What type of employment is offered for this Senior Manufacturing Associate, Downstream - 1st Shift role?

Full-time or part-time position

Senior Manufacturing Associate, Downstream - 1st Shift at ZYLIDAC BIO LLC | Jobs and Employment

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).

Requirements:

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.

Senior Manufacturing Associate, Downstream - 1st Shift at ZYLIDAC BIO LLC – Emeryville, California

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