|Date Posted||March 10, 2021|
|Address||6603 Femrite Dr|
Biomanufacturing Technician (Madison, WI)
JR000011263 Biomanufacturing Technician (Madison, WI) (Open)
ST-Madison - USA504
Responsible for performing the day-to-day activities that support the biomanufacturing and assembly of clinical and commercial products. Will perform tasks such as cultivation of monolayer cells and/or tissue assembly processes and media supplementation while adhering to standard operating procedures and batch record instructions. Responsibilities will also include cleaning and maintenance of the manufacturing areas and equipment as well as stocking and staging of supplies necessary to support the manufacturing process.
- Complete daily biomanufacturing tasks such as cultivation of monolayer cells and/or tissue assembly processes per standard operating procedures and batch production documents.
- Perform aseptic techniques within a cleanroom environment including cell and tissue culture processes and media preparation.
- 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.
- Perform sampling of in-process materials as necessary for lot release testing performed by Quality Control.
- Operate and maintain basic cell culture equipment such biological safety cabinets (BSC), incubators, centrifuges, media pumps, balances, etc.
- Perform scheduled cleanings and/or maintenance of production areas and equipment as necessary.
- Maintain appropriate inventory levels of all materials and supplies in the manufacturing suites needed to support the production process.
- Stock, stage, and relocating materials as necessary.
- 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.
- Support off-shift equipment alarm response for department, as necessary.
- Ability to work scheduled shifts, holidays and/or off-shift duties, as necessary.
- May train other personnel on operating procedures for processes and equipment.
- May perform additional duties as required.
Education / Experience / Skills:
- Associates Degree with experience in a laboratory environment OR B.S./B.A. in life sciences or related discipline.
- Experience with mammalian cell culture and aseptic processing preferred.
- Knowledge of cGMP and quality management systems.
- Ability to meticulously adhere to written procedures.
- Ability to operate in a cleanroom environment wearing special garments.
A Biomanufacturing Technician is part of the Biomanufacturing team led by the Biomanufacturing Manager(s) and Biomanufacturing Director and reports into site and global Operations. The Biomanufacturing team works closely with other core Operation functions including Technical Operations, Materials Management and Facilities/Equipment. In addition, the Biomanufacturing team interfaces daily with Quality team members including Quality Assurance, Quality Control Analysts and Environmental Monitoring Technicians. The role of the Biomanufacturing Technician is at the site level and has limited interactions with above site or external parties to the organization.
The primary responsibility of Biomanufacturing Technicians is to perform aseptic operations in a classified cleanroom environment while wearing full coverage gowning. Time spent performing manipulations will be while seated and while reaching into a biosafety cabinet. Additional support roles also require full gowning while maintaining mobility and can include providing assistance to core operations, stocking, and/or staging of materials from a variety of environments including room temperature and refrigerated storage.