Senior Product Development Specialist

22 hours ago

Kolkata, West Bengal, India beBeeDevelopment Full time ₹ 12,00,000 - ₹ 18,00,000
Product Development Leader

Purpose:

We are seeking an experienced Product Development Leader to oversee the development of new products and optimize existing formulations for regulated markets. This role involves leading the execution/development of new formulations by investigating API characteristics, defining material characteristics, performing required testing, and conducting scale-up studies.

Key Responsibilities:

  • Understand project scope, define activities and timelines, and ensure periodic monitoring and timely completion.
  • Lead the execution/development of new formulations, including investigating API characteristics, safety, and compatibility with other ingredients.
  • Identify resource requirements for projects, including materials, manpower, and machine change parts.
  • Develop R&D plans and experimental designs using 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 strict lab GMP systems and practices.
  • Review lab experiment notebooks and prepare/review technology transfer documents.
  • Liaise and coordinate with technology transfer teams and production teams to ensure seamless technology transfer.
  • Program for the optimization of existing product performance by investigating API characteristics and finished products.
  • Monitor stability protocols, evaluate results, and advance further for product development activity.
  • Communicate with various departments to ensure timely completion of projects.
  • Prepare departmental SOPs, manuals, and guidelines documents as needed.
  • Monitor IQ, OQ, and 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 and systems.
  • Maintain raw materials and finished goods storage and destruction procedures and update RLD samples inventory.
  • Participate in departmental audits and ensure compliance to recommendations.
  • Stay updated on the latest developments in technology, conceptual thinking, presentation, and communication skills.

Qualifications & Pre-Requisites:

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

Benefits:

The ideal candidate will have a strong background in formulation development, excellent leadership skills, and the ability to work effectively in a team environment.

Others:

The company offers a competitive salary and benefits package, along with opportunities for professional growth and development.

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