Immunotherapy Specialist

Genentech • Hillsboro, OR

3d • Onsite

About The Position

This position is part of Genentech’s Pharma Technical – Hillsboro Individualized Therapies (HIT) team working on various individualized and non-individualized cell and gene therapies based in Hillsboro, Oregon.
As a member of the HIT Manufacturing team, the Immunotherapy Specialist II will be supporting the establishment of a manufacturing facility producing a variety of patient and non-patient specific treatments including cell and gene therapies. The Immunotherapy Specialist II will follow processes that will enable the manufacturing organization to operate successfully. This role provides the opportunity to closely partner with the Genentech Pharma Technical Development group, Quality Assurance, Analytical Development and Testing, and HIT Manufacturing Science and Technology teams as they work on start-up activities.
Your Opportunity:
You will follow procedures (Standard Operating Procedures (SOPs), and batch records) and help perform engineering/validation manufacturing runs in support of investigational clinical products.
You will work with a small team performing aseptic manufacturing activities within classified (Grade B/C/D) clean rooms and Grade A biosafety cabinets while following SOPs and batch records, while maintaining and cleaning manufacturing equipment.
You will identify and remediate issues through the Planned/Unplanned Event processes, while adhering to all plant safety policies/procedures and proactively identify unsafe conditions.
You will complete and perform training to support operations (gowning, aseptic techniques, processes).
You will conduct environmental monitoring activities in the manufacturing areas as required, and are capable of acting as a Subject Matter Expert by presenting tasks during Health Authority Inspections.
You will suggest decisions surrounding path forward during production and equipment issues, considering quality and proper escalation paths.

Requirements

• You have a BS/BA degree in science and 0-3 years of experience, or an equivalent combination of education and experience.
• You have a compliant understanding of GMP documentation requirements and can develop improvements and recommendations. You can explain/demonstrate production tasks to other employees.
• You can perform basic and advanced SAP/LIMS transactions and can resolve errors.
• All candidates must pass a vision acuity and color discrimination test.
• You are proficient in reading, writing, and communication in the English language. You are computer literate, and have the ability to interface with computer systems (SAP, MES) and use Microsoft and Google products.
• You can complete periodic physical examinations to identify medical conditions which pose a risk to cleanroom operations.
• You must be able to work all shifts (1st, 2nd, or 3rd, weekends, holidays, 12 or 10 hours), required overtime as needed and stand for extended periods.
• You must be able to travel for training.

Nice To Haves

• Previous experience with cell and/or gene therapies is a plus.
• Knowledge of Health Authority (FDA, EMA, etc.) requirements and other regulatory agencies related to cleanroom operations is preferred.

Responsibilities

• follow procedures (Standard Operating Procedures (SOPs), and batch records) and help perform engineering/validation manufacturing runs in support of investigational clinical products.
• work with a small team performing aseptic manufacturing activities within classified (Grade B/C/D) clean rooms and Grade A biosafety cabinets while following SOPs and batch records, while maintaining and cleaning manufacturing equipment.
• identify and remediate issues through the Planned/Unplanned Event processes, while adhering to all plant safety policies/procedures and proactively identify unsafe conditions.
• complete and perform training to support operations (gowning, aseptic techniques, processes).
• conduct environmental monitoring activities in the manufacturing areas as required, and are capable of acting as a Subject Matter Expert by presenting tasks during Health Authority Inspections.
• suggest decisions surrounding path forward during production and equipment issues, considering quality and proper escalation paths.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Number of Employees: 5,001-10,000 employees