Sr Research Scientist 1 at NEVAKAR INJECTABLES INC

Bridgewater Township, New Jersey, United States -

Full Time

Start Date

Immediate

Expiry Date

07 Aug, 26

Salary

130000.0

Posted On

09 May, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Analytical Method Development, Method Validation, HPLC/UHPLC/GC, Empower Software, Chromatographic Method Optimization, Parenteral Dosage, Ophthalmic Drug Products, ICH Guidelines, USP/EP Pharmacopeias, Analytical QbD, Technical Reporting, Data Integrity, ELN/LIMS, ANDA/505b2 Programs, Regulatory Compliance, Laboratory Management

Industry

Pharmaceutical Manufacturing

Description

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.

Responsibilities

Lead the development, optimization, and validation of analytical methodologies for injectable and ophthalmic drug products. Perform analytical testing to support formulation development and prepare high-quality technical documentation and reports.