Nevakar Injectables, Inc.
Research Scientist - Analytical
Nevakar Injectables, Inc., Trenton, New Jersey, United States
Company Description
Nevakar Injectables 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.
The
Research Scientist
position will support Nevakar R&D by supporting various activities (independently, but with limited supervision) within the analytical development group including test method development, method qualification/validation, testing of various samples in support of formulation development, performing data analysis and review and preparation of reports and other technical documents. This position will work closely with Formulation Development team members. The successful candidate will perform job functions in accordance with the OSHA guidelines and ensure full compliance with FDA regulations and standard operating procedures. 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. Under limited supervision, designing and executing appropriate pre-validation and/or validation studies required to support analytical methodologies. Testing various samples in support of formulation development, subsequently followed by interpretation of results to provide meaningful guidance to the team. Verifies co-workers calculations in notebooks/logbooks and verifies results in reports and/or appropriate systems to check for accuracy and integrity of data. Evaluates compendial and other published methods, supports new method development activities. Interprets and tabulates results of analysis. Records the results in approved notebooks, reports and logbooks. Helps maintain inventory of glassware, chemicals and materials needed for chemical analysis. Required to maintain and clean laboratory instruments and equipment. Required to design and/or execute departmental methods, protocols and SOPs. Required to assist in writing, reviewing, or revising procedures. Perform other laboratory related miscellaneous duties as required. Qualifications: A 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 supporting Analytical R&D in regulated industry, familiarity with ICH Guidelines, and world pharmacopeias (USP, EP) are preferred. Technical Skills 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. Equal Opportunity Employer Minorities/Women/Veterans/Disabled #J-18808-Ljbffr
Research Scientist
position will support Nevakar R&D by supporting various activities (independently, but with limited supervision) within the analytical development group including test method development, method qualification/validation, testing of various samples in support of formulation development, performing data analysis and review and preparation of reports and other technical documents. This position will work closely with Formulation Development team members. The successful candidate will perform job functions in accordance with the OSHA guidelines and ensure full compliance with FDA regulations and standard operating procedures. 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. Under limited supervision, designing and executing appropriate pre-validation and/or validation studies required to support analytical methodologies. Testing various samples in support of formulation development, subsequently followed by interpretation of results to provide meaningful guidance to the team. Verifies co-workers calculations in notebooks/logbooks and verifies results in reports and/or appropriate systems to check for accuracy and integrity of data. Evaluates compendial and other published methods, supports new method development activities. Interprets and tabulates results of analysis. Records the results in approved notebooks, reports and logbooks. Helps maintain inventory of glassware, chemicals and materials needed for chemical analysis. Required to maintain and clean laboratory instruments and equipment. Required to design and/or execute departmental methods, protocols and SOPs. Required to assist in writing, reviewing, or revising procedures. Perform other laboratory related miscellaneous duties as required. Qualifications: A 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 supporting Analytical R&D in regulated industry, familiarity with ICH Guidelines, and world pharmacopeias (USP, EP) are preferred. Technical Skills 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. Equal Opportunity Employer Minorities/Women/Veterans/Disabled #J-18808-Ljbffr