About this position
Description:
- Assist CMC team with technical transfer activities.
- Assist in the creation of the Bill of Materials for the downstream process.
- Assist in development and creation of the downstream process.
- Monitor fermentation and purification operations (including trouble shooting and diagnosis of instruments, equipment, process, etc.).
- Set-up, prepare, and operate manufacturing equipment/labware/assemblies (includes filtration skid, chromatography skid, fermenter, autoclave/ sterilizer, bench top meters (pH/ conductivity/ osmometer/ SoloVPE) in accordance with current good manufacturing practices (cGMP).
- Record and document procedures with detail and accuracy. This includes batch records, training records, logbooks, standard operating procedures (SOPs) and validation protocols.
- Execute quality systems (including critical work orders, change requests, engineering change, deviations, corrective action preventative action (CAPA).
- Create and revise standard operating procedures, batch records, specifications, etc.
- Weigh and prepare culture media, buffers, and solutions.
- Coordination and collaboration of activities with other departments, and with vendors.
- Sample solutions and perform analytical assays (including cell counts, pH, conductivity, etc.)
- Perform technical training (including hands-on and class-based training)
- Identify and implement equipment and process improvements.
- Plant cleaning (including floors, benches, fermenters, equipment, etc.) waste disposal, lean manufacturing and compliance to good manufacturing practices (GMP).
- 2 years of college science in Cell Biology, Biochemistry, Chemistry, Biology, with 2 to 4 years of related experience.
- Or 4 to 8 years of experience and/or training, or equivalent combination of education and experience.
- Knowledge of chromatography equipment (columns, skids, flow/ UV/ pH/ conductivity/ SoloVPE/ Misc. sensors), filtration equipment, solution preparation equipment (laminar air flow hood, agitator mixers, bench top meters) are essential for this position.
- Diligence and accuracy for record keeping and documentation is mandatory in this position
- Teamwork and communication are key attributes needed for this position, as this role will be part of a small team within downstream purification. A collaborative attitude and a positive work ethic are key traits for success.
- Skills in Biological/ Chemical Sciences, Math and English.
- Knowledgeable in Microsoft applications (Outlook, Word, Excel, PowerPoint, etc.) SAP or Oracle applications.
- Knowledgeable data mining and entry
- Knowledge of cGMP’s.
- Able to work independently as part of a team or lead a team on assigned projects.
- Effective organizational and solid record-keeping skills.
- Effective communication skills.
- Ability to lift >50lbs, stand on feet for 2 hours, squat, crawl, bend and work in loud, wet, and hot/ cold environments.
- Ability to stand and manage repetitive motions for an extended amount of time.
- Ability to use vision to differentiate colors.
- Effective hearing capabilities.
- Ability to work comfortably with large equipment.
Salary Information
$35.00 - $50.00
Hourly Wage