Product Development Leader

1 day ago

Malappuram, Kerala, India beBeeDevelopment Full time ₹ 15,00,000 - ₹ 22,00,000

Product Development Manager Role

Purpose:

We are seeking a seasoned Product Development Manager to spearhead the creation of new products and optimization of existing formulations. This individual will be responsible for developing product lines, including Solid and Liquid Dosage forms such as Tablets, Capsules, Solutions, Suspensions, Pellets, MUPS etc., for regulated markets like US, Europe and ROW.

Key Responsibilities:

  • Understand project scope, define activities and timelines, and ensure timely completion.
  • Lead on the execution/development of new formulations by investigating API characteristics and viability, safety, and compatibility with other ingredients.
  • Identify resource requirements and assimilate literature information collected by project teams.
  • Develop R&D plans and experimental designs applying QBD principles for all new product development projects and processes.
  • Plan and coordinate lab scale up/optimization and pilot BE batches ensuring adherence to lab GMP system and practices.
  • Review Lab experiment notebooks and prepare technology transfer documents.
  • Liaise with technology transfer team/production team to ensure seamless technology transfer.
  • Program for the optimization of existing product performance by investigating API characteristics and finished products.
  • Evaluate stability protocols, monitor stability studies, and interpret results to advance product development.
  • Liaise with various departments to ensure timely completion of projects.
  • Prepare departmental SOPs, manuals, and guidelines documents.
  • Monitor IQ, OQ, and PQ activities of new machines and ensure proper functioning & maintenance of equipment & instruments.
  • Ensure proper training of subordinates, technicians, and housekeeping personnel on various equipment, instruments, and systems.
  • Ensure proper storage & destruction of raw materials & finished goods and maintain up-to-date RLD samples inventory.
  • Participate in departmental audits and ensure compliance to recommendations.

Requirements:

  • Master in Pharmacy (Pharmaceutics)
  • Formulation development experience of Solid & Liquid Oral; preferred to have Pellets project experience.

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