Position HR038 – Principal Scientist – Chromatography

Location: Bridgewater, NJ

Company Description

Nevakar is a specialty injectable bio-pharmaceutical development company, based in Bridgewater, New Jersey.

Products targeted for development by Nevakar are expected to address unmet clinical and commercial needs of currently available molecules, and thereby offer value proposition to patients, prescribers and payors. These products will be filed with FDA, primarily under 505(B)(2) regulatory pathway.

Position Summary

The Principal Scientist will lead a group of analytical scientists that is responsible for design and development of analytical test methods for raw materials and drug products. The primary focus of this position will be on chromatographic methods utilizing different types of detection, including mass spectrometry. The successful candidate is expected to bring expert-level knowledge of modern analytical methodologies, to improve R&D efficiency by accelerating method development and to ensure timely delivery of high-quality methods being ready for transfer and validation. This position requires both direct participation in and supervision of analytical activities in support of pre-formulation and early formulation development. The incumbent will perform job functions in full compliance with applicable regulations and standard operating procedures. This position will report to the Director, Analytical R&D, and is located in Bridgewater, NJ.

Responsibilities

Provide technical expertise to make sure that efficient and validation-ready test methods are delivered at early stages of product development.

Spearhead efforts to implement modern techniques, methodologies and analytical QbD at early stages of the analytical method development cycle.

Directly participate in experiment design and execution, data review, preparation of protocols and reports.

Manage daily activities of the group members and ensure delivery of high quality data through personnel training and development.

Enhance team productivity, build strong working relationships, and foster collaboration between Analytical and Formulation team members.

Qualifications

A Ph.D. degree in Analytical Chemistry or related field with 8+ years of experience, or an M.S. with 12+ years of experience, or equivalent combination of education and experience is required.

6 years minimum experience in development of analytical test methods and method implementation in support of fast-paced product development within a regulated industry, familiarity with ICH Guidelines and world pharmacopeias (USP, EP) are strongly preferred.

Experience in supervising a team of scientists, including Ph.D. level scientists, is required.

Technical Skills

Expertise in liquid chromatography is a must; demonstrated experience with related techniques (GC, TLC) and hyphenated techniques (LC-MS-MS, LC-NMR, GC-MS, LC-ICP-MS, etc.) is preferred.

Understanding of analytical QbD principles and experience in implementing those is a plus.

Demonstrated experience in developing and validating chromatographic methods utilizing different mechanisms of separation is expected.

Working knowledge of physical and organic chemistry as pertained to LC method development, drug product stability studies and drug degradation pathways is highly desired.

Hands-on experience with different chromatography systems, UHPLC in particular, and software are highly desired; knowledge of the Empower software is a plus.

Understanding of regulatory requirements pertaining to test method development and validation for injectable and ophthalmic products is required.

Demonstrated ability to work on multiple projects and to lead a team comprised of scientists with diverse educational background and experience is required.

Excellent written and verbal communication skills as well as attention to detail are required.