Main Purpose of the Position:
This position is part of Genentech’s Pharma Technical – Hillsboro Individualized Therapies (HIT) team working on the individualized NeoAntigen Specific Therapy (iNeST) platform based in Hillsboro, Oregon. iNeST is a next generation immunotherapy for the treatment of patients with cancer manufactured on a per patient basis.
As a member of the HIT Manufacturing team, you will be supporting the start-up of a manufacturing facility capable of high throughput of specific patient treatments. You will help establish processes that will enable the manufacturing organization to operate successfully. This role provides the opportunity to closely partner with the Genentech iNeST PT-Development group and HIT Manufacturing Science and Technology teams as you work on start-up activities like establishing procedures, equipment qualification, process engineering and validation runs in support of an investigational clinical product.
The Technical Manager will act as an agent for associated HIT Manufacturing Manager to support the timely execution and completion of department goals. In this role, you will support the Manager/Director and the Leadership Team to drive business processes improvements that significantly enhance customer satisfaction, quality, process capability, reliability, safety, efficiency and work.
- Accountable for managing operational start-up activities (process readiness, documents, mock runs, equipment set up).
- Develop and/or improve departmental capabilities in response to corporate needs, industry practices, and regulatory agency expectations.
- Provide coordination and issue resolution across HIT Manufacturing Operations, other groups and/or projects.
- Manage the development and implementation of novel approaches to solving complex operational problems while maintaining required levels of safety, quality (including regulatory compliance), and production.
- Provide support on projects related to operations.
- Perform critical, technical and operational review and approval of documentation related to the design, validation, operation and maintenance of HIT manufacturing processes, equipment and facilities (including engineering changes, document changes, validation documentation, etc.).
- Work with MSAT and QA to resolve investigational issues. Support resolution of discrepancies particularly as related to operational and process issues (CAPAs/ Quality Excursions).
Qualifications / Requirements:
- Minimum of 5 years of relevant bio/pharmaceutical experience including significant functional group management.
- 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 ATMP’s for individualized therapies (autologous, cell, gene).
- Previous experience with individualized therapies is a plus
- A BS/BA degree in life sciences, physical sciences, engineering or an equivalent combination of education and work experience is required.