Cell and Gene Therapy Manufacturing Manager/Senior Manager

Genentech-posted 3 months ago
$98,800 - $141,200/Yr
Full-time • Manager
Hillsboro, OR
Chemical Manufacturing
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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.

  • Plan and manage activities related to the production of clinical manufacturing.
  • Author, review, and approve procedures.
  • Execute equipment qualifications.
  • Support process engineering and perform validation runs for investigational clinical products.
  • Provide servant style leadership and support 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 utilizing active listening skills.
  • Develop and foster cross-functional relationships with Quality, Materials Management, ADQC, 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 leveraging lean manufacturing tools and participate in CAPAs and change control activities.
  • Oversee the training and professional development of team members, including operator training qualifications and performance evaluations.
  • Bachelor's degree in life sciences, physical sciences, engineering or related discipline.
  • For Manufacturing Manager: At least 8 years of relevant bio/pharmaceutical experience including significant people leadership experience.
  • For Senior Manufacturing Manager: At least 12 years of relevant bio/pharmaceutical experience including significant people leadership experience.
  • Fundamental, working knowledge of safety, Business/Quality systems, and quality assurance concepts including the application of current Good Manufacturing Practices (cGMPs) and ATMPs for individualized therapies (autologous, cell, gene).
  • Discretionary annual bonus based on individual and Company performance.
  • Relocation assistance.
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