Pharmaceutical Process Development Manager

17 hours ago

Madurai, Tamil Nadu, India beBeeFormulation Full time ₹ 15,00,000 - ₹ 25,00,000
Job Title: Pharmaceutical Process Development Manager

This is an exciting opportunity to join our team as a Pharmaceutical Process Development Manager.

Job Description:

  • Lead the development of new pharmaceutical processes, utilizing technical expertise and project management skills to ensure successful scale-up and launch of new products within allotted timelines.
  • Evaluate manufacturing processes using Design of Experiments (DoE) and Quality by Design (QbD) principles to define design space, control strategy, critical/key parameters, and identify process risks.
  • Screen manufacturing sites based on formulation and process complexity/feasibility, ensuring seamless product transfers between development and manufacturing.
  • Develop and implement standards for formulation technology transfer, acting as a point of contact for formulation technology transfer activities with Cross-Functional Teams (CFTs).
  • Initiate, drive, and facilitate capacity enhancement, cost reduction, and time cycle reduction projects, leveraging expertise in formulation development and process optimization.
  • Review and approve departmental Standard Operating Procedures (SOPs) to ensure compliance with current Good Manufacturing Practices (cGMP) and Critical Quality Attributes (CQA) guidelines.

Required Skills and Qualifications:

  • Expertise in formulation development of various dosage forms, with strong knowledge of process optimization and hands-on experience in technology transfer and scale-up.
  • Strong understanding of regulatory guidelines, including USFDA, EMA, and WHO regulations.
  • Excellent documentation, communication, and analytical skills, with ability to work in a fast-paced, dynamic environment.
  • Project management and cross-functional coordination skills, with ability to lead teams and collaborate effectively.

Benefits:

  • Opportunity to develop and implement innovative pharmaceutical processes and technologies.
  • Collaborative work environment with cross-functional teams.
  • Professional growth and development opportunities.

Others:

  • Competitive compensation and benefits package.
  • Opportunities for professional growth and development.

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