Product Formulation Specialist

1 week ago

Kannur, Kerala, India beBeeFormulation Full time ₹ 1,50,00,000 - ₹ 2,00,00,000
Job Description:

Purpose

As a key member of the development team, you will be responsible for formulating and optimizing new products and existing formulations, including solid and liquid dosage forms, to meet regulatory standards in various markets.

Key Responsibilities/Deliverables:

  • Define project scope, establish timelines, and ensure timely completion by monitoring progress periodically.
  • Develop new formulations through research, defining material characteristics, performing necessary testing, and conducting scale-up studies.
  • Identify resource requirements, such as materials, manpower, and machine change parts, and analyze literature information to ensure appropriate usage throughout development.
  • Develop R&D plans and experimental designs using QBD principles for all new product development projects and processes: analyze data, provide relevant interpretation, draw valid conclusions, and make recommendations for further advancement.
  • Plan and coordinate lab-scale up/optimization and pilot BE batches while adhering to strict laboratory GMP systems and practices.
  • Review lab experiment notebooks and prepare technology transfer documents in a timely manner.
  • Coordinate with technology transfer teams and production teams to ensure seamless technology transfer by executing plant-scale-up and exhibit batches, as well as reviewing batch manufacturing and process validation documents.
  • Program for the optimization of existing product performance through investigation, research, and analysis of API characteristics and finished products.
  • Monitor stability protocols, check stability studies, and evaluate results to advance further for product development activities accordingly.
  • Communicate with various departments, such as project management, analytical development, supply chain, clinical, regulatory, and IP, to ensure timely project completion.
  • Prepare new departmental SOPs, manuals, and guidelines documents as required, and renew existing ones to maintain compliance.
  • Ensure proper functioning and maintenance of equipment and instruments, including necessary training for subordinates, technicians, and housekeeping personnel.
  • Ensure proper storage and destruction of raw materials and finished goods, and maintain an up-to-date RLD samples inventory.
  • Participate in departmental audits and ensure compliance with recommendations.
  • Stay updated on the latest developments regarding technology, conceptual thinking, presentation, and communication skills.

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