Title Scientist
Categories Career
Job Summary

For a contract development and manufacturing organization (Frontida BioPharm, Inc. – Philadelphia, PA): perform analytical testing to pharmaceutical manufacturing.

 

 

Responsibilities

Analytical testing, including assays, rate of release, moisture content, identification and various wet chemistry-based measurements; conduct chemical and physical testing of finished products, raw materials, Active Pharmaceutical Ingredient (API), in-process products and stability samples; conduct analytical method development, transfer and validation; design and conduct formulation and process development studies; draft and review technical documents including protocols and reports, SOPs, laboratory investigations and other documents  for regulatory submission; handle hazardous waste; perform all work in compliance with GMP, SOPs and all applicable regulatory requirements.

Qualifications
  1. Master of Science or foreign equivalent degree in Pharmaceutical Manufacturing, Chemical Engineering or a related field.

 

  1. 1 year experience in job offered or 1 year experience in regulated pharmaceutical industry. This required experience must include 6 months experience in the formulation development and processing optimization of oral solid dosage form product (IE and ER tablets), using the high/low shear granulator, roller compactor, fluid bed and tablet compressor, and 6 months experience of analysis in pharmaceutical finished products and API, developing and validating analytical method under GMP environment, resolving laboratory investigating deviations, OOS (Out of Specification) and OOT (Out of Trend). Experience can be gained while pursuing degree.

 

  1. Proficiency in HPLC/UPLC, GC, Dissolution Apparatus, Karl Fisher, FTIR, Ultraviolet-visible (UV) Spectrophotometer and the use of Empower and Chemstation software.
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