| Company: | Oregon Bioscience Association
Portland, OR |
| Job Location: |
Hillsboro, OR (Washington County) |
| Employment Type: | Full Time |
| Department: | Genentech |
Description: |
| The MSAT Technical Services, Engineer II will be responsible for the accurate transfer of a drug product manufacturing process from the sending site to the receiving site. They will be responsible for providing the appropriate information to maintain drug quality and comparability between the two sites. They will perform assigned tasks and work to achieve company goals and department objectives. They will do all of the above while conforming with cGMP regulations and Genentech standards. |
Duties: |
Job Duties/Responsibilities:
*Responsible for leading, managing, and executing Tech Transfer activities per the Roche 10 Step Process, including updating/improving Drug Product Tech Transfer business process, authoring Master Transfer Plan, creating/updating gap and risk analyses, creating & owning Change Records, and presenting to upper levels for approvals/progress updates.
*Establish forecasts for consumables and labor for each transfer; develop credit applications for tech transfer funding and manage to the approved budget.
* Act as project manager, creating transfer schedules and managing progress of milestones.
* Act as a liaison with other sites to collect and review documentation of previous lab, pilot, clinical, and commercial studies which characterize the drug product manufacturing unit operations including bulk freeze\thaw, formulation, buffer prep, vial filling, lyophilization, automated inspection and packaging.
* Act as a liaison with other sites to collect and review manufacturing data which demonstrate the nature and frequency of failure modes.
* Act as a liaison with other sites to determine parameter values where the equipment and process at the sending site and receiving site determined to be "like for like".
* Work with the sending site and other HFF personnel in a) determining the manufacturing parameters which are suitable for engineering studies and for DoE's; b) designing the engineering studies and DoE's.
* Collaborate with other departments to ensure studies are executed as designed and the results are well documented.
* Sign documents for activities as authorized and described by Genentech policies and procedures and job descriptions.
* Support the change management system.
* Prepare, review and approve relevant sections of regulatory submissions.
* Participate in the design and implementation of department and cross-functional initiatives.
* Troubleshoot and support the resolution of manufacturing issues by fostering effective interdepartmental and cross-functional partnerships.
* Apply advanced theory, technical principles, and expert judgment to address a broad range of difficult problems.
* Identify, design, and implement process and system improvements.
* Train personnel and internal customers on relevant business processes.
* Manage competing priorities.
* Perform any other tasks as requested by Management to support MSAT activities and network goals. |
Qualifications: |
Qualifications:
* B.A. or B.S. degree (preferably engineering) and a minimum of 3-5 years of project management/technical transfer experience in the pharmaceutical or biopharmaceutical industry (preferably drug product manufacturing)
* Knowledge of cGMPs or equivalent regulations
* Ability to make sound decisions about scheduling, allocation of resources, and managing priorities
* Ability to interpret and relate Quality standards for implementation and review
* Ability to communicate clearly and professionally both in writing and verbally
* Flexibility in problem solving, providing direction and work hours to meet business objectives
* Ability to interpret Genentech standards and practices for implementation and review |
