Bioanalytical Scientist

New Jersey, USA Req #180
Monday, January 29, 2024

Integrated Analytical Solutions, Inc. (IAS) is a GLP- and ISO-17025 compliant contract research organization (CRO) specializing in bioanalytical and analytical testing for the biopharmaceutical industry as well as a cannabis testing laboratory within the state of New Jersey.  Our laboratories are located in Hamilton, NJ.  Our company culture is built on the principles of teamwork, customer satisfaction and scientific integrity.

 

Job Summary:  Function as the scientific lead for small molecule pharmacokinetics and pharmacodynamics and/or function as the scientific lead for the cannabis testing laboratory.  Drive business and growth within the bioanalytical laboratory group and duties including but not limited to: study design, client engagement and management, method development, assay validation, sample analysis, and reporting.  Experience in a Contract Research Organization (CRO) with PK experience, specific experience with method development and validation assays and work in a regulated environment a plus.

 

Major Responsibilities:

  • Scientific lead in the development, validation, and performance of test methods using HPLC-MS/MS, HPLC-UV, GC-MS, and ICP-MS instrumentation.
  • Oversee study/test sample analysis based using established methods and procedures.
  • Operate efficiently in a regulated laboratory environment, including following SOPs and FDA regulations (ISO-17025, GLP, GCP, and cGxP).
  • Mentor and develop staff.
  • Assist in the generation of quotes and study protocols.
  • Interface with multiple groups (both internal and clients) for the successful implementation, conduct, and interpretation of studies.
  • Perform the responsibilities of Study Director with respect to bioanalytical validations and qualifications for regulated and discovery bioanalytical studies.
  • Writing final reports, communicating progress, and project issues to management and clients.

 

Preferred Experience:

  • Ph.D. in analytical chemistry (or related science) with at least 5 years of industrial experience working in bioanalytical lab, or M.S. in analytical chemistry (or related science) with at least 10 years of industrial experience working in bioanalytical lab, or M.S.
  • Special consideration will be given to those candidates with previous cannabis laboratory testing experience.
  • Experience with extraction and preparation of blood/plasma and/or tissue samples is a plus.
  • Special consideration will be given to those candidates with drug metabolism / metabolite ID experience.
  • Training and experience with instrumentation and software such as HPLC, UPLC, LC-MS/MS, GC-MS, and/or ICP-MS.
  • Training and experience working with LIMS system for data processing.
  • Experience with oversite of regulated studies including ISO-17025, FDA GLP, GMP and GCP requirements and guidance.
  • Strong written, presentation, and verbal communication skills.
  • Experience using Phoenix WinNonlin is a bonus.
  • Desire to work in a close-knit, fast-paced environment that focuses on productivity and efficiency.

 

We Offer

  • Medical, Dental & Vision Insurance
  • Short and Long Term Disability
  • Life Insurance
  • Paid Vacation, Holidays, and Sick Time
  • 401(k)

 

IAS is an equal opportunity employer. 

Other details

  • Pay Type Salary
Location on Google Maps
  • New Jersey, USA