Chief Pharmaceutical Product Developer

3 days ago

Agra, Uttar Pradesh, India beBeeFormulation Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Job Title: Formulation Development Manager

Purpose:

  • Responsible for the development of new pharmaceutical products and optimization of existing formulations.

Key Responsibilities/Deliverables:

  1. Lead on the execution/development of new formulations by investigating characteristics of API, its viability, safety and compatibility with other ingredients, defining material characteristics, performing required testing, and conducting scale-up studies.
  2. Develop R&D plans and experimental designs applying Quality by Design (QBD) principles for all new product development projects and processes.
  3. Effectively plan and coordinate execution of lab-scale up/optimization and pilot batches, ensuring strict adherence to lab GMP systems and practices.
  4. Timely review of Lab experiment notebooks, preparation, and review of technology transfer documents.
  5. Program for the optimization of existing product performance by investigating API characteristics, researching viability, safety, and compatibility of ingredients and formulas.
  6. Check stability protocols, monitor stability studies, evaluate, and interpret the results to advance further for product development activities accordingly.
  7. Liaise and communicate with various departments such as project management, analytical development, supply chain team, clinical, regulatory, and IP department as per required product development activities to ensure timely completion of projects.
  8. Prepare new departmental SOPs, manuals, and guidelines documents when required, and renew existing ones.
  9. Monitor IQ, OQ, and PQ activities of new machines, and ensure proper functioning and maintenance of all equipment and instruments including necessary training of subordinates, technicians, and housekeeping personnel.
  10. Ensure proper storage and destruction of raw materials and finished goods, and maintain up-to-date RLD samples inventory.
  11. Participate in departmental audits and ensure compliance to recommendations.

Qualifications & Pre-Requisites:

  • Master's degree in pharmacy (Pharmaceutics).
  • Must-Have Skills: Formulation development experience of Solid and Liquid Oral, preferred to have Pellets project experience.

Additional Notes:

  • The role requires extended hours/shift work based on requirement.
  • Expected to visit manufacturing sites whenever required.

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