Manufacturing Associate, Downstream
Bionova Scientific LLC Job Description: Company Summary: Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients' expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Position Summary: 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. Essential Duties and 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
- This position required to work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and or move up to 20 pounds independently.
- 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.
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