Immunotherapy Specialist I (Contractor)

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 I (Contractor) will be supporting the establishment of a manufacturing facility producing a variety of patient and non-patient

specific treatments including cell and gene therapies. Immunotherapy Specialist I (Contractor) will follow processes that will enable the manufacturing organization to operate successfully. This role

provides the opportunity to closely partner with the Genentech PT-Development group, Quality

Assurance, Analytical Development and Testing, and HIT Manufacturing Science and

Technology teams as they work on start-up activities.

In this role, you will be an employee of Magnit, working on a Genentech contract.

Shift: M-F 8am-5pm. Working days and shifts outside of this time (including weekends and holidays) will occasionally be required.

12-month contract (possible extensions up to 36 months with potential to convertto regular employment)

Pay rate: $25/hour to $31/hour (Depends on Experience)

Activities include the following procedures (SOPs, batch records) and performance

engineering/validation manufacturing runs in support of investigational clinical products. HIT will

also produce commercial products once established.

Responsibilities:

In this role, the Immunotherapy Specialist I (Contractor) will have the opportunity to perform Engineering and GMP clinical/commercial manufacturing of novel therapies. Immunotherapy Specialist I (Contractor) 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.
• Maintain and clean manufacturing equipment.
• Participate in the Planned/Unplanned Event processes to identify and remediate issues.
• Adhere to all plant safety policies and procedures and proactively identify unsafe conditions.
• Complete training to support operations (gowning, aseptic techniques, process).
• Conduct environmental monitoring activities in the manufacturing areas as required.
• Support production by performing day-to-day decision making.
• Requires frequent supervision and instructions for routine work and detailed instructions given for new activities or special assignments.
• Has a compliant understanding of GMP documentation requirements.
• Performs basic SAP/LIMS transactions.

Qualifications/Requirements:

A.S. degree in a science and 0-3 years of experience or an equivalent combination of

education and experience.

• Previous experience with cell and/or gene therapies is a plus.
• Proficiency in reading, writing, and communication in the English language.
• All candidates must pass a vision acuity and color discrimination test.
• Must complete initial and periodic physical examinations to identify medical conditions which pose a risk to cleanroom operations.
• Must be computer literate, including ability to interface with computer systems (SAP, MES) and use Microsoft and Google products.
• Must be able to travel for training.
• Knowledge of Health Authority (FDA, EMA, etc.) requirements and other regulatory agencies related to cleanroom operations is a plus.
• Explain/demonstrate production tasks to other employees.
• Shifts are typically 8 hours on Mon-Fri, but overtime and altered schedules will sometimes be required to support operations. These can include weekends, evenings, and nights.
• Contract is one year with potential to extend.

Genentech is an equal opportunity employer. It is our policy and practice to employ, promote, and otherwise treat any and all employees and applicants on the basis of merit, qualifications, and competence. The company's policy prohibits unlawful discrimination, including but not limited to, discrimination on the basis of Protected Veteran status, individuals with disabilities status, and consistent with all federal, state, or local laws.

If you have a disability and need an accommodation in relation to the online application process, please contact us by completing this form Accommodations for Applicants.