Pilot Plant Associate
South San Francisco, CA 94080 US
Job Description
The Role
Reporting to the Pilot Plant Manager, the Pilot Plant Associate will participate in upstream and downstream areas of AAV development in the Pilot Plant for new gene therapy programs and processes.
Responsibilities
- Perform all operations as directed per internal policies and other requirements.
- Perform legible, clear, and concise data entry into batch records, logbooks, and all other ancillary controlled forms used in the process
- Maintain a high level of attention to detail with regards to all aspects of manufacturing execution
- Operate production equipment, including inspection, set up, processing, and cleaning
- Execute corrective measures addressing any issues in a timely manner
- Attend safety meetings and follow all safety procedures as defined, including maintaining a safe work environment for both self and colleagues. Execute corrective measures addressing any issues in a timely manner
- Ability to contribute to process improvement plans and help drive to completion
- Conduct operations in a collaborative, team environment with a positive attitude to accomplish goals
- Available to work outside of normal business hours and/or overtime as required
- Assist with process development experiments following defined experimental plans for non-GMP supply
- Assist in the evaluation and incorporation of new technologies
- Other duties as assigned
Required Qualifications
- BS in Science or Engineering or equivalent experience
- Associate I: 0-1 years of experience working in a pharmaceutical/biologics manufacturing environment
- Display understanding of upstream and downstream process theory (i.e., Fermentation, Harvest, Tangential Flow Filtration, Column Chromatography) and equipment operation
- Strong communicator with ability to work effectively both independently and as part of a team
- Demonstrated experience in maintaining detailed records and ability to assist in document revisions
- Strong computer skills including MS Office (Word, Excel, PowerPoint)
- Effective problem-solving skills
- Available to work outside of normal business hours and/or overtime as required
- Models our Core Values: Be Bold, Care Deeply, #GetStuffDone - is experienced as someone who exemplifies
the culture we want to create; operates with transparency; is trusted
Preferred Qualifications
- Experience in cell culture and/or protein purification
- Experienced in Startup of a new facility
- Technical understanding of a biotech manufacturing facility
- Experience with single-use technologies
- Working knowledge of disposable manufacturing methodology such as the use of sterile bags with tubing and tubing welders
- Ability to multi-task, be flexible and to thrive in a fast-paced environment, as well as the capacity to handle uncertainty and changing priorities
All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.
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