Scientist II, QC Spray/Particulate Laboratory

10/28/21

Princeton, NJ

1438

BS

Overview:

The purpose of this role is to perform basic tests and analysis and conduct laboratory procedures in compliance with established protocols with minimal supervision. This role will keep appropriate records, write reports, and provide information to others. The role will maintain a level of appropriate scientific knowledge in assigned area and perform scientific literature searches and evaluations as required, while understanding and complying with accepted laboratory and safety procedures. This role will apply a basic knowledge of principles/theories and concepts to develop solutions to technical problems of limited scope. This role will carry out work including the recording, evaluating, analyzing, and interpreting data. The incumbent may train new or less experienced employees. This role will ensure notebooks and reports follow regulatory guidelines and complete projects’ data review with time limits by verifying mathematical calculations, interpreting results, and recording observations.

This is a 4 day/10 hour shift position Wednesday- Saturday

Responsibilities:

  • This role will work with vendors and/or clients (e.g., to obtain documents required for testing or instrument maintenance3).
  • Perform basic tests and analysis; conduct laboratory procedures in compliance with established protocols under supervision.
  • Test chemical components or products as assigned. This role involves the use and maintenance of major laboratory instruments and equipment (e.g., HPLC, UPLC, FTIR, HIAC, PLM, Nasal spray test equipment, as well as wet chemical skills)
  • This role will use the company’s quality systems (e.g., Documentum, Trackwise, LIMs, LN)
  • Tests chemical components or products using major laboratory instruments such as HPLC, GC, FTIR, UV-VIS spectrophotometer, pH meter, viscometer, etc.
  • Understand and execute protocols and provide information to draft in-house test standards and methods.
  • This role may assist with evaluating vendor, compendial and third-party test methods for ability to perform in-house.
  • This role may be asked to transcribe methods into in-house format and introduce them into the company’s systems.
  • This role may be asked to draft protocols, SOPs or methods.
  • This role may assist in developing test methods and in product/formulation troubleshooting issues.
  • Completing projects’ data review within time limits, and verifying mathematical calculations, interpreting results, recording observations.
  • Assist with investigations and particle identification.
  • Represent area of responsibility in internal meetings.
  • Assist with client tours.
  • Within area responsibility, understand and comply with all the company’s safety, environmental and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs, as well as applicable federal, state and local regulations
  • Accurately review data using validated test methods and SOPs in a cGMP environment

Qualifications:

  • Bachelor of Science Degree in Chemistry, Biology or related science required.
  • 2-5 years’ experience in cGMP laboratory.

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