Senior Director of Product Design

2 days ago

Mysore, Karnataka, India beBeeQualityAssurance Full time ₹ 1,80,00,000 - ₹ 2,40,00,000
Developmental Quality Assurance Lead

This role focuses on leading quality systems across research and development stages, ensuring first-time-right product designs that are commercially viable and scalable.

  • The successful candidate will be responsible for the overall developmental Quality Assurance function, including analytical assurance, across the R&D & Development Quality of new products.
  • Key responsibilities include setting up process systems for new products at R&D and Pilot stages to ensure right first-time quality products are designed.
  • Designing experiments, DOE, and hypothesis studies to conduct experiments with R&D and Technology teams.
  • Designing protocols for experiments, developing processes, studying robustness, evaluating process performance between R&D to Pilot plant and site level.
  • Playing a key role in technology transfer from R&D to Pilot plant and Site level, sharing relevant documents and ensuring QA – tech transfer to sites.
  • Managing the overall DQA & Kilo Lab budget, Capex, opex, hiring, and retention of talent.
  • Ensuring compliance of SOPs, Policies, standards, guidelines, regulatory, and customer requirements.
  • In-depth knowledge of crystallization principles, techniques, and equipment, including batch and continuous crystallization methods.
  • Studying and improving material flowability and free-flow characteristics of API / ingredients, powders, supplements.
  • Setting up a system to analyze and enhance bulk density, compressibility, and particle shape, particle size of materials, angle of repose.
  • Implementing strategies for particle size engineering, including micronization, granulation, and agglomeration.
  • Designing to conduct advanced physical characterization of APIs, ingredients, including particle size distribution, morphology, porosity, and surface area analysis.
  • Setting up a process to utilize techniques like SEM, TEM, XRD, DLS, and laser diffraction for material evaluation.
  • Expertise in defining and setting process conditions, including RH for Hygroscopic materials handling, their packing configuration and storage conditions to avoid lumping and agglomeration issues.
  • Strong analytical and problem-solving skills, including ARD, (Analytical/QC /instruments knowledge) with the ability to analyze complex data and identify process optimization opportunities.
  • Ensuring smooth technology transfer of crystallization and powder processing technologies.
  • Coordinating with Business, Technology absorption cell, site QA, and internal CFTs to ensure smooth functioning, closing of stage gate process in the system timely, reviewing and signing off of tech-pack and releasing it to site.
  • Strong project management skills, prioritizing tasks, managing timelines, and delivering results under tight deadlines.
  • Generating and reviewing monthly, weekly, and periodic DQA reports with management and highlighting quality-related issues in new projects along with areas of improvement.
Required Skills and Qualifications
  • M. Sc /M.Pharma– Chemistry degree
  • 16-24 years of experience in API/Intermediate/Fine chemical Industry
  • Sound knowledge of Fine Chemical, DQA is a must, with good knowledge of product development at R&D stage
Benefits

This position offers an opportunity to work in a fast-paced environment, collaborate with experienced professionals, and develop expertise in Quality Assurance leadership.

Others

Please note that we value diversity and inclusion in our organization. We encourage applicants from diverse backgrounds to apply.

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