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.
Who You Are:
You have a bachelor's degree in science, or related 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.
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.
Knowledge, Skills & Abilities
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. And, you must be able to travel for training.
Relocation Assistance is not available for this opportunity.
The expected salary range for this position is based on the primary location of Oregon is $44,700 and $82,900 hiring range. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. 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.
Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status.