Biomanufacturing Assistant
Summary
Responsible for performing the day-to-day activities that support the biomanufacturing and assembly of clinical and commercial tissue products. Responsibilities primarily include cleaning and maintenance of the manufacturing areas and equipment as well as stocking and staging of supplies. The role also includes aseptic operations such as tissue maintenance and media supplementation while adhering to standard operating procedures and batch record instructions
Essential Functions
Perform scheduled cleanings and/or maintenance of production areas and equipment as necessary.
Stock, stage, and relocating materials as necessary.
Operate and maintain basic cell culture equipment such biological safety cabinets (BSC), incubators, centrifuges, media pumps, balances, etc.
Maintain appropriate inventory levels of all materials and supplies in the manufacturing suites needed to support the production process.
Perform aseptic biomanufacturing tasks such as media supplementation and tissue maintenance processes per standard operating procedures and batch production documents while in a cleanroom environment.
Perform required dynamic environmental monitoring, as needed, in support of the production process.
Weigh, measure and verify process materials to ensure batches manufactured contain proper ingredients and quantities.
Accurate documentation and compliance with cGMP.
Work with senior team members to compose and complete deviations and/or other quality documentation in a timely manner.
Ability to work scheduled shifts, holidays and/or off-shift duties, as necessary.
May perform additional duties as required.
Minimum Requirements
Education / Experience / Skills:
Associates Degree OR B.S./B.A. in life sciences or related discipline. preferred not required.
Experience in GMP production setting preferred
Competencies:
Ability to meticulously adhere to written procedures.
Ability to operate in a cleanroom environment wearing special garments.