Who are we?

As an ON-SITE Upstream Manufacturing Associate I you will:

• Provide training to new personnel in a specific technical process.
• Maintain records to comply with regulatory requirements and performs daily in-process testing.
• Propose implementation of production procedures to optimize manufacturing processes. Monitor processes and results and suggest methods to ensure process success.
• Maintain daily workload schedule and relevant resource requirements.
• Draft, execute, document, and review data, and approval of SOP's and batch records according to GMP guidelines.
• Assist in audits from internal or external partners.
• Initiate deviations, assess product quality impact, and propose and execute Corrective and Preventative Actions (CAPA).
• Act as the Change Owner for implementation or revision of equipment, documentation, and material specifications.
• Be responsible for product-related operations in cell culture/fermentation and bioreactor operations. Primarily focused on cell culture activities and small scale inoculum preparation.
• Develop effective working relationships with internal and external partners.
• Provide detailed observations, analyzes data, and interprets results.
• Perform a variety of complex tasks under general guidance and in accordance with current GMPs.
• Operate and maintain production equipment as it relates to cell culture - fermentation. Including, but not limited to: calibrations, preventative maintenance, initiating work orders, etc.

Must be able to work ON-SITE: Monday - Friday / 8:30am - 5:00pm and some weekends when needed.

Qualifications

• High school diploma or equivalent with a minimum of 2 years of experience in a cGMP regulated environment (specifically in Upstream Manufacturing).

• Knowledge of cell culture process steps including cell banking, thaw and expansion, production, and harvest.
• Experience with manufacturing of bulk drug substance following SOPs and batch records within a cGMP regulated environment.

Preferred Qualifications:

• Bachelor's degree.

Function

Sub Function

Reports To

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