Scientist I- Analytical R&D Specialist

2 days ago


Lakewood, New Jersey, United States Renaissance LLC Full time
Job Title: Scientist I- Analytical R&DCompany: Renaissance LLC

Renaissance LLC is seeking a highly skilled Scientist I- Analytical R&D to support validation activities of analytical methods and method transfer from R&D to QC labs for new pharmaceutical projects.

Job Summary:

The purpose of this role is to apply a working knowledge of method validation theories, practices, and concepts while working under the direct supervision of senior R&D scientists to execute validation activities. This role will ensure standard operating procedures and protocols are maintained and applied.

Responsibilities:
  • Support validation activities of analytical methods and method transfer from R&D to QC laboratories as per the current SOPs, ICH, and FDA guidelines.
  • Conduct routine and non-routine laboratory analyses such as finished product testing, stability testing, and manufacturing in-process testing of R&D/engineering batches.
  • Use analytical techniques like HPLC/UPLC, GC using empower software, Karl Fisher, UV spectrophotometer, etc.
  • Author standard methods of analysis and review analytical test methods, reports, and protocols.
  • Operate all laboratory analytical instrumentation and perform troubleshooting and calibrations of laboratory equipment as needed.
  • Manage time effectively to complete assignments in an expected timeframe.
  • Document all experimental work neatly and correctly in a lab notebook in accordance with SOPs.
  • Ensure proper training before performing any tests and maintain an up-to-date training record related to all job functions and GXP requirements.
  • Maintain quality checks on safety of the lab, including biohazards, and ensure maintenance of the facilities according to GLP.
  • Comply data and interpret any out of trend/specification against predetermined validation criteria and update R&D Management accordingly.
  • Effectively interact with other scientists, project managers, and colleagues from numerous functions.
Qualifications:

Bachelor's of Science Degree in Biochemistry or Chemistry

1-5 years of analytical laboratory experience in Pharmaceutical industry

Experience with method validation is required and method development is preferred.

Compensation details: 71300-85800 Yearly Salary


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