Process Development Scientist

Sunrise System Inc
Published
July 29, 2022
Location
Houston, TX
Category
Job Type

Description

Sunrise System Inc. is currently looking for Process Development Scientist in Houston, TX with one of our top clients.

Job Title: Process Development Scientist
Job Id : 22-08776
Location : Houston, TX 77047
Duration: 9 months
Position Type : Hourly contract Position (W2 only)

NOTE : Company policy requires newly hired employees to be fully vaccinated for COVID-19 as of their start date. Company is an equal opportunity employer and will provide reasonable accommodation to the unvaccinated in accordance with federal, state, and local law.

Summary

  • The MSAT Scientist (Drug Product) will be responsible for the successful transfer of drug
  • product filling, inspection, labeling, and packaging processes into GMP production. The
  • incumbent will collaborate with cross-functional teams, including Client’ s, Process
  • Development, Manufacturing, Quality Assurance and Program Management to ensure GMP
  • readiness
  • MSAT Scientist (Drug Product) will act as a technical Subject Matter Expert (SME) within the MSAT group as well as for the various project teams. The incumbent will provide technical support to General Manufacturing Practices (GMP) execution of the new processes and any deviation investigations, Corrective Action Prevention Plans (CAPAs), and necessary change controls. MSAT Scientists III ensure process scalability and manufacturability
  • Client-facing functional Lead for Process Technology Transfers. Performance detailed review of clients and Process Development process and generates technology transfer documents. Performs process monitoring (manufacturing data analysis, summary, and presentation), author campaign summary reports. Recommends improvements for MSAT practices and procedures
  • Supports root cause analysis for major process deviations. Support CAPA and change control processes
  • Management of data and analyzes of various operational parameters
  • Technology transfer activities. The activities include but are not limited to, performing process fit-to-plant, equipment characterization and scale-up, process Failure Modes and Effects Analysis (FMEA)-based risk assessment, creation of Process Flow Diagrams and Bill of Materials, review and approval of production Master Batch Records.
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