Scientist II, R&D

7/8/21

Tom's River, NJ

1296

FullTimeRegular

Scientist II, R&D

The Scientist II, R&D position supports validation activities of analytical methods and method transfer from R&D to QC labs for new pharmaceutical products. Applying a solid understanding of Method Validation theories, practices and concepts, the incumbent works under the general direction of more senior R&D scientists to execute method validation, and method transfer activities. Ensure Standard Operating Procedures and protocols are maintained and applied.

Technical Responsibilities:

  • Under the general direction of the R&D Manager or a Senior Scientist, support validation activities of analytical methods and method transfer from R&D to QC labs as per the current SOPs, ICH and FDA guidelines.
  • Support formulation and process development and regulatory submission activities.
  • Use analytical techniques like HPLC/UHPLC, and GC using empower software, Karl Fisher, UV spectrophotometer etc., that is used in analytical development activities.
  • Troubleshoot analytical challenges with minimum supervision.
  • Compile, maintain, review and interpret analytical data.
  • Assist with generating technical documents required for method validation and ANDA submissions such as recommendation and justification of specifications for finished products as per the current regulatory guidance.
  • Author standard method of analysis.
  • Author and review analytical test methods, reports and protocols.
  • Conduct routine and non-routine laboratory analyses such as finished product testing, stability testing, and manufacturing of R&D and Engineering batches in-process testing which require critical levels of accuracy.
  • Operate all laboratory analytical instrumentation including Empower 3 software, UPLC/HPLC, GC and UV/VIS, and other methodologies/instrumentation under minimum supervision, and perform troubleshooting and calibration of laboratory equipment as needed.
  • Evaluate method and work with method development scientist to ensure minimum method validation and transfer challenges issues.
  • Document all experimental work neatly and correctly in a lab notebook in accordance with Standard Operating Procedures.
  • Review lab testing results and notebooks of peers to ensure accurate documentation.
  • Maintain current knowledge of relevant other regulatory requirements related to method validation.
  • Maintain quality checks on safety of the Lab, including biohazards and ensure maintenance of the facilities according to Good Laboratory Practices.

Communications

  • Prepare data summary presentations, compile data and author technical and validation reports for ANDA submissions.
  • Effectively interact with other scientists, project managers and colleagues from numerous functions.

Leadership

  • May be sought out by other teams and individuals to offer technical advice.
  • Mentor junior scientists

Qualifications:

  • Bachelor’s degree in Pharmaceutical Sciences, Chemistry, or similar degree and a minimum of 2-3 years of relevant experience in the pharmaceutical industry is required.
  • Master’s degree with a minimum of 1 -2 years of experience is preferred, along with substantial experience and a proven record of achievement (Master’s degree will substitute for 2 years of experience).
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