effective launches.
  • Product Transfer: Define procedures for seamless product transfers between development and manufacturing, ensuring robust scale-up, accurate filings, and successful launches.
  • Technical Expertise: Serve as SME for pharmaceutical processes and technologies, providing guidance in tech transfer, troubleshooting, and investigations.
  • Standards and Compliance: Define and implement standards for formulation technology transfer and be the point contact for formulation technology transfer activities.
  • Capacity Enhancement: Initiate, drive, and facilitate capacity enhancement, cost reduction, and time cycle reduction projects, focusing on process efficiency and productivity.
  • Review and Approval: Review and approve departmental SOPs to ensure compliance with cGMP and CQA guidelines, promoting a culture of quality and excellence.

Essential Skills:

  • Expertise in formulation development of various dosage forms with strong knowledge of process optimization, leveraging expertise in statistical analysis and data-driven decision making.
  • Hands-on experience in technology transfer and scale-up, including validation and qualification of equipment and processes.
  • Strong understanding of regulatory guidelines such as USFDA, EMA, WHO, ensuring compliance with global regulations and industry standards.
  • Excellent documentation, communication, and analytical skills, facilitating effective collaboration and information exchange.
  • Ability to work in a fast-paced, dynamic environment, prioritizing tasks and managing multiple projects simultaneously.
  • Project management and cross-functional coordination, driving results-oriented projects and initiatives.

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