Asst Manager/Manager-Analytical-PDTS

Job ID 19-00082

Industry Pharma

Job Type Permanent

Location Dayton, NJ



  • Involve in complete life cycle of Laboratory Information and Management Software (LIMS) implementation, and day-to-day support
  • Perform assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemicals, physical and instrumental techniques (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, KF Autotitrator, Bulk Density, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs.
  • Independently plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work.
  • Independently plan and execute testing to meet established time lines. Perform complicated testing with supervisory direction.
  • Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately.
  • Prepare and/or Review Test Procedures, SOPs, and Protocols as assigned.
  • Prepare the Method Transfer/Method verification protocols. Execution of the method transfer/validation/verification activities and reports preparation. Handle the ANDA and Site transfer projects independently and timely support for Regulatory filings.
  • Perform the testing activity of all Exhibit batch's required raw materials (Active/inactive/Packaging materials), finished product dosage forms and stability sample testing.
  • Provide the necessary document to Support for the ANDA filing.
  • Perform maintenance/minor repairs and calibrations on laboratory instruments/equipment with supervisory direction/training.
  • Perform troubleshooting and investigations under the direction of a supervisor/senior QC chemist.
  • Comply with all regulatory/in-house requirements (may include but not limited to safety, house keeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity.



BS or MS in Chemistry, Pharmaceutical Sciences, or related field is preferable
-Minimum 8-15 years of experience in pharmaceuticals and must have 8 + years of experience in Analytical testing
-8+ years QC experience in Generic Pharmaceutical industries would be preferable
-Experience in a cGMP environment and ANDA filing, Method Transfer/Method verifications/Validations and Deal with the CRO's is required