Formulation Expert

3 days ago

Kollam, Kerala, India beBeeProductDevelopment Full time ₹ 10,00,000 - ₹ 15,00,000
Senior Product Development Specialist

This role is responsible for the development of new products and optimization of existing formulations, including Solid and Liquid Dosage forms (Tablets, Capsules, Solutions, Suspensions, Pellets, MUPS etc.) for regulated markets like US, Europe and ROW.

Location: Kollam

Key Responsibilities:
  • Understand project scope, define activities and timelines, and ensure periodic monitoring and timely completion.
  • Lead on the execution/development of new formulations by investigating API characteristics, safety, and compatibility with other ingredients.
  • Identify resource requirements for projects 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.
  • Effectively plan and coordinate lab scale-up/optimization and pilot BE batches adhering to lab GMP system and practices.
  • Timely review of lab experiment notebooks and preparation/review of technology transfer documents.
  • Liaise and coordinate with technology transfer team/produciton team for seamless technology transfer and review batch manufacturing and process validation documents.
  • Program for optimization of existing product performance by investigating API characteristics and finished products.
  • Check stability protocols, monitor stability studies, and evaluate/interpret results to advance further for product development.
  • Liaise and communicate with various departments as per required product development activity.
  • Prepare new departmental SOPs, manuals, and guidelines documents as needed.
  • 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 equipment, instruments, and systems.
  • Ensure proper storage/destruction of raw materials and finished goods and maintain up-to-date RLD samples inventory.
  • Participate in departmental audits and ensure compliance to recommendations.
  • Stay updated with latest developments w.r.t. technology, conceptual thinking, presentation, and communication skills.
Requirements:
  • Master in pharmacy (Pharmaceutics)
  • Must-Have Skills: Formulation development experience of Solid & Liquid Oral; preferred to have Pellets project experience.
Additional Notes:
  • The role is expected to work in extended hours/any shift based on requirement.
  • Expected to visit manufacturing sites whenever required.

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