Team_Lead / Senior_Analytical_Chemist

Morepen Proprietary Drug Research Pvt Ltd; Medchal–Malkajgiri; On-site; INR 800,000 - 1,200,000; Full time

Job summary

A leading pharmaceutical company in India is seeking a Senior Analytical Chemist / Team Lead for their Analytical R&D department. The successful candidate will be responsible for developing and validating analytical methods, managing a team of scientists, and ensuring compliance with global regulatory standards. A Ph.D. or M.Sc. in Analytical Chemistry with significant experience is required. The position offers a full-time contract, and is well-suited for individuals looking to lead analytical projects in an innovative environment.

Qualifications

• 5-8 years of experience for Ph.D. holders or 8-12 years for M.Sc. holders in analytical chemistry.
• Strong expertise in method development and regulatory compliance.

Responsibilities

• Responsible for analytical R&D activities for new and existing API products.
• Lead and manage a team, ensuring timely project execution.
• Develop and validate analytical methods for APIs as per ICH guidelines.
• Conduct stability studies to support regulatory submissions.
• Coordinate with cross-functional teams for analytical deliverables.

Skills

Analytical method development

Regulatory compliance

Team management

Analytical instrumentation

Problem-solving skills

Communication skills

Education

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

Tools

HPLC

GC

LC-MS

GC-MS

ICP-OES

UV-Vis

FTIR

Empower

ChemStation

LIMS

Job description

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

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.
• 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.
• Exposure to impurity synthesis and structural elucidation.
• Experience in authoring analytical sections of regulatory dossiers.
• Strong understanding of data integrity and compliance expectations.
• Analytical Thinking & Decision Making.
• Leadership & Team Management (for Team Lead role).
• Communication & Interpersonal Skills.
• Project & Time Management.
• Attention to Detail and Quality Orientation.

Seniority level

• Mid‑Senior level

Employment type

• Full‑time

Job function

• Information Technology

Industries

• Pharmaceutical Manufacturing