Analytical Research and Development Manager

2 weeks ago


Mumbai, Maharashtra, India Inventia Healthcare Limited Full time
Job Title: Assistant General Manager

Job Description (AGM/DGM level)

Location: Thane

Experience: 18 to 20 years

Job Summary:

We are seeking an experienced Assistant General Manager to lead our Analytical Research and Development team. The successful candidate will be responsible for developing cost-saving analytical methods, qualifying and characterizing APIs, and ensuring compliance with regulatory requirements.

Key Responsibilities:

  • Develop and implement cost-saving analytical methods using QbD approach, including assay, RS, dissolution, cleaning methods, and method validation as per ICH guidelines.
  • Qualify and characterize APIs received for product development, including API DMF review for compliance to regulatory markets.
  • Lead the team in reverse engineering and establishing Q1/Q2 for products.
  • Ensure compliance with laboratory procedures, practices, and maintain laboratory equipment/instrument as per GLP, EHS, and other statutory guidelines.
  • Collaborate with Regulatory Affairs department for submission of data required for regulatory filing related to Analytical Development.
  • Set specifications for finished products and excipients for new projects assigned to the group.
  • Train and develop team members in analytical techniques and problem-solving skills.
  • Stay up-to-date with ICH guidelines and regulatory requirements, including Nitrosamine, Elemental impurity assessment, Residual solvent assessment, etc.

Requirements:

  • 18 to 20 years of experience in Analytical Research and Development.
  • Strong knowledge of QbD approach, ICH guidelines, and regulatory requirements.
  • Excellent leadership and communication skills.
  • Ability to work independently and as part of a team.
  • Strong analytical and problem-solving skills.

What We Offer:

Inventia Healthcare Limited offers a competitive salary and benefits package, as well as opportunities for professional growth and development.

How to Apply:

Please submit your resume and cover letter to [insert contact information].


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