Sr Analytical Scientist
Description



Title: Sr. Analytical Scientist

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 a Senior Analytical Scientist, Research and Development to join a growing team in Lincolnshire, IL. You will play a critical role in analytical development for complex parenteral/ injectable drug products including peptides, liposomes, suspensions, solutions and lyophilized 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 troubleshooting during the drug product development. Analytical testing may include Instrumental analyses such as HPLC, GC, IC, UV, LC-MS, GC-MS, dissolution, particle size and FTIR as well as wet chemistry such as titrations, LOD and chemical identification tests. Experience working with ELSD, CAD, or MS detector is required. You will also be involved in performing review of analytical methods, method validation and related study reports for ANDA/ NDA submissions. Experience in analytical development of complex generics including peptides, liposomal and suspension products is required. Strong background in organic chemistry, drug release studies, and formulation reverse engineering is also required.


Responsibilities:

• Responsible for the development and validation of analytical methods based on HPLC, GC, IC, ICP-MS, LC-MS and GC-MS          following a scientific approach for complex parenteral/injectable drug products

• Participate in performing physicochemical characterization of complex drug products including suspensions, emulsions, lipid nanoparticles, and peptides

• Must be proficient with the use of laboratory instrumentation such as HPLC, GC, ICP-MS, Dissolution apparatus, particle size analyzer, LC-MS and GC-MS

• Knowledge of orthogonal LC detectors (such as RI, ELSD, CAD, MS) and various separation methods (such as size-exclusion, reverse phase, normal phase, and ion exchange) is required 

• Must have strong technical background in analytical method development and validation

• Develop and validate analytical methods for drug substances, finished products, and excipients

• Previous experience with extractable and leachable studies for container closure systems, manufacturing components, and drug products is preferred

• Support product development by providing scientific rationale and conducting studies to determine the root cause and address product development issues

• Complete method development and validation in a timely manner to support new product development and NDA/ANDA submissions

• Provide guidance to junior team members in analytical development and validation

• Participate in cross-functional team discussions with Formulation / QC / QA / Regulatory departments on various tasks related to new product development projects and provide scientific and technical expertise

• Must be flexible to support change in project priorities and be able to adapt to fast paced working environment

• Provide analytical support to formulation group in order to finalize the formulation composition and components for new drug products

• Perform critical interpretation of analytical data and effectively communicate technical information orally and in written reports

• Prepare technical presentations with critical findings from analytical method development studies and present conclusions to senior management

• Write and review SOPs, Policies, Validation Protocols, Validation Reports, Method Development Technical Reports, Test Methods, and Specifications

• Prepare standard volumetric solutions and reagents for analytical testing

• Perform routine maintenance of analytical instruments

• Train new team members on analytical instruments

• Peer review of data when required

• 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 especially complex injectables 
  • Good communication skills, both written and verbal


Education or experience:

  • PhD in Chemistry or related discipline with a minimum of 3 years of relevant experience, or
  • MS in Chemistry or related discipline with a minimum of 7 years of relevant experience, or
  • BS/BA in Chemistry or related discipline with a minimum of 9 years of relevant experience
  • Experience in HPLC and GC method development and validation is required 
  • Experience in IC, GC/MS, LC/MS, particle size analysis and dissolution is required
  • ICP/MS method development experience is preferred
  • Experience in the characterization of lipid nanoparticle is preferred
  • Must have experience or demonstrated ability working with minimum supervision


Travel Requirements:

  • 0-15% 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.