- Entry level
- No Education
- Salary to negotiate
Job Description Summary
This position is part of Genentech’s’ Pharma Technical - individualized NeoAntigen Specific Therapy (iNeST) team based in Hillsboro, Oregon. iNeST is a next generation immunotherapy for the treatment of patients with cancer manufactured on a per patient basis. In this critical role, you will be part of a dedicated cross-functional team working on production start-up activities such as the design, installation, testing, and validation of equipment, processes, and the quality approach for this exciting and novel technology.
As the leader of the iNeST MSAT team, you will be supporting the design and start up of a GMP facility capable of manufacturing high throughput individualized therapies, you will help define the requirements for operational equipment and processes and will establish business processes that enable the organization to operate successfully. This role provides the opportunity to closely partner with tahe existing clinical facility, the iNeST Leadership Team, Engineering Team and Process Technical Development as you work on start-up activities for the new cGMP facility, processes and equipment. You will create and lead the MSAT team that is accountable for the process engineering, validation engineering and process automation activities at the iNEST site.
Leadership & People Management:
● Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term. Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.
● Establish strategic goals and objectives and maintain full strategic responsibility for the MSAT organization.
● As an iNEST site leadership team member, drive collaboration within site and across network activities, cross-functional planning, and decision making.
● Accountable for overall budget and financial performance of the MSAT organization.
● Proactively promote positive Safety Culture and cGMP operating principles.
● Embody PT lean leadership principles and methods while fostering a continuous improvement mindset
● Ensure Right to Operate through compliance with cGMP and regulatory requirements applicable to the department
● Validation: Own, execute and improve the validation program for equipment, processes, and cleaning, and ensure compliance with PQS and HA requirements. Represent Validation program during HA inspections.
● Process Automation: Own, integrate, maintain and improve all production automation platforms at the site, and ensure compliance with Health Authority requirements.
● Tech Transfer: Partner with global and site functions to specify, transfer, file and license new products/processes in the plant.
● Process Engineering: Establish oversight to ensure production is performed in conformance with license requirements, cGMPs, and global Health Authority expectations, and represent state of compliance during Health Authority inspections. Drive continually monitoring of process to implement continuous improvement process
● Manufacturing Support: Provide technical support to manufacturing organization that includes process and product monitoring and other readiness operational support activities
● MSAT Lab: Design and maintain an MSAT lab operation to support Make-Assess-Release activities, tech transfers, and continuous improvement of the production plant.
Bachelors Degree required (science or engineering)
Graduate or higher-level Degree is preferred
12 or more years’ work experience in the pharmaceutical or related industry
8 or more years’ people management experience
4 or more years’ relevant engineering or project management experience in the pharmaceutical industry and/or a cGMP environment
Experience with cell therapy or per patient manufacturing is preferred
Ability to travel up to 25% to support knowledge transfer and collaboration between teams in multiple locations
Extensive experience with start-up and validation of manufacturing equipment, utility and process systems, including requirements for documentation and testing
Broad expertise in the development and commercialization of complex biotherapeutics
About the company
Roche is a Swiss global health-care company that operates worldwide under two divisions: Pharmaceuticals and Diagnostics. Its holding company, Roche Holding AG, has bearer shares listed on the SIX Swiss Exchange.
The company headquarters are located in Basel and the company has many pharmaceutical and diagnostic sites around the world – including: Tucson, AZ; Pleasanton, CA; Vacaville, California, Oceanside, California, Branchburg, NJ; Indianapolis, Indiana; Florence, South Carolina; and Ponce, Puerto Rico in the US; Welwyn Garden City and Burgess Hill in the UK; Clarecastle in Ireland; Mannheim and Penzberg in Germany; Mississauga and Laval in Canada; Shanghai in China; Mumbai & Hyderabad in India; São Paulo and Rio de Janeiro, Brazil; Segrate, Milan in Italy; Johannesburg in South Africa; Karachi, Islamabad and Lahore in Pakistan. There are 26 manufacturing sites worldwide.