Analytical Head

Key Responsibilities:

1. Analytical Method Development and Verification:

• Oversee and guide analytical method development and method verification for

RCD projects.

• Provide technical support and advice to analytical scientists in the RCD lab.

2. Data Review and Quality Assurance:

• Review and ensure the quality of analytical raw data generated during product

development.

• Review and update standard operating procedures (SOPs) related to analytical

development, RCD, and quality assurance.

3. Documentation Preparation and Review:

• Prepare, draft, and/or review specifications, analytical test methods, method

development reports, method verification/validation protocols, and reports.

• Review Drug Master Files (DMFs) provided by API vendors and coordinate with

them to address any deficiencies.

• Prepare and review CMC study protocols and reports, including stability studies,

photo-stability studies, hold time studies, chiral purity, residual solvent

justification, elemental impurities risk assessment, polymorphic stability, and

technical summary reports.

4. Impurity Evaluation and Justification:

• Evaluate impurities from various sources and prepare justification reports.

5. Troubleshooting and Site Coordination:

• Troubleshoot technical issues related to analytical activities at RCD labs, CROs,

and/or CMOs/CDMOs.

• Visit these sites as needed to resolve technical issues and ensure compliance.

6. Quality Management System (QMS) Oversight:

• Review QMS documents such as change controls, incidents, deviations, and

out-of-specifications (OOS) reports for CROs and/or CMOs/CDMOs.

7. Regulatory Compliance and Queries:

• Handle and respond to all analytical queries and deficiencies from regulatory

authorities.

• Monitor updates to Pharmacopeia related to APIs, excipients, and general

chapters specific to assigned projects.

8. Assessment of External Partners:

• Assess the suitability of CROs and/or CMOs/CDMOs for project requirements

and ensure their alignment with project goals.

Qualifications:

• Education:

• Masters degree in Organic chemistry, Analytical Chemistry./Ph.D. Analytical

chemistry

• Experience:

• Proven experience in analytical chemistry 10-15 Years , with a strong

background in method development, data review, and quality assurance.

• Experience working with CROs, CMOs/CDMOs, and regulatory compliance.

• Skills:

• Hands on expertise in analytical techniques and methods,

including method development, validation, and troubleshooting,

Calibration of equipment’s. Validation of R & D batches

,Stability of products and Approvals of products as per

specification.

• Strong understanding of Pharmacopeia standards, quality management

systems, and regulatory requirements.

• Excellent documentation, communication, and coordination skills.
• Ability to manage and oversee multiple projects and tasks simultaneously.

Working Conditions:

• Laboratory and office environment.

• Occasional travel may be required for site visits and external coordination.

• Potential exposure to hazardous materials; adherence to safety protocols is required.