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Manufacturing Associate II

IDRI


Location:
Seattle, Washington 98102
Date:
01/22/2018
2018-01-222018-02-21
Job Code:
167970694
Job Type:
Employee
Job Status:
Full Time
Shift:
1st Shift
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Job Details

The Infectious Disease Research Institute (IDRI) is a Seattle-based non-profit research organization committed to developing products to prevent, detect and treat infectious diseases. IDRI translates basic research to develop vaccines, diagnostics and drugs for applications in global health. We focus on antigen discovery and development, adjuvant formulation and delivery, therapeutic molecule discovery and development, and biomarker discovery for diagnostics. IDRI’s leadership in the global health community extends to international alliances and partnerships with pharmaceutical and biotechnology companies, universities, research institutes, governments, and public health organizations.

 

The Manufacturing team is looking for a Manufacturing Associate to help with IDRI's growing GMP manufacturing needs.

Responsibilities:

  • Formulation and fill/finish of vaccine adjuvants for clinical trials.

  • Manage inventory for cGMP manufacturing including ordering and vendor management.

  • Shipping and receiving of GMP/clinical materials.

  • Maintenance of cGMP manufacturing facility, including cleaning of equipment and manufacturing cleanrooms.

  • Write and/or revise cGMP documents related to 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.

Requirements

  • BA/BS or equivalent in a biological science, chemistry, or 5 years’ experience in cGMP 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.

  • Experience with shipping of GMP products and shipping regulations 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.

     

     

IDRI offers a comprehensive compensation plan which includes Medical, Dental, Vision, Life, AD&D and EAP. In addition, IDRI offers Flexible Spending Accounts, a matching ROTH 401K Retirement Plan and Commuter benefits.

 

This summary describes a portion of the essential functions/responsibilities of this position. It is not an exhaustive list of all job duties. Management reserves the right to modify the duties of this position as necessary.

 

Infectious Disease Research Institute (IDRI) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status.

 

IDRI is an E-Verify Employer

 

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