Analytical Research and Development Manager
2 weeks ago
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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