Manufacturing Associate, Downstream
About The Position
The Manufacturing Associate will actively contribute to the manufacturing and technology transfer projects at the Bionova Scientific Fremont location. As part of the Purification/Manufacturing group, you will have opportunities to work on a wide-ranging set of projects for troubleshooting and investigations, system and workflow implementation, and tech transfers of processes into the GMP manufacturing facility. The role will provide hands-on execution of complex experiments in a team setting. The role will support GMP and manufacturing activities.
Requirements
- Associate degree with 1-2 years of relevant experience, or combination of experience or relevant advanced degree, preferably in biopharma manufacturing role.
- Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing, preferrable
- Working knowledge of industry-standard purification processes (affinity, IEX, SEC, viral inactivation and filtration, depth filtration, TFF, UFDF, etc) and equipment (GE AKTAs, disposables), preferrable
- Experience with process monitoring software and equipment software (UNICORN, Pi Historian)
- Creative thinker that can identify better and more efficient methods to address issues and gaps
- Demonstrate ability to work independently and on cross-functional teams
- Ability to prioritize assignments and to manage multiple projects simultaneously.
Responsibilities
- Execute, with oversight of qualified staff, complex unit operations including but not limited to chromatography, TFF, depth filtration, virus filtration, and buffer preparation in GMP manufacturing suites.
- Maintain own training within compliance.
- Support in equipment troubleshooting, pilot scale material generation, non-GMP tox material generation and GMP downstream manufacturing activities.
- Author/review/approve technical documents such as tech transfer protocols and reports, production batch records, training materials, manufacturing SOPs, and regulatory filing documents per project needs.
- Documents work according to cGMP and cGDP.
- Adheres to established regulations and follows cGMP established by site.
- Maintain cleanroom standards, practices, and housekeeping according to SOPs.
- Recognize any minor issues from the equipment and notify leads/managers of issues and discrepancies immediately.
- Contributes to quality activities such as investigations and area walk-throughs and support authoring deviations, CAPA, change control.
- Other duties as assigned and flexible to work in shifts
Benefits
- Healthcare, Dental, and Vision insurance
- Life Insurance and Disability Program: 100% covered by Bionova.
- Retirement Plan (401K) Up to 8% of Employer Match
- Paid time off up to two weeks
- 10 days of Holidays and 5 days of Sick Leave.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
Associate degree
Number of Employees
5,001-10,000 employees
