Team_Lead / Senior_Analytical_Chemist

Job Description: Team Lead / Senior Analytical Chemist – Analytical R&D

Location: Gagillapur, Hyderabad, Telangana

Education: M.Sc. / M.Pharm / Ph.D. in Analytical Chemistry or related discipline

Experience: Ph.D.: 5 - 8 years / M.Sc.: 8 - 12 years

Position Summary

The Senior Analytical Chemist / Team Lead – Analytical R&D will be responsible for analytical research and development activities supporting new and existing API products. The role involves analytical method development, validation, impurity profiling, stability studies, and regulatory support in compliance with global regulatory guidelines such as USFDA, EMA, MHRA, and WHO.

Candidates hired as Team Lead will additionally be responsible for managing and mentoring a team, ensuring timely project execution, and acting as a technical and regulatory interface with cross-functional teams.

Key Responsibilities

Analytical & Technical Responsibilities (Applicable to Both Roles)

• Develop, validate, and optimize analytical methods for APIs and intermediates as per ICH guidelines.
• Perform impurity profiling, degradation studies, and characterization of impurities and reference standards.
• Conduct and monitor stability studies to support regulatory submissions.
• Ensure smooth analytical method transfer to Quality Control and Manufacturing units.
• Troubleshoot analytical issues and provide technical support to Manufacturing and QA teams.
• Operate, maintain, and ensure effective utilization of analytical instruments such as:
• HPLC, GC, LC-MS, GC-MS, ICP-OES, UV-Vis, FTIR, and related equipment.
• Prepare, review, and maintain analytical documentation, protocols, reports, and specifications.

Leadership & Management Responsibilities (Team Lead Role)

• Lead and manage a team of analytical scientists and analysts.
• Plan work allocation, timelines, and resource utilization for ARD projects.
• Review and approve analytical data, validation reports, and study outcomes.
• Mentor and train team members to enhance technical capability and compliance awareness.
• Coordinate with Regulatory Affairs, QA, and Manufacturing for analytical deliverables.
• Support and participate in internal, customer, and regulatory audits.

Regulatory & Compliance

• Ensure compliance with cGMP, GLP, ICH, and Data Integrity (ALCOA+) principles.
• Support preparation and review of analytical sections for DMF, ANDA, and other regulatory filings.
• Respond to regulatory queries related to analytical data.

Required Skills & Qualifications

• Strong expertise in analytical method development, validation, and stability studies.
• Hands-on experience with advanced analytical instrumentation.
• Sound knowledge of global regulatory requirements (USFDA, EMA, MHRA, WHO).
• Proficiency in analytical software such as Empower, ChemStation, and LIMS.
• Strong problem-solving, documentation, and communication skills.

Desirable Skills

• Exposure to impurity synthesis and structural elucidation.
• Experience in authoring analytical sections of regulatory dossiers.
• Strong understanding of data integrity and compliance expectations.

Key Competencies

• Analytical Thinking & Decision Making.
• Leadership & Team Management (for Team Lead role).
• Communication & Interpersonal Skills.
• Project & Time Management.
• Attention to Detail and Quality Orientation.