Principal Engineer-Drug Substance

Job Position: Principal Engineer-Drug Substance
Work Location: 6 Cedarbrook Drive, Cranbury, NJ 08512
Job Description:

  • Perform multi-step drug substance synthesis and API crystallization in the range from milligrams to kilograms under cGMP and FDA compliance;
  • Conduct compound impurities and chemical structure elucidation for chemical intermedia and drug substance utilizing techniques of FTIR, 1 H-NMR, LC/MS, UV-Vis, HPLC, and GC;
  • Execute pharmaceutical unit operations simulation/modeling to support characterization and process challenges in development of API;
  • Conduct pharmaceutical kinetic study to facilitate scale-up of controlled crystallization process in CSTR (Continuous Stirred Tank Reactor);
  • Evaluate and troubleshoot pharmaceutical manufacturing process in API and drug product development;
  • Perform thermodynamics properties of organic compounds for stability testing and pre-formulation analysis;
  • Participate in early drug development for high potency compounds and controlled substance;
  • Analyze and evaluate the raw data from API and drug product process development utilizing MINITAB;
  • Write/review developmental chemistry, process optimization and process scale-up reports to support FDA requirements for CMC (Chemistry, Manufacturing and Control) sections of INDs/NDAs.

Education Requirement:
MS degree in Chemistry or Chemical & Biochemical Engineering

Specific Knowledge/ Skills Requirement:
Must have knowledge and skills in chemical structure elucidation, API crystallization; pharmaceutical unit operations; thermodynamics properties; cGMP regulatory; pharmaceutical controlled substance.

Work Experience Requirement:
Six months experience in pharmaceutical development

Salary: $80,080.00 per year
Hours: Monday to Friday – 40 hours, 8:30AM to 5:30 PM
Contact: Tom Micholas, Human Resource Generalist

J-Star Research, Inc.
3001 Hadley Rd. Suites 1-5A
South Plainfield, NJ 07080

Dates of Posting: April 19, 2021 to May 5, 2021

This notice is posted in connection with the filing of an Application for Permanent Alien Labor Certification. Any person may provide documentary evidence bearing on the Application to either (or both) of the offices listed below:

U.S. Department of Labor
Employment and Training Administration
Atlanta National Processing Center
Harris Tower
233 Peachtree Street, N.E.
Suite 410
Atlanta, GA 30303

THIS NOTICE WAS POSTED IN A CONSPICUOUS PLACE AT THE OFFICE OF Inteplast Management Services, Inc. in Livingston, NJ FOR A PERIOD OF TEN CONSECUTIVE BUISNESS DAYS AS STATED ABOVE. THE NOTICE REMAINED CLEARLY VISIBLE AND UNOBSTRUCTED DURING THE ENTIRE PERIOD OF POSTING.

About

J-STAR Research, Inc. is committed to assisting employees maintain a healthy and productive lifestyle for themselves and their families. We are proud to offer our employees the following benefits:

  • Health & Prescription Drug Insurance
  • Dental Insurance
  • Vision Insurance
  • FSA
  • Commuter Benefits
  • Long-Term Disability
  • Short-Term Disability
  • Term Life
  • Retirement Savings Plan
  • Fitness Reimbursements