Senior Scientist AR&D

Job Title:

Senior Scientist, Analytical R&DJob Description

The Senior Scientist, Analytical R&D plays a key role in supporting analytical development and testing within a fast-paced generic pharmaceutical environment. This role focuses on hands-on analytical testing of active pharmaceutical ingredients, excipients, in-process materials, and finished dosage forms, ensuring compliance with cGMP and global regulatory guidelines. The position emphasizes strong execution of established laboratory procedures, accurate documentation, and effective use of modern analytical instrumentation to support product development, release, and qualification activities.

• Develop and validate analytical methods, primarily using LC and GC, for active pharmaceutical ingredients, excipients, and dosage forms to support routine analysis in the Analytical R&D laboratory.
• Optimize new and existing analytical methods for qualification and release testing of pharmaceutical products.
• Perform hands-on analytical testing of APIs, excipients, in-process materials, and finished products using HPLC/UPLC, GC, UV-Vis, IR spectroscopy, TLC, MS, and other standard analytical techniques.
• Execute established laboratory procedures independently, including assays, related-compound testing, dissolution, residual solvent analysis, and physical testing such as density, viscosity, and particle size.
• Accurately document analytical data, calculations, chromatograms, observations, instrument outputs, and test results in accordance with cGMP and applicable regulatory guidelines.
• Conduct routine calibration, verification, and basic maintenance of laboratory equipment to ensure reliable performance and data integrity.
• Provide timely responses to internal and external inquiries related to analytical methods, test results, and laboratory capabilities.
• Provide training and guidance to laboratory analysts and group members to build technical capabilities and expand the analytical skill set of the team.
• Ensure that analytical procedures are technically sound and conform to appropriate standards of identity, strength, quality, and purity of components.
• Evaluate, recommend, and implement new analytical technologies and instrumentation to enhance testing efficiency and capability.
• Stay current with new developments in analytical technologies and contribute to continuous improvement of laboratory operations and GMP compliance.
• Lead team members on assigned projects when required, providing technical direction and ensuring project milestones are met.
• Participate in and lead scientific discussions on projects with cross-functional teams, contributing analytical expertise to development strategies.
• Assist with reverse engineering of reference products by developing, qualifying, and applying analytical methods to characterize dosage forms.
• Support regulatory document compilation by contributing method descriptions, validation summaries, and analytical data as needed.
• Execute method-development and validation experiments under the direction of responsible scientists, providing analytical support rather than independent design.
• Perform testing of transdermal patches and other specialized dosage forms for drug content, purity, degradation products, adhesive properties, and visible defects, with training provided as needed.
• Contribute to improvement initiatives that increase laboratory efficiency, robustness of methods, and adherence to cGMP.

• Bachelors degree (BA/BS) in Chemistry, Pharmacy, Pharmaceutical Sciences, or a closely related scientific discipline.
• Masters degree (MS/MA) in Chemistry, Pharmaceutical Sciences, or related field preferred;
  Ph.D. in pharmaceutical sciences or related subject is an additional advantage.
• Approximately 8…