Immunotherapy Specialist I

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 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 I 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 Quality Control, and HIT Manufacturing Science and Technology teams as they work on start-up activities.

Activities include following procedures (SOPs, batch records) and performing engineering/validation manufacturing runs in support of investigational clinical products. HIT will also produce commercial products once established.
 

Your Opportunity:

In this role, the Immunotherapy Specialist I will have the opportunity to perform Engineering and GMP clinical/commercial manufacturing of novel therapies. The Immunotherapy Specialist I 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.

• Required to work nights / weekends as necessary

Who You Are: 

• You have an A.S. degree in a science or engineering field and 0-2 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.

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*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 $43,300.00 - $70,800.00 annually.  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.

Benefits

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.