GMP BioManufacturing Operator I
The BioManufacturing Operator will work daily in labs performing tasks associated with GMP services. The BioManufacturing Operator is expected to become familiar with all products and to be able to perform most tasks associated with the purification of plasmid DNA.
Essential Duties and Responsibilities:
Segregation, line clearance and cleaning of GMP production areas.
Planning and submitting inventory requisitions.
Planning and preparation for production events including preparing of processing plan memos.
Coordination for production events with buffer preparation operators.
Execution of GMP projects with either upstream or downstream tasks and all special considerations associated.
Upstream tasks including: Transformation, Subculture, Cell banking, Shake flask growth and harvest, Wave growth and harvest, Fermentation, Media fill events, Final formulation, filtration and dispensing.
Downstream tasks including: Project Set up, Lysis, Anion Exchange Chromatography, and Hydrophobic Interaction Chromatography (void and enrichment), Thiophilic Absorption Chromatography, Diafiltration, and small scale processing as well as linearization.
Completion of all documentation associated with GMP projects.
Coordination and sample submission with Quality Control.
Packaging of final material prior to shipment.
Equipment calibration and preventative maintenance.
Assisting in writing Manufacturing Summary Reports after project completion.
Maintain personnel training record.
Assist with assembly and segregation of all consumables and equipment resources for GMP production runs.
Participate and support of internal audit program by providing requested information and responding to findings presented in the audit report.
Communicate the status of operations, process issues, and safety and maintenance issues to appropriate area management.
Responsible for following SOP’s and adhering to regulatory expectations.
Completion and maintenance of GMP Bill of Materials for GMP projects.
Completion of Metrics Tracking
All employees are responsible for the general upkeep of work and shared spaces.
Other duties as assigned.
4 years of related experience or has established level of proficiency and demonstrated core competency
Bachelor’s Degree in Life Sciences (Biology, Chemistry, Biotech) preferred
Skills and Knowledge:
Must possess excellent written and verbal communication skills
Apply basic math (arithmetic, ratios, proportions and conversions)
Good knowledge of computers and programs, like Microsoft Office and Smartsheet
Good organizational skills
Follow-through on methodology, understanding that bacteria are living organisms that do not adhere to a schedule.
Ability to work effectively within a team.
Ability to efficiently and accurately pipette into small vials.
Ability to shake, move, agitate, etc. glass vials and bottles.
Ability to lift and move material and equipment.
Ability to follow written procedures, and written and verbal directions.
Ability to keep records and maintain files.
Ability to self-report mistakes or concerns to their manager