Senior Pharmaceutical Process Specialist

1 week ago

Ellore, Andhra Pradesh, India beBeeExpert Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

Job Title: Manager Formulation Development and Research

Key Responsibilities:
  • Design and optimize manufacturing processes for regulated markets (US, Canada, EU) 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.
  • Lead technology transfer functions with adequate project management skills to ensure successful scale-up of new products and effective launches within stipulated time.
  • Define procedures for seamless product transfers between development and manufacturing (in-house and external), 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 robust performance and timely supply.
  • Define and implement standards for formulation technology transfer and be the point contact for formulation technology transfer activities, with Cross-Functional Teams (CFTs).
  • Initiate, drive, and facilitate capacity enhancement, cost reduction, and time cycle reduction projects.
  • Review and approve departmental Standard Operating Procedures (SOPs) to ensure compliance with Current Good Manufacturing Practices (cGMP) and Compliance, Quality Assurance (CQA) guidelines, technical changes, change control, deviations, and relevant documents.
Required Skills and Qualifications:
  • Advanced degree in a relevant field (e.g. Pharmaceutical Sciences, Chemical Engineering)
  • Proven experience in manufacturing process development and optimization
  • Strong understanding of quality systems and regulatory requirements (e.g. cGMP, GMP, GDP)
  • Excellent communication and interpersonal skills
  • Ability to work effectively in a team environment
  • Strong problem-solving and analytical skills
  • Ability to prioritize tasks and manage multiple projects simultaneously
Benefits:
  • Competitive salary and benefits package
  • Opportunities for professional growth and development
  • Collaborative and dynamic work environment
  • Recognition and rewards for outstanding performance
Others:
  • Relocation assistance may be available
  • Must be authorized to work in the country where the job is located

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