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QC Chemist - Analytical Development in Summit, NJ at APEX Systems

Date Posted: 3/14/2019

Job Snapshot

  • Employee Type:
    Contractor
  • Location:
    Summit, NJ
  • Job Type:
  • Experience:
    Not Specified
  • Date Posted:
    3/14/2019

Job Description

Job #:  949986

We're seeking a Chemist to develop, validate, and implement analytical methods to assess physical and chemical properties of pharmaceutical materials for a top Biopharmacetuical company! 

Responsibilities: 

  • Contributes to the development of priority drug candidates through the development, validation, and implementation of analytical methods involving modern analytical instrumentation including HPLC/UPLC, GC, dissolution, FT-IR, Karl Fischer titrations, etc. 
  • Transfers validated methods to customer labs, including internal and partner-owned quality control (QC) labs. 
  • Performs testing for development and clinical materials and stability samples in accordance with established methods, specifications and protocols under supervision. 
  • Knows the fundamentals of analytical methodology and can troubleshoot instrumentation and method performance issues of routine complexity. 
  • Documents / reviews laboratory work using laboratory notebooks / worksheets and ELN that is detailed, timely and in compliance with GLP / GMP requirements. 
  • Contributes data to the preparation of high-quality technical reports as source documents for regulatory submissions. 
  • Reviews data for compliance and adherence to specifications and acceptance criteria. 
  • Communicates results according to project timelines and works with collaborators to understand project needs and contribute to overall analytical control strategy. Draws basic conclusions from data and results. 
  • Complies with Environmental Health and Safety Requirements 

Qualifications: 

  • BS in Chemistry or relevant discipline required; MS preferred
  • 3+ years cGMP / GLP pharmaceutical laboratory experience 
  • Hands-on experience with separations techniques (HPLC, UPLC, GC, etc.) and instrumentation software a ,ist
  • Familiar with HPLC, dissolution, FT-IR, UV/VIS spectrophotometry, titrations, etc. required
  • Experience in the development and performance of analytical tests for a variety of drug substances and products including solid oral dosage forms and injectables is a plus. 
  • Strong verbal and written communication skills, and interpersonal skills as a team player. 
  • Willing to work in an environment where individual initiative, accountability to the team, and professional integrity are required.  
  • Familiar with cGMP/GLP guidelines, ICH, FDA, and EMA guidelines. 
  • Familiar with USP and other compendia. 
  • Recognizes analytical test problems, can investigate problems and take appropriate steps to resolve and communicate issues. Recognizes technological limitations and addresses them usually under guidance of lab manager/direct supervisor. 
  • Demonstrated ability to conduct and document analytical laboratory experiments under minimal supervision.

***For immediate consideration, please email your updated resume to woodbridgels@apexlifesciences.com with 'QC Chemist Analytical Development' in the subject line.

 

 

 

 

 

 

 

 

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 844-463-6178