Senior Research Scientist - AR&D

Be the First to Apply

DivisionPiramal Pharma SolutionsPiramal 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

Job TitleSenior Research Scientist - AR&DJob DescriptionEssential Qualification : M.Sc (Analytical Chemistry) & (Organic Chemistry) Essential Experience : 10 to 12 Years API or CDMO industry experience are preferable.Job Summary PPL Pharma Inc. is seeking a highly motivated and experienced Senior Research Scientist for our Analytical Research & Development (AR&D) department. This role involves leading the development, validation, and transfer of analytical methods to support drug discovery and development programs.

Job Responsibilities

• Lead the design, development, optimization, and validation of analytical methods (e.g., HPLC, GC, LC-MS, UV-Vis, KF) for the characterization of raw materials, in-process samples, drug substances, and drug products.
• Perform complex analytical testing and data interpretation, troubleshooting method performance issues, and recommending solutions.
• Oversee and execute stability studies, release testing, and characterization of investigational medicinal products in accordance with ICH guidelines and regulatory requirements.
• Write and review analytical method development reports, validation protocols, and standard operating procedures (SOPs).
• Provide scientific leadership and technical guidance to junior scientists, fostering a collaborative and innovative work environment.
• Collaborate cross-functionally with process chemistry, formulation development, quality control, and regulatory affairs teams.
• Stay abreast of new analytical technologies and regulatory trends, implementing improvements and best practices within the AR&D department.
• Present scientific findings at internal meetings and contribute to regulatory submissions.
• Ensure all laboratory activities are conducted in compliance with cGMP, GLP, and company policies.

Job Qualifications

• M.Sc in Analytical Chemistry / Organic Chemistry, 10 to 12 years of relevant industry experience in pharmaceutical AR&D.
• Demonstrated expertise in a wide range of analytical techniques, particularly HPLC/UPLC, GC, and mass spectrometry (LC-MS/GC-MS).
• Strong understanding of ICH guidelines (Q2(R1), Q3A/B, Q6A, Q1A-F) and regulatory expectations for analytical method development and validation.
• Proficiency in data analysis software and LIMS systems.
• Proven ability to lead projects, mentor junior scientists, and work independently.
• Excellent written and verbal communication skills with the ability to present complex scientific information clearly and concisely.
• Strong problem-solving skills and a proactive approach to addressing technical challenges.
• Experience with statistical tools for analytical method validation and data trending is a plus.Master of Science (MSc)