Manufacturing Associate, DS
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, facility buildout, 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 readiness and manufacturing activities. The scope of responsibilities may include but are not limited to Document writing (SOPs, Equipment URSs, etc.), equipment validation execution support and single-use assembly design.
Requirements
- Associate, BS, MS Biology, Chemistry or related to Life Sciences discipline with 0-3 years of relevant experience, or combination of experience and relevant advanced degree, preferably in biopharma manufacturing role.
- In-depth understanding of protein chemistry and industry-standard purification processes (affinity, IEX, SEC, viral inactivation and filtration, depth filtration, TFF, UFDF, etc) and equipment (GE AKTAs, disposables)
- Hands-on experience in running, developing, and validating processes.
- Working knowledge of cGMP compliance as it pertains to procedures, processes, and manufacturing
- Experience with process monitoring software and equipment software (UNICORN, Pi Historian)
- Demonstrate ability to work independently and on cross-functional teams
- Ability to prioritize assignments and to manage multiple projects simultaneously.
Nice To Haves
- Experience in process development, process characterization and/or tech. transfer processes.
- Creative thinker that can identify better and more efficient methods to address issues and gaps
Responsibilities
- Executes, with oversight of qualified staff, complex unit operations including but not limited to chromatography, TFF, depth filtration and virus filtration.
- Maintains own training within compliance and trains other associates on protein purification in GMP environment upon completion of trainer qualification.
- 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, experimental plans, 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 any affiliated documentation and take appropriate corrective action within scope.
- Notify supervisors and leads of issues and discrepancies immediately.
- Assess impact of issues and non-conformities to products and projects as they pertain to product safety and efficacy or project milestones.
- Evaluate new technologies and innovations to improve operational efficiency or expand purification capabilities
- Contributes to quality activities such as investigations and area walk-throughs and support authoring deviations, CAPA, change control.
- Present during inspections from regulatory agencies and client audits
Benefits
- Bionova offers health benefits at a subsidized rate. 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
