Senior Formulation Specialist

3 days ago

Nashik, Maharashtra, India beBeeFormulation Full time ₹ 15,00,000 - ₹ 25,00,000
Senior Formulation Specialist

The Senior Formulation Specialist will lead the development of new products and optimize existing formulations.

  • Leverage API characteristics, viability, safety, and compatibility with other ingredients to execute/develop new formulations.
  • Develop R&D plans and experimental designs using Quality by Design (QBD) principles for all new product development projects and processes.
  • Plan and coordinate the execution of lab scale up/optimization and pilot BE batches while adhering to lab Good Manufacturing Practice (GMP) system and practices.
  • Liaise and communicate with various departments such as project management, analytical development, supply chain team, clinical, regulatory, and intellectual property department to ensure timely completion of projects.
  • Prepare new departmental standard operating procedures (SOPs), manuals, and guidelines documents as required and renew existing ones.

Responsibilities:

  • Understand project scope, define activities, and timelines, ensuring periodic monitoring and timely completion.
  • Identify resource requirements for projects, including materials, manpower, machine change parts, and assimilate literature information.
  • Analyze data to provide relevant interpretations, draw valid conclusions, and make recommendations for further advancement in product development.
  • Timely review of lab experiment notebooks and preparation and review of technology transfer documents.
  • Program for the optimization of existing product performance by researching API characteristics and finished products.
  • Check stability protocols, monitor stability studies, and evaluate/interpret results to advance further for product development activity accordingly.
  • Monitor installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) activities of new machines and ensure proper functioning and maintenance of equipment and instruments.
  • Ensure proper training of subordinates, technicians, and housekeeping personnel on various equipment, instruments, and systems.
  • Maintain up-to-date reference listed drug (RLD) samples inventory and participate in departmental audits to ensure compliance to recommendations.

Qualifications & Pre-Requisites:

  • Master's degree in pharmacy (pharmaceutics)
  • Formulation development experience of solid and liquid oral; preferred to have pellets project experience.

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