CHEMIST II (HPLC, Empower, GC, Dissolution, Small Molecules, Method Development, FDA, ICH, USP) in Summit, NJ at Apex Life Sciences

Date Posted: 6/20/2018

Job Snapshot

  • Employee Type:
    Full-Time
  • Location:
    Summit, NJ
  • Job Type:
    Science
  • Experience:
    Not Specified
  • Date Posted:
    6/20/2018
  • Job ID:
    860231

Job Description


CHEMIST II (HPLC, Empower, GC, Dissolution, Small Molecules, Method Development, FDA, ICH, USP)

Job Description:

  • Responsible for assisting in method development, conducting method validation, performing laboratory research and/or routine sample analysis under minimal guidance of a supervisor. 

Responsibilities will include, but are not limited to, the following: 

Assist to carry out method development, optimization and validation for the analysis of drug substances, and finished products in accordance with cGMP regulations, established protocols, and applicable SOPs.  

  • Performs troubleshooting within method guidance. 
  • Performs reference standard qualification/requalification tests. 
  • Performs release and stability testing in accordance with established methods, specifications and protocols with limited supervision. 
  • Documents laboratory work that is detailed, timely and in compliance with GLP/GMP requirements. 

Skills/Knowledge Required: 

  • Strong background in Dissolution method development and testing is a must 
  • In-depth knowledge of cGLP/GMP; applicable FDA and ICH guidances a must 
  • Familiar with USP and other compendia 
  • Working knowledge of Empower required. 
  • Must have working familiarity with cGMP practice and safety awareness for analytical laboratories.

Key techniques needed: 

  • HPLC-Waters 2695 alliance, Agilent 1290 infinity II
  • UPLC- Acquity WATERS – H-Class
  • Dissolution- Hanson, Distek, In line UV Agilent 708/850  dissolution, Pion Fiber Optic
  • Disintegration: Disitest50
  • KF Oven Coulometer-Metrohm
  • KF-756 Coulometer- Metrohm
  • Empower III- to Generate data
  • UV/Vis-8454 Agilent

FOR IMMEDIATE CONSIDERATION please email your resume to grucci@apexlifesciences.com

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EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178.