Chemist A

Job Overview:
The Chemist will perform a variety of testing to assess the strength, identity and purity of finished product, which are mainly oral solids and/or raw materials. The Chemist will work as a member of the Analytical R&D team to effectively plan and develop/validate new methods (for Assay, Dissolution, Residual solvents, and Related compounds tests) to execute analytical testing and/or test using established (official and/or in-house) test procedures. The Chemist may execute 90% - 100% of their work at the bench level.

Responsibilities
Hands on experience to Perform/develop assigned physical and chemical tests on raw materials and active pharmaceutical ingredients using various wet chemicals, physical and instrumental techniques (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, KF Auto titrator, Bulk Density, and other routine instruments).
Able to perform/develop assay, related compounds and dissolution testing on in-process, finished product and stability samples using various wet chemicals, physical and instrumental techniques (HPLC/UPLC, Dissolution, GC, UV-Vis, and other routine instruments).
Perform analytical method validation for various tests including but not limited to assay, related compounds, dissolution, residual solvents and particle size by Malvern.
Independently plan and execute testing to meet established timelines.
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, Validation Protocols/Reports as assigned.
Perform maintenance and calibrations of laboratory instruments/equipment with supervisory direction/training.
Perform troubleshooting and investigations under the direction of a supervisor.
Comply with all regulatory/in-house requirements (may include but not limited to safety, housekeeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing tassigned activities.
Review and prepare technical documents as required.

Qualifications - Skills & Requirements
Minimum BS/MS in a Scientific field.
Minimum 1-3 years experience in pharmaceuticals in R&D and 2-4 years in QC setting.R&D/QC experience in the Generic Pharmaceutical industry, however R&D experience would be preferable
Experience handling controlled substances within DEA requirements is preferable.
Knowledge in Good Documentation practices. Knowledge in USP/ICH/FDA/DEA regulations preferable.
Ability to learn quickly and decision-making skills.
Good time management skills are required.
Must be able to work in the US without requiring sponsorship

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