<h3>Job Description</h3><div>Job Description<div>Description:Company DescriptionNevakar 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.Requirements:ResponsibilitiesUnder 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 experience3 - 4 years minimum experience supporting Analytical R&D in regulated industry, familiarity with ICH Guidelines, and world pharmacopeias (USP, EP) are preferred.Technical SkillsA 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</div></div>

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. Requirements 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

The Opportunity:Avantor, a Global Fortune 500 company is looking for a dedicated Research Scientist - Biopharma Upstream Processes to optimize our Biopharma Production organization. This Bridgewater, NJ/ Innovation Center role is full-time, on-site. Research Scientist, Scientist, Research, Process, Analytical, Manufacturing, Technology

<h3>Job Description</h3><div>Job Description<div>Solaris Pharma Corporation is a leading generic corporation with the vision of improving the patients quality of life through development of niche pharmaceutical products. Solaris Pharma Corporation has a fully equipped Research & Development facility with expertise in the development of generic and specialty products. Solaris Pharma Corporation develops specialty dermatology products that have a relatively high barrier to entry due to manufacturing complexities and high-end clinical patient study demands. With a thorough knowledge of the development life cycle and well-trained, committed scientific personnel, Solaris Pharma Corporation has streamlined processes that are efficient in reducing development costs and shortening timelines, without compromise in quality. Solaris Pharma Corporation is currently engaged in the development of several generic dermatology products and is committed to establish itself as a pacesetter in dermatology pharmaceuticals. Solaris Pharma Corporation is seeking an Analytical Scientist with 3-5 years experience within the pharmaceutical industry. Responsibilities: Research Scientist III, Analytical Method Development fulfills a critical role in R&D supporting the analytical development and validation of testing methods for the Analytical Department. Essential Requirements; <ul><li>Ability to use existing analytical methods or develop new or enhance existing methods to reverse engineer brand products</li><li>Drive analytical research strategy including independently managing analytical method development/validation (mostly LC, GC and LC_MS_MS preferable) for active pharmaceutical ingredients, excipients and dosage forms to be used in the analytical R&D laboratory for routine analysis. Leads high-visibility technical projects with focused deliverables. </li><li>In-depth knowledge of analytical chemistry techniques, such as spectrophotometric, drug release, chromatographic techniques and measuring physical parameters (viscosity, particle size or droplet size by laser diffraction, melting point by DSC, water content by TGA/ Karl Fischer, IR, TLC, pH meter, identification by XRPD, and other techniques).</li><li>Develop and optimize new and existing analytical methods for qualification and release testing of products. Interpret and communicate complex experimental results, present technical findings to internal R&D & management teams and document findings in internal technical reports and/or external publications.</li><li>Respond to internal and external customers independently </li><li>Conduct independent assessment of method performance to address scientific questions or problems. Drive scientific and technical innovation, including through external collaboration and partnership.</li><li>Generate well-structured, accurate technical documents reporting the results obtained in his/her experiments and the conclusions that can be withdrawn from them including relevant recommendations for next steps.</li><li>Stay abreast of new developments in analytical technologies. Contribute to improvement in laboratory operations to increase efficiency and GMP compliance.</li><li>Participate and lead scientific discussions on projects with cross-functional team.</li><li>Excellent communication, written and verbal to write up and communicate conclusions, interact with research personnel in strategy sessions and, one-on-one conversations.</li><li>Strong team player, flexible and ability to adapt to fast-paced work environment.</li><li>Ability to lead projects and meet deadlines.</li><li>Use of rigorous analytical methods to solve difficult technical and compliance problems with effective solutions. </li></ul>Specialized Knowledge LC-MS-MS and Raman, ICP-MS, Mastersizer is preferable. Experience in writing the standard operating procedures (SOPs) and test methods. Experience with regulatory document compilation. Professional/Education Requirements 3-5 years experience or more in analytical R&D development in a pharmaceutical company Masters or Ph. D. in Analytical or Organic Chemistry (preferred) or another relevant field | </div></div>

<h3>Job Description</h3><div>Job Description<div><div>Solaris Pharma Corporation is a leading generic corporation with the vision of improving the patient’s quality of life through development of niche pharmaceutical products. Solaris Pharma Corporation has a fully equipped Research & Development facility with expertise in the development of generic and specialty products. Solaris Pharma Corporation develops specialty dermatology products that have a relatively high barrier to entry due to manufacturing complexities and high-end clinical patient study demands. With a thorough knowledge of the development life cycle and well-trained, committed scientific personnel, Solaris Pharma Corporation has streamlined processes that are efficient in reducing development costs and shortening timelines, without compromise in quality.  Solaris Pharma Corporation is currently engaged in the development of several generic dermatology products and is committed to establish itself as a pacesetter in dermatology pharmaceuticals.  Solaris Pharma Corporation is seeking an Analytical Scientist with 3-5 years’ experience within the pharmaceutical industry. Responsibilities: Research Scientist III, Analytical Method Development fulfills a critical role in R&D supporting the analytical development and validation of testing methods for the Analytical Department.   Essential Requirements;</div><ul><li> Ability to use existing analytical methods or develop new or enhance existing methods to reverse engineer brand products </li><li>Drive analytical research strategy including independently managing analytical method development/validation (mostly LC, GC and LC_MS_MS preferable) for active pharmaceutical ingredients, excipients and dosage forms to be used in the analytical R&D laboratory for routine analysis. Leads high-visibility technical projects with focused deliverables.      </li><li>In-depth knowledge of analytical chemistry techniques, such as spectrophotometric, drug release, chromatographic techniques and measuring physical parameters (viscosity, particle size or droplet size by laser diffraction, melting point by DSC, water content by TGA/ Karl Fischer, IR, TLC, pH meter, identification by XRPD, and other techniques). </li><li>Develop and optimize new and existing analytical methods for qualification and release testing of products. Interpret and communicate complex experimental results, present technical findings to internal R&D & management teams and document findings in internal technical reports and/or external publications. </li><li>Respond to internal and external customers independently  </li><li>Conduct independent assessment of method performance to address scientific questions or problems. Drive scientific and technical innovation, including through external collaboration and partnership. </li><li>Generate well-structured, accurate technical documents reporting the results obtained in his/her experiments and the conclusions that can be withdrawn from them including relevant recommendations for next steps. </li><li>Stay abreast of new developments in analytical technologies. Contribute to improvement in laboratory operations to increase efficiency and GMP compliance. </li><li>Participate and lead scientific discussions on projects with cross-functional team. </li><li>Excellent communication, written and verbal to write up and communicate conclusions, interact with research personnel in strategy sessions and, one-on-one conversations. </li><li>Strong team player, flexible and ability to adapt to fast-paced work environment. </li><li>Ability to lead projects and meet deadlines. </li><li>Use of rigorous analytical methods to solve difficult technical and compliance problems with effective solutions.  </li></ul><div>Specialized Knowledge LC-MS-MS and Raman, ICP-MS, Mastersizer is preferable. Experience in writing the standard operating procedures (SOPs) and test methods. Experience with regulatory document compilation. Professional/Education Requirements  3-5 years’ experience or more in analytical R&D development in a pharmaceutical company  Masters or Ph. D. in Analytical or Organic Chemistry (preferred) or another relevant field   |  </div><div> </div></div></div>

Research Scientist Jobs in Bridgewater, NJ

Research Scientist Analytical
December 20, 2024

Research Scientist Analytical
December 16, 2024

Research Scientist Biopharma Upstream Processes
December 14, 2024

Research Scientist Biopharma Upstream Processes
December 11, 2024

Analytical Research Scientist
December 1, 2024

Analytical Research Scientist
November 24, 2024

Quick filters

Top companies

Research Scientist Jobs in Bridgewater, NJ

Research Scientist AnalyticalDecember 20, 2024

Research Scientist AnalyticalDecember 16, 2024

Research Scientist Biopharma Upstream ProcessesDecember 14, 2024

Research Scientist Biopharma Upstream ProcessesDecember 11, 2024

Analytical Research ScientistDecember 1, 2024

Analytical Research ScientistNovember 24, 2024