Leading Pharmaceutical Formulation Process Optimization Specialist

3 days ago

Nagpur, Maharashtra, India beBeeProcessDevelopment Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

Job Title: Process Formulation Development Lead

Key Responsibilities:
  • Design, optimize and implement innovative manufacturing processes with technical enhancements for regulated markets worldwide.
  • Conduct in-depth evaluations of manufacturing processes using Design of Experimentation (DoE) and Quality by Design (QbD) methodologies to define design space, control strategy, critical/key parameters, and identify process risks.
  • Assess and select suitable manufacturing sites based on formulation and process complexity/feasibility criteria.
  • Lead technology transfer functions with excellent project management skills to ensure seamless scale-up of new products and effective launches within stipulated timeframes.
  • Develop and maintain procedures for smooth product transfers between development and manufacturing, ensuring robust scale-up, accurate filings, and successful launches.
  • Serve as Subject Matter Expert (SME) for pharmaceutical processes and technologies, providing guidance in tech transfer, troubleshooting, and investigations to ensure optimal performance and timely supply.
  • Establish and enforce standards for formulation technology transfer and be the primary point of contact for formulation technology transfer activities.
  • Initiate, drive, and facilitate capacity enhancement, cost reduction, and time cycle reduction projects to improve overall efficiency.
  • Review and approve departmental Standard Operating Procedures (SOPs) to ensure compliance with Current Good Manufacturing Practices (cGMP) and Control Quality Assurance (CQA) guidelines, technical changes, change control, deviations, and relevant documents.
Required Skills and Qualifications:
  • Expertise in formulation development of various dosage forms with strong knowledge of process optimization techniques.
  • Hands-on experience in technology transfer and scale-up operations.
  • Strong understanding of regulatory guidelines, including US FDA, EMA, and WHO regulations.
  • Excellent documentation, communication, and analytical skills.
  • Ability to work effectively in a fast-paced, dynamic environment.
  • Project management and cross-functional coordination expertise.

Summary: This role requires a seasoned professional with expertise in formulation development, technology transfer, and process optimization. The ideal candidate will have a strong understanding of regulatory guidelines and excellent documentation, communication, and analytical skills.

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