Sr Research Scientist 1

Description

Position Summary

The Research Scientist will play a key role in advancing Nevakar’s R&D initiatives by contributing to critical analytical development activities. Working with a high degree of independence (and minimal supervision), this individual will lead and support test method development, method qualification/validation, and analytical testing to drive formulation development forward.

This role involves hands-on data analysis, interpretation, and the preparation of clear, high-quality technical reports and documentation. The position partners closely with the Formulation Development team, making a direct impact on product development efforts.

The successful candidate will operate in a fast-paced, science-driven environment, ensuring strict adherence to OSHA guidelines, FDA regulations, and internal standard operating procedures at all times.

Responsibilities

• Under limited supervision, developing and optimizing fit-for-purpose analytical methodologies across early through late-stage product development for injectable and ophthalmic drug products.
•  Independently develop, optimize, and implement fit-for-purpose analytical methods supporting early- through late-stage development of injectable and ophthalmic drug products.
• Design and execute pre-validation and validation studies to ensure analytical methods meet regulatory and scientific requirements.
• Perform analytical testing to support formulation development, interpreting results to deliver actionable insights and guidance to cross-functional teams.
• Review and verify data, including co-workers’ calculations and reports, to ensure accuracy, quality, and data integrity.
• Evaluate compendial and published methods, contributing to continuous improvement and innovation in analytical development.
• Accurately document and present analytical results in approved notebooks, logbooks, and technical reports.
• Maintain laboratory readiness by managing inventory of chemicals, glassware, and materials.
• Ensure laboratory equipment and instruments are properly maintained, calibrated, and clean to support high-quality analytical work.

Requirements

•  M.S. degree in Analytical Chemistry or related field with 7+ years of experience or a bachelor’s degree with 9+ years of experience
• 3 - 4 years minimum experience required supporting Analytical R&D in regulated industry, familiarity with ICH Guidelines, and world pharmacopeias (USP, EP) are preferred.
•  A proven track record of optimizing and developing chromatographic methods by using experimental approaches and/or software-based tools is required.
• Hands-on experience with Waters or Agilent HPLC/UHPLC/GC chromatographic systems and knowledge of Empower software is strongly preferred.
• Primary experience in an R&D environment (as opposed to a QC environment) is strongly preferred, including experience in method development for ANDA and/or 505b2 programs, with an appreciation of fast-paced development workflows. 
• Significant experience in the validation of test methods both from a design and execution perspective is required, including having a thorough understanding of regulatory requirements. Work experience in parenteral dosage is a plus. 
• Experience in collaborating with and or leading activities with 3rd party laboratories is preferred. 
• Experience with one or more of the following method development software tools: ChromSword, ACD LC Simulator, DryLab, Fusion LC is desired; Understanding of Analytical QbD principles and experience in implementing those is a plus;
• Experience with electronic data systems (ELN, LIMS) preferred but not required. 
• Understanding of regulatory requirements pertaining to analytical testing of pharmaceutical products is required, injectable and ophthalmic product experience is preferred. 
• Good communication skills as well as attention to detail are required.