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Scientist/Chemist

Scientist/Chemist



Position also available in the NJ area



Responsibilities:



  • Involved in multiple, on-going projects.

  • Perform analysis in a GXP environment and may include material qualification (excipients or active pharmaceutical ingredients), release testing, and analysis required to support manufacturing functions (engineering, exhibit batches, etc), as well as on-going stability studies.

  • Perform testing using analytical equipment (i.e. UPLC, HPLC, GC, Karl Fischer, pH, UV-Vis, IR, microscopy, optical rotation) as well as using traditional wet chemistry methods (i.e. titration, TLC, sulfated ash, etc.)

  • Enter experimental information into hard-bound and electronic lab notebooks (i.e. Biovia eLN) and process analytical data accordingly (i.e. Empower 3, Excel, etc).

  • Perform additional data entry, processing, and review within LIMS system (i.e. Thermo LIMS).

  • Coordinate with team members to ensure seamless analytical coverage during manufacturing campaigns and on-going stability studies.

  • Support new project activities, as needed.

  • Perform analytical method feasibility, development and validation, as necessary.

  • Coordinate with team members to verify each other's data by reviewing eLN and LIMS entries in a timely manner.

  • Take personal responsibility to meet analytical testing and data verification deadlines, as well as safety and training requirements.

  • Author protocols, reports, or other technical documents, and presents project data to group, as needed.

  • Primary interaction will be with PharmSci R&D group and will also work with other product development groups including GTS and Center One.

  • Work with Chemistry Quality group and Manufacturing.

  • Possible interaction with CROs.


Scientist/Chemist


Scientist/Chemist



W2 ONLY!!! NO CORP TO CORP



Qualifications:



  • BS and 3-7 years' experience in a regulated industry (i.e. food, pharmaceutical, biotech, petroleum, etc).

  • MS and 2-5 years' experience in regulated industry.

  • PhD and 1-5 experience in regulated industry.

  • Hands-on experience with complex analytical equipment including IR, UV-Vis, imaging systems, chromatography systems (UPLC, HPLC, GC) and chromatography methods (RP, IC, SEC, etc).

  • Experience using simple analytical tools including KF titration, microscope, polarimeter, pH, analytical balances, density meter, osmometer, and etc. required.

  • Experience with simple and/or complex analytical method verification, development, transfer, or validation strongly preferred.

  • Experience working in a regulated (i.e. FDA, TTB, etc) or GMP environment is strongly preferred.

  • Understanding of various scientific software or software used in pharmaceutical or production environment (i.e. eLN, LIMS, Empower 3, Trackwise, MiniTab, Fusion, etc) would be preferred.


Scientist/Chemist



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