Senior Pharmaceutical Process Engineer

1 day ago

Hubli, Karnataka, India beBeeFormulation Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Job Opportunity:

We are seeking an experienced Formulation Development Manager to lead our team in developing and optimizing manufacturing processes.

The ideal candidate will have a strong background in formulation development, with expertise in process optimization, technology transfer, and scale-up.

  • Key Responsibilities:
  • Develop and implement manufacturing processes for regulated markets within allotted timelines.
  • Evaluate manufacturing processes using design of experiments (DoE) and quality by design (QbD) principles to define design space and control strategy.
  • Screen manufacturing sites based on formulation and process complexity/feasibility.
  • Lead the technology transfer function to ensure successful scale-up of new products.
  • Define procedures for seamless product transfers between development and manufacturing.
  • Provide subject matter expertise for pharmaceutical processes and technologies, offering guidance in tech transfer and troubleshooting.
  • Initiate and drive capacity enhancement, cost reduction, and time cycle reduction projects.
  • Review and approve departmental standard operating procedures (SOPs) to ensure compliance with current Good Manufacturing Practice (cGMP) and quality assurance (CQA) guidelines.

Requirements:

  • Expertise in formulation development of various dosage forms.
  • Hands-on experience in technology transfer and scale-up.
  • Strong understanding of regulatory guidelines such as US FDA, European Medicines Agency (EMA), and World Health Organization (WHO).
  • Excellent documentation, communication, and analytical skills.
  • Ability to work in a fast-paced, dynamic environment.
  • Project management and cross-functional coordination.

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