Nexus Pharmaceuticals, LLC
Analytical Scientist II
Nexus Pharmaceuticals, LLC, Lincolnshire, Illinois, United States, 60069
Description
Title:
Analytical Scientist II Full Time Location:
Lincolnshire, IL Our Company Nexus Pharmaceuticals, a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they’re needed most. Summary Nexus Pharmaceuticals, Inc. is looking to recruit an Analytical Scientist II, Research and Development to join a growing team in Lincolnshire, IL. You will play a critical role in analytical development for parenteral/ injectable drug products. This entails literature search, material procuring, laboratory studies to develop and optimize analytical methods, method validation studies, analytical testing, formulation support, document preparations for ANDA/ NDA submissions (including analytical methods, method validation and related study reports), and preparation of related FDA Deficiency responses and trouble-shooting during the drug product development. Analytical testing may include Instrumental analyses such as HPLC, GC, IC, UV, ICP-MS, LC-MS, GC-MS and FTIR as well as wet chemistry such as titrations, LOD and chemical identification tests. Responsibilities: Responsible for the development of analytical methods based primarily on HPLC and GC following a scientific approach. Method development experience in IC, GC/MS, LC/MS and ICP/MS is preferred Must be proficient with the use of laboratory instrumentation such as HPLC, GC, and UV-Vis. Knowledge of different LC detectors such as RI, ELSD, CAD and MS is preferred Complete method development and validation in a timely manner to support new product development and NDA/ANDA submissions Develop and validate analytical methods for drug substances, finished products, and excipients Must be flexible to support change in project priorities and be able to adapt to fast paced working environment Perform routine maintenance of analytical instrument Provide analytical support to formulation group in order to finalize the formulation composition and components for new products Prepare standard volumetric solutions and reagents for analytical testing Perform critical interpretation of analytical data and prepare results summary of analytical testing Peer review of data when required Write and review SOPs, Validation Protocols, Validation Reports, Quality Protocols, Test Methods, and Specifications Clear (legible), accurate, and complete documentation of test activities on approved worksheets and laboratory notebooks Perform other duties as assigned Requirements Desired Characteristics: Analytical development and method validation skills for pharmaceuticals, injectables preferred Good communication skills, both written and verbal Education or experience: PhD in Chemistry or related discipline with a minimum of 2 year of relevant experience, or MS in Chemistry or related discipline with a minimum of 5 years of relevant experience, or BS/BA in Chemistry or related discipline with a minimum of 7 years of relevant experience Experience in HPLC and GC method development and validation is required Experience in IC, and ICP/MS method development is preferred Must have experience or demonstrated ability working with minimum supervision Travel Requirements: 0-5% travel required for this role Physical Requirements: Regular (0% - 25%) exertion including standing/walking for extended periods of time Lifting/carrying more than 15 and up to 25 pounds At times low physical effort includes sitting, and operating computers or other small equipment DISCLAIMER:
The list under Role Responsibilities are not exhaustive, but are merely the most accurate lists for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change. EEOC Statement:
Nexus is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Nexus participates in E-Verify.
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Analytical Scientist II Full Time Location:
Lincolnshire, IL Our Company Nexus Pharmaceuticals, a US-based healthcare company, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they’re needed most. Summary Nexus Pharmaceuticals, Inc. is looking to recruit an Analytical Scientist II, Research and Development to join a growing team in Lincolnshire, IL. You will play a critical role in analytical development for parenteral/ injectable drug products. This entails literature search, material procuring, laboratory studies to develop and optimize analytical methods, method validation studies, analytical testing, formulation support, document preparations for ANDA/ NDA submissions (including analytical methods, method validation and related study reports), and preparation of related FDA Deficiency responses and trouble-shooting during the drug product development. Analytical testing may include Instrumental analyses such as HPLC, GC, IC, UV, ICP-MS, LC-MS, GC-MS and FTIR as well as wet chemistry such as titrations, LOD and chemical identification tests. Responsibilities: Responsible for the development of analytical methods based primarily on HPLC and GC following a scientific approach. Method development experience in IC, GC/MS, LC/MS and ICP/MS is preferred Must be proficient with the use of laboratory instrumentation such as HPLC, GC, and UV-Vis. Knowledge of different LC detectors such as RI, ELSD, CAD and MS is preferred Complete method development and validation in a timely manner to support new product development and NDA/ANDA submissions Develop and validate analytical methods for drug substances, finished products, and excipients Must be flexible to support change in project priorities and be able to adapt to fast paced working environment Perform routine maintenance of analytical instrument Provide analytical support to formulation group in order to finalize the formulation composition and components for new products Prepare standard volumetric solutions and reagents for analytical testing Perform critical interpretation of analytical data and prepare results summary of analytical testing Peer review of data when required Write and review SOPs, Validation Protocols, Validation Reports, Quality Protocols, Test Methods, and Specifications Clear (legible), accurate, and complete documentation of test activities on approved worksheets and laboratory notebooks Perform other duties as assigned Requirements Desired Characteristics: Analytical development and method validation skills for pharmaceuticals, injectables preferred Good communication skills, both written and verbal Education or experience: PhD in Chemistry or related discipline with a minimum of 2 year of relevant experience, or MS in Chemistry or related discipline with a minimum of 5 years of relevant experience, or BS/BA in Chemistry or related discipline with a minimum of 7 years of relevant experience Experience in HPLC and GC method development and validation is required Experience in IC, and ICP/MS method development is preferred Must have experience or demonstrated ability working with minimum supervision Travel Requirements: 0-5% travel required for this role Physical Requirements: Regular (0% - 25%) exertion including standing/walking for extended periods of time Lifting/carrying more than 15 and up to 25 pounds At times low physical effort includes sitting, and operating computers or other small equipment DISCLAIMER:
The list under Role Responsibilities are not exhaustive, but are merely the most accurate lists for the current job. Management reserves the right to revise the job description and to require that other tasks be performed when the circumstances of the job change. EEOC Statement:
Nexus is proud to be an equal opportunity workplace. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Nexus participates in E-Verify.
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