Senior Research Scientist – R&D

Piramal Pharma Limited; Zone 1 Tiruvottiyur; On-site; INR 3,000,000 - 6,000,000; Full time

Job summary

Piramal Pharma Limited is seeking a Senior Research Scientist – R&D to lead analytical method development, validation, and transfer for APIs and intermediates. The role emphasizes GMP compliance, data integrity, and regulatory readiness, while mentoring the team and driving continuous improvement.

The candidate will oversee instrument qualification, manage complex analytical challenges, and interact with customers in technical discussions and audits, contributing to project readiness and

Qualifications

• Master's degree in Chemistry or related field.
• 15–20 years of relevant pharmaceutical analytical R&D experience.
• Experience in GMP, data integrity, and regulatory guidelines.
• Strong leadership and mentoring abilities.
• Experience with audits and technology transfer.

Responsibilities

• Lead analytical method development, validation, and transfer for APIs and intermediates.
• Oversee instrument qualification, troubleshooting, and maintenance.
• Collaborate with cross-functional teams to support regulatory submissions.
• Represent analytical science in customer meetings and audits.
• Mentor analytical scientists and drive continuous improvement.

Skills

Analytical method development

Method validation

Method transfer

GMP compliance

Data Integrity ALCOA+

Leadership

Project management

Communication skills

Education

Master's degree in Chemistry/Analytical Chemistry/Pharmaceutical Chemistry

Tools

HPLC

UPLC

GC

LC-MS/MS

NMR

Job description

Be the First to Apply Division Piramal Pharma Solutions Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. For more details, please visit : www.piramalpharmasolutions.com

Senior Research Scientist – R&D

Job Description

Lead analytical method development, validation, transfer, and laboratory activities for APIs and intermediates, ensuring GMP, Data Integrity, EHS, and regulatory compliance. Provide technical leadership in advanced analytical techniques, investigations, customer interactions, documentation, and audits, while mentoring the team and driving continuous improvement and project readiness.

Key Responsibilities

• Lead analytical method development activities for APIs, intermediates and raw materials using techniques such as HPLC, UPLC, GC, LC-MS/MS, GC-MS, and NMR.
• Plan, review, and approve analytical method validation, verification, and transfer studies in accordance with ICH, USP, EP, and other applicable regulatory requirements.
• Oversee analytical method transfer activities between R&D, QC and external laboratories to ensure successful implementation and lifecycle management.
• Ensure laboratory compliance with GMP, Data Integrity (ALCOA+), EHS requirements, SOPs, and internal quality systems while supporting regulatory inspections and customer audits.
• Manage operation, qualification, troubleshooting, and maintenance of analytical instruments, including HPLC, GC, LC-MS/MS, GC-MS, NMR and associated software.
• Provide scientific and technical leadership in investigating OOS, OOT, analytical deviations, and complex analytical challenges.
• Oversee the effective utilization and performance of advanced analytical platforms, particularly NMR, LC-MS/MS, and GC-MS, for structural characterization, impurity profiling, and process support.
• Act as the primary analytical representative during customer meetings, technical discussions, and global conference calls, providing scientific updates and project status.
• Prepare and review technical reports, protocols, specifications, analytical development reports, validation reports, and regulatory submission documents.
• Coordinate and respond to customer, regulatory, and audit-related queries with scientifically sound and timely justifications.
• Lead, mentor, and develop analytical scientists while driving continuous improvement initiatives, laboratory productivity, and technical excellence.
• Collaborate with Process R&D, Quality Assurance, Regulatory Affairs, Manufacturing, and external partners to support project milestones and commercial readiness.

Required Skills

• Strong expertise in analytical method development, validation, and transfer.
• In-depth knowledge of chromatographic and spectroscopic techniques, including Wet chemical analysis, HPLC, UPLC, HPLC-CAD, GC, LC-MS/MS, GC-MS, and NMR.
• Excellent understanding of GMP, Data Integrity, ICH guidelines, and regulatory expectations.
• Strong communication, presentation, and customer-facing skills.
• Proven leadership, team management, problem-solving, and project management capabilities.

Preferred Attributes

• Experience supporting customer audits, and technology transfer projects.
• Ability to manage multiple projects simultaneously in a fast-paced pharmaceutical R&D environment.
• Safety and Quality oriented.
• Demonstrated track record of delivering robust analytical solutions to support development and commercial manufacturing.

Qualification

Master's Degree (M.Sc.) in Chemistry, Analytical Chemistry, Pharmaceutical Chemistry, or a related discipline.

15-20 years of relevant experience in Pharmaceutical Analytical R&D, Contract Research Organizations (CROs).

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.