Manufacturing Associate, Downstream

Asahi Kasei • Fremont, CA

3d • $25 - $30

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

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: Associate degree
• Number of Employees: 5,001-10,000 employees