Research And Development Scientist

GNT Page Private Limited; Haridwar; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

GNT PAGE – Elevating Careers, Empowering Industries is seeking professionals for Analytical Development Laboratory roles (Officer/Executive/Assistant Manager). The team will drive analytical method development, validation, transfer, and troubleshooting for sterile injectables and OSD formulations.

Responsibilities include data review, method transfer, regulatory documentation, and collaboration with Formulation Development, QC, and Regulatory Affairs to ensure GMP compliance and successful

Qualifications

• Hands-on experience in analytical method development and validation for pharmaceutical formulations.
• Understanding of ICH guidelines, GMP, and data integrity.
• Ability to prepare technical documentation and transfer methods.

Responsibilities

• Develop, optimize, validate, verify, and transfer analytical methods for injectable and OSD formulations.
• Perform analytical testing including assay, related substances, dissolution, and content uniformity.
• Coordinate method transfer to QA and support regulatory documentation and audits.
• Troubleshoot chromatographic issues and instrument-related problems; review data and records for accuracy.

Skills

Analytical method development

Analytical method validation

HPLC

UV-Vis spectroscopy

Troubleshooting

Cross-functional coordination

Education

M.Pharm / B.Pharm / M.Sc. in Chemistry

Ph.D. preferred for senior-level

Tools

HPLC

UV-Visible spectroscopy

Job description

JOB DESCRIPTION

Officer / Executive / Assistant Manager – Analytical Development Laboratory (ADL)

Pharmaceutical Manufacturing – Injectable & Oral Solid Dosage (OSD) Formulations

Department: Analytical Development Laboratory (ADL)

Experience: 3–9 Years, depending on designation

Qualification: M.Pharm / B.Pharm / M.Sc. in Chemistry or a relevant pharmaceutical science discipline; Ph.D. preferred for senior-level candidates

Industry: Pharmaceutical Manufacturing

Dosage Forms: Sterile Injectables and Oral Solid Dosage (Tablets and Capsules)

Job Summary

We are looking for qualified and experienced professionals for the positions of Officer / Executive / Assistant Manager – Analytical Development Laboratory (ADL) for injectable and OSD pharmaceutical formulations. The selected candidates will be responsible for analytical method development, optimization, validation, verification, transfer, and related analytical activities to support formulation development and product commercialization in compliance with applicable GMP and regulatory requirements.

Key Roles and Responsibilities

• Develop, optimize, validate, verify, and transfer analytical methods for pharmaceutical formulations, including sterile injectables, tablets, and capsules.
• Perform analytical testing, including assay, related substances, dissolution, content uniformity, and other applicable tests.
• Develop and optimize analytical methods using HPLC, UV-Visible spectroscopy, and other relevant analytical instruments.
• Conduct forced degradation studies and develop stability-indicating analytical methods, as applicable.
• Prepare, execute, review, and maintain analytical method development protocols, validation reports, analytical procedures, and method transfer documents.
• Perform analytical method validation in accordance with approved protocols and applicable ICH guidelines.
• Support analytical evaluation of formulation development batches and stability studies.
• Troubleshoot chromatographic issues, analytical discrepancies, method failures, instrument-related problems.
• Coordinate analytical method transfer to Quality Control and provide technical support during implementation.
• Review analytical data, chromatograms, calculations, raw data, and laboratory records to ensure accuracy, traceability, and data integrity.
• Ensure compliance with applicable GMP requirements, pharmacopoeial standards, SOPs, and laboratory safety practices.
• Maintain analytical instruments, reference standards, reagents, and laboratory documentation.
• Coordinate with Formulation Development, Quality Control, Quality Assurance, and Regulatory Affairs for analytical and product development activities.
• Support preparation of analytical data and technical documentation for regulatory submissions, audits, and inspections.
• Investigate analytical discrepancies and support deviation investigations, corrective and preventive actions (CAPA), and continuous improvement activities.
• Guide junior team members and coordinate laboratory activities according to experience and designation.

Required Skills and Competencies

• Hands-on experience in analytical method development and validation for pharmaceutical formulations.
• Practical knowledge of HPLC, UV-Visible spectroscopy, and chromatographic data interpretation.
• Understanding of assay, related substances, dissolution, content uniformity, and forced degradation studies.
• Knowledge of stability-indicating methods, analytical method transfer, and validation documentation.
• Understanding of applicable ICH guidelines, GMP, pharmacopoeial requirements, and data integrity.
• Strong analytical troubleshooting, technical writing, documentation, and cross-functional coordination skills.
• Ability to work with injectable and/or OSD formulations in a pharmaceutical development or manufacturing environment.

Designation-Wise Experience and Expectations

Officer – ADL

• Experience: 3–5 Years.
• Execute analytical testing, method development activities, and validation studies.
• Maintain accurate laboratory records, chromatograms, calculations, and supporting documentation.
• Support instrument operation, troubleshooting, and analytical method transfer.

Executive – ADL

• Experience: 4–6 Years.
• Independently execute analytical method development, optimization, validation, and transfer activities.
• Prepare technical protocols, reports, and analytical documentation.
• Troubleshoot analytical methods and coordinate with Formulation Development and Quality Control.

Assistant Manager – ADL

• Experience: 6–9 Years.
• Lead and coordinate analytical method development, validation, and transfer activities.
• Review technical documents and provide guidance on complex analytical troubleshooting.
• Coordinate project timelines, laboratory resources, and cross-functional activities.
• Guide junior team members and support regulatory documentation, audits, and continuous improvement.

Preferred Candidate Profile

Candidates with hands‑on experience in analytical method development and validation for injectable and/or OSD pharmaceutical formulations will be preferred. Experience in a regulated pharmaceutical manufacturing or formulation development environment, with strong technical documentation and analytical troubleshooting capabilities, will be an advantage.

GNT PAGE – Elevating Careers, Empowering Industries