Manufacturing Associate / Senior Manufacturing Specialist

Employer
Infectious Disease Research Institute
Location
Seattle, Washington State
Salary
DOE
Posted
Mar 28, 2018
Ref
168004161
Required Education
Bachelors Degree
Position Type
Full time
  • Formulation and fill/finish of drug products for clinical trials.
  • Maintenance of cGMP manufacturing facility, including cleaning of equipment and manufacturing cleanrooms.
  • Write and/or revise cGMP documents related to technology transfer and production and materials management (SOP's, CAPA's, IQ/OQ/PQ's, etc.)
  • Remain on-call after hours (on rotating basis) to monitor and respond to equipment alarms as needed.
  • Participate in implementing process improvements and corrective actions.
  • Manage inventory for cGMP manufacturing including ordering and vendor management.
  • Shipping and receiving of GMP/clinical materials.

Requirements:

  • BA/BS or equivalent in a biological science, chemistry, or 5 years’ experience in cGMP drug product manufacturing environment.
  • Experience with fill and finish operations for small volume parenterals desired.
  • Ability to follow cGMP regulations and industry standards for production of sterile drug products.
  • Experience with cGMP qualifications/validations (IQ/OQ/PQ) of facilities, equipment, and manufacturing processes desired.
  • Experience with pharmaceutical inventory/supply chain management desired.
  • Must be motivated, able to follow written or verbal direction and work under minimal supervision, and willing to perform hands-on operations of production activities.