Senior Immunotherapy Specialist

Roche • Hillsboro, OR

1d • 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 Senior Immunotherapy Specialist 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 Senior Immunotherapy Specialist 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.

Requirements

• BS/BA degree in science and 3-5 years of experience, or an equivalent combination of education and experience.
• Compliant understanding of GMP documentation requirements and can develop improvements and recommendations.
• Ability to explain/demonstrate production tasks to other employees.
• Ability to perform basic and advanced SAP/LIMS transactions and can resolve errors.
• Proficient in reading, writing, and communication in the English language.
• Computer literate, and have the ability to interface with computer systems (SAP, MES) and use Microsoft and Google products.
• Ability to complete periodic physical examinations to identify medical conditions which pose a risk to cleanroom operations.
• Ability to work all shifts (1st, 2nd, or 3rd, weekends, holidays, 12 or 10 hours), required overtime as needed and stand for extended periods.
• Ability to travel for training.
• Must pass a vision acuity and color discrimination test.

Nice To Haves

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

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.
• Maintain and clean 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.
• Act 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.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• This position also qualifies for the benefits detailed at the link provided below.

What This Job Offers

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