Drug Supply Chain Manager

Location: Morris Plains, New Jersey, United States
Salary: competitive
Job Type: Contract
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Title: Drug Supply Chain Manager

Contract Length: 6 Months

Location: Morris Plains, NJ

Job Duties/Responsibilities

  • Understanding and experience of cGMP Clinical and Commercial drug supply chains and operations
  • Manage internal review and approval of clinical and commercial labels and packaging records
  • Ability to work on SOPs for packaging and labelling, as well as implementing change controls in a cGMP environment
  • Manages the review of deviation investigations and resolving temperature excursions
  • Experience with Serialization / DSCA regulations for US Commercial supply would be a plus
  • Works with QA supplier to release clinical trial material and commercial material in a timely manner
  • Develops short and long-range demand and packaging plan to insure 100% drug availability for every patient visit
  • Manages international distribution and logistics for multiple clinical programs and for commercial launches/on-going supply
  • Strong understanding of GMP/GCP; industry procedures and regulations
  • Strong understanding of clinical study design, execution and drug product supply logistics
  • Knowledge on cold chain logistics management

Experience:

  • 5+ years of cold chain experience
  • 3-5 years of clinical supply or commercial supply or a combination
  • Worked with IRT system for clinical is not required, but a plus
  • Worked with EPCIS system for commercial would be a plus
  • Education - BA, BS in an engineering, or a science discipline

Sthree US is acting as an Employment Business in relation to this vacancy.

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