Biomanufacturing Associate I-III, Downstream Night Shift
Ology Bioservices, Inc.
- This position will assist in production related activities in the cGMP Manufacturing Core according to established procedures at the Medical Counter Measures (MCMs) Advanced Development and Manufacturing Facility in Alachua (Florida).
Essential Position Responsibilities:
- Assist with upstream related activities including cell culture at small and large scale, cell transfection, media and buffer preparation, and bioreactor and fermenter-based production.
- Assist with downstream related activities including chromatography purification, centrifugation and ultracentrifugation, ultrafiltration/ defiltration, and viral clearance.
- Assist in drafting Standard Operation Procedures, Change Controls, and Deviations.
- Properly disinfect and stage materials into production rooms before the production campaigns.
- Assist with equipment ordering, installation, qualification and routine maintenance
- Assist with drafting and reviewing Production batch records and review executed records.
- Assist in writing raw material specifications. research, source, and order material and lab wares.
- Assist with change-over cleaning in the manufacturing core and other production areas.
- Assist activities to support production campaign such as preparation of tubing assemblies, autoclaving, material request, and material transfer into production rooms.
- Adhere to safe working practices.
- Provide other assistance as needed to the Biomanufacturing Associates, Biomanufacturing Supervisors, and Managers
- All employees are expected to adhere to the Quality Management System established in the Quality Manual, Quality Policy, Standard Operating Procedures, Current Good Manufacturing Practices, and any other applicable regulations and standards to the duties within their role
- Ability to document work clearly and accurately and be detail oriented.
- Must have basic computer skills and familiar with Word and Excel.
- English reading comprehension and legible writing skills.
- Communication and organization skills in a teamwork environment.
- Experience working as a team member with shared responsibilities is desired
- Previous work experience in GMP environment is preferred.
- Self-motivated and hard working
- Must possess an A.S. in from an approved, Biotechnology program (or successful completion of required coursework for that degree pending internship or other require hands-on/work experience).
- A B.S. in Biology, Microbiology, Chemistry or similar science field or a high school diploma/GED and a minimum of two (2) years of relevant work experience may substitute for the required collegiate degrees.