Product Development Director

2 days ago

Thoothukudi, Tamil Nadu, India beBeeProduct Full time ₹ 14,34,567 - ₹ 23,45,678
Job Title:

Director of Quality Assurance and Product Development

Key Responsibilities:
  • Oversee the development of quality assurance processes across research and development and commercial operations.
  • Establish robust stage gate systems to ensure quality products are designed, commercially viable, and scalable.
  • Design and conduct experiments with R&D teams using DOE and hypothesis testing.
  • Develop protocols for experiments and process development, evaluating performance between R&D and pilot plant levels.
  • Ensure smooth technology transfer from R&D to pilot plants and sites, sharing relevant documents and QA technical knowledge.
  • Manage overall DQA and Kilo Lab budgets, including capital and operating expenses, talent acquisition and retention.
  • Ensure compliance with SOPs, policies, standards, regulatory requirements, and customer needs.
  • Utilize in-depth knowledge of crystallization principles, techniques, and equipment, including batch and continuous methods.
  • Study and improve material flowability and free-flow characteristics of active pharmaceutical ingredients and powders.
  • Establish a system to analyze and enhance bulk density, compressibility, and particle shape of materials.
  • Implement strategies for particle size engineering, including micronization, granulation, and agglomeration.
  • Design and conduct advanced physical characterization of APIs and ingredients, including particle size distribution, morphology, porosity, and surface area analysis.
  • Set up a process to utilize SEM, TEM, XRD, DLS, and laser diffraction for material evaluation.
  • Expertly define and set process conditions, including relative humidity, for handling hygroscopic materials, their packing configuration, and storage conditions to prevent lumping and agglomeration issues.
  • Possess strong analytical and problem-solving skills, including ARD and analytical instrument knowledge, with the ability to analyze complex data and identify process optimization opportunities.
  • Ensure smooth technology transfer of crystallization and powder processing technologies.
  • Coordinate with business, technology absorption cell, site QA, and internal CFTs to ensure timely closure of stage gate processes, review, and sign-off of tech packs, and release to sites.
  • Strong project management skills, prioritizing tasks, managing timelines, and delivering results under tight deadlines.
  • Generate monthly, weekly, and periodic DQA reports, reviewing them with management, and highlighting quality-related issues in new projects with areas for improvement.
Requirements:
  • Master's degree in Chemistry or Pharmacy.
  • 16-24 years of experience in API/Intermediate/Fine Chemical Industry.
  • Sound knowledge of Fine Chemicals and DQA, with good understanding of product development at R&D stages.
Personal Characteristics:
  • Openness and transparency.
  • Willingness to learn and grow, dynamic, self-driven.
  • Work towards excellence in regulatory filing and compliance across regions.
  • Self-motivated, working towards achievement of organizational goals.

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