Qc Scientist - Princeton, United States - NJ BIO INC

NJ BIO INC
NJ BIO INC
Verified Company
Princeton, United States

4 weeks ago

Mark Lane

Posted by:

Mark Lane

beBee recruiter
Description

JOB RESPONSIBILITIES:


  • Perform all work in a safe and compliant manner in accordance with EHS best practices and cGMP guidelines.
  • Work with management and vendors to acquire, install, and qualify new equipment.
  • Maintain, clean, calibrate, troubleshoot, and repair analytical instruments and equipment.
  • Develop and execute analytical methods for small molecules, proteins, and antibody drug conjugates.
  • Analysis of raw materials, inprocess samples, finished products, and stability samples by various analytical instruments in a GMP compliant lab.
  • Prepare standard operating procedures (SOPs), analytical test methods, protocols, reports, etc. as needed.
  • Conduct OOS, risk assessment, and root cause investigations and/or assist management with these investigations.
  • Write deviations, change controls, and CAPAs, and/or assist management with these documents.
  • Document work in laboratory notebooks and logbooks according to organizational GDP policies.
  • Write, review, and execute analytical protocols & reports for method transfers, qualifications, and validations in GMP setting.
  • Manage work outsourced to thirdparty analytical and metrology service providers.
  • Perform detailed peer review of analytical data to ensure accuracy.
  • Train and oversee junior scientists.

SKILLS:


  • Strong background in analytical sciences.
  • Ability to work independently and in a team setting.
  • Handson experience with various analytical techniques, including LC, LC-MS, spectroscopy, electrophoresis, KF, endotoxin, ELISA, etc.

EDUCATION AND EXPERIENCE:


  • BS, MS degree in chemistry, biology, biochemistry, or related discipline.
  • 04 years' experience in a GMP manufacturing or CRO setting.

PHYSICAL QUALITIES:


  • Typically requires standing and walking for entire shift.
  • Occasionally requires lifting of up to 20 pounds.
  • Frequently requires the use of a step stool.
  • Requires manual dexterity and visual abilities

WORKING CONDITIONS:


  • Laboratory and office environment.
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NJ Bio, Inc. is an equal opportunity employer.

All qualified applicants will receive consideration for employment without regard to their race, color, sex, religion, age, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability or any other characteristic protected by applicable federal, state, or local laws.

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