This position is part of Genentech’s Pharma Technical – Hillsboro Individualized Therapies (HIT) team working on the individualized NeoAntigen Specific Therapy (iNeST) platform based in Hillsboro, Oregon. iNeST is a next generation immunotherapy for the treatment of patients with cancer manufactured on a per patient basis.
As a member of the HIT Manufacturing team, you will be supporting the start-up of a manufacturing facility capable of high throughput of specific patient treatments. You will help establish processes that will enable the manufacturing organization to operate successfully. This role provides the opportunity to closely partner with the Genentech iNeST PT-Development group and HIT Manufacturing Science and Technology teams as you work on start-up activities like establishing procedures, equipment qualification, process engineering and validation runs in support of an investigational clinical product.
In this role you will have the opportunity to perform the cGMP manufacture of this exciting clinical product. Working within a classified clean room environment, you will follow proper aseptic technique to execute the batch records and SOPs associated with this product. Proficiently operate and maintain manufacturing equipment according to SOPs. Other duties, such as cleaning and deviation support, will be performed as assigned.
Qualifications / Requirements:
- B.S./B.A. degree and three years of experience or GED plus five years of experience or an equivalent combination of education and experience
- Previous experience with personalized therapies (autologous, cell, gene) is a plus
- Proficiency in the English language - reading, writing, and communication
- Must be able to work all shifts (1st, 2nd, or 3rd), required overtime as needed, able to lift 45 pounds, and stand for extended periods of time
- Experience in LEAN
- In addition, all candidates must pass a vision acuity and color discrimination test
- Must complete periodic physical examinations to identify medical conditions which pose a risk to Grade C or higher operation
- Must be computer literate, including ability to interface with computer systems and PLC-based logic.
- Must be able to travel for initial training period