Asst Manager/Manager-Analytical-PDTS


Job ID 19-00082

Industry Pharma

Job Type Permanent

Location Dayton, NJ

Description

Description

  • 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.


Qualifications

QUALIFICATIONS:

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