R L Fine Chem
Website:
rlfinechem.com
Job details:
Company Description R L Fine Chem Pvt. Ltd., established in 1984 and headquartered in Bangalore, is a fast-growing, research-focused pharmaceutical company specializing in Active Pharmaceutical Ingredients (APIs). The company operates a USFDA-approved manufacturing plant and is certified by global regulatory agencies including USFDA, PMDA, ANVISA, EDQM, and KFDA, enabling exports of over 75% of its APIs worldwide. RLFC serves more than 600 customers across 80 countries and has a strong presence in psychotropic and CNS drug substance segments. With a portfolio of over 80 APIs, the company focuses on therapeutic areas such as antidepressants, anxiolytics, antiepileptics, antipsychotics, antihistaminics, antimalarials, muscle relaxants, motion sickness, antispasmodics, and hypnotics. RLFC emphasizes safety, environmental responsibility, and operational excellence, supported by experienced teams, advanced EHS systems, and a Zero Liquid Discharge (ZLD) plant at its facilities in Gauribidanur and Hindupur.
Role Description This is a full-time, on-site Group Leader role based in Bengaluru in the pharmaceutical industry. The Group Leader will oversee analytical method development, validation, and transfer activities for APIs, ensuring compliance with global regulatory requirements and internal quality standards. Responsibilities include planning and supervising laboratory work, reviewing and approving analytical protocols and reports, troubleshooting analytical issues, and optimizing methods for robustness and efficiency. The role involves coordinating technology transfers between R&D, manufacturing, and quality units, managing a team of analysts, and ensuring adherence to GMP, data integrity, and safety practices. The Group Leader will collaborate with cross-functional teams, support regulatory submissions, and contribute to continuous improvement of analytical processes and documentation.
Qualifications
• As a skilled Professional with 16 years of diverse experience in the pharmaceutical fast pace Analytical Methods/ Research and Development experience with technical, managerial, strong leadership and team building skills.
• Overall experience in both raw materials (API and Excipients) and Finished products analytical
techniques.
• In-depth analytical knowledge in Analytical method developments, validations, Vendor method
Verifications, Method transfers and Queries from different markets and method transfer to QC.
• Responsible for approve the development reports, validation reports, analytical reports, COA
generations and STP and specifications.
• Responsible to resolve the issues in method transfers and queries from the QC plants.
• Experience in Reports preparations for method development, validations, verifications, method
transfers.
• In-depth instrument handling knowledge of HPLC, UPLC, GC, GC-MS, IC (Make: Dionex and
Metrohm), Dissolution apparatus, KF, SOR, FT-IR, PSD and UV Spectrophotometer, etc.
• Responsible for the QMS operations, QMS, EPIQ and Chemia documentation practices and
maintenance of Narcotic consumption records.
• Built and lead cross functional teams (RAD, CRD,FRD, XRD, ICP-MS, LC-MS, etc.) through active team
work to meet objectives and to obtain maximum productivity with aggressive timelines.
- Demonstrated management and interpersonal skills to lead a vibrant and productive analytical
department, bringing high quality/compliance standards in the department.
Experienced Areas:
• Method Development
• Method Validations
• QC Method Transfers
• Regulatory Queries Response
• Certificate of analysis
• Calibration of Instruments
• Analytical Quality and Compliance
• Quality assurance
• Deviation/ Investigation/Incidents
• Leadership
• Excellent people management skills
• Lab Startup & Management
• Project management
• Team building and Training
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