Cell and Gene Therapy Manufacturing Manager/Senior Manager

This position is part of Genentech's Pharma Technical - Hillsboro Innovative Therapies (HIT) team working on the cell and gene therapy platforms based in Hillsboro, Oregon. As a member of the HIT Manufacturing team, you will be supporting the start-up and operation of a manufacturing facility capable of high throughput of various patient treatment modalities. You will be accountable for the successful execution of clinical manufacturing and support the site's technology transfer projects by establishing processes that will enable successful HIT Manufacturing operations and clinical supply to patients.

The Opportunity:

As a Manufacturing Manager/Senior Manufacturing Manager, you will closely partner with the Genentech PT-Development group and HIT Manufacturing Science and Technology teams. You will be responsible for planning and managing activities related to the production of clinical manufacturing, authoring, reviewing, and approving procedures, executing equipment qualifications, supporting process engineering, and performing validation runs for investigational clinical products. Additionally, you will:

• Provide leadership and professional development to Manufacturing Engineers and Immunotherapy Specialists to build high-performing teams

• Create a culture of learning and safety through discussions, timely coaching, and incident reviews

• Develop and foster cross-functional relationships with Quality, Materials Management, ADT, and MSAT to ensure compliant manufacturing processes

• Serve as an escalation point for manufacturing issues, working with MSAT and QA to resolve operational and process discrepancies (including CAPAs and quality excursions)

• Manage operational start-up activities, technology transfer project deliverables, and ensure execution according to cGMPs, batch records, SOPs, and work instructions

• Implement continuous improvement practices and participate in CAPAs and change control activities

• Oversee the training and professional development of team members, including operator training qualifications and performance evaluations

Who You Are: Note that this position can be hired as either a Manager or Senior Manager, depending on candidate qualifications.

Manufacturing Manager

• You possess a Bachelor's degree in life sciences, physical sciences, engineering or related discipline

• You have at least 8 years of relevant bio/pharmaceutical experience including significant people leadership experience

• You possess a fundamental, working knowledge of safety, Business/Quality systems, and quality assurance concepts is required including the application of current Good Manufacturing Practices (cGMPs) and ATMPs for individualized therapies (autologous, cell, gene)

The expected salary range for this position based on the primary location of Oregon is $98,800 - $141,200. 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

Senior Manufacturing Manager

• You possess a Bachelor's degree in life sciences, physical sciences, engineering or related discipline

• You have at least 12 years of relevant bio/pharmaceutical experience including significant people leadership experience

• You possess a fundamental, working knowledge of safety, Business/Quality systems, and quality assurance concepts is required including the application of current Good Manufacturing Practices (cGMPs) and ATMPs for individualized therapies (autologous, cell, gene)

The expected salary range for this position based on the primary location of Oregon is $126,400 - $234,800. 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

Relocation is approved for this position.

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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.