Upstream Manufacturing Associate - West Chester, PA

Role Summary

Upstream Manufacturing Associate located in West Chester, PA. Responsible for product-related operations in cell culture/fermentation and bioreactor operations, primarily focused on cell culture activities and small-scale inoculum preparation. Operates and maintains production equipment related to cell culture and fermentation, and supports GMP-compliant manufacturing processes.

Responsibilities

• Responsible for product-related operations in cell culture/fermentation and bioreactor operations, primarily focused on cell culture activities and small scale inoculum preparation.
• Operates and maintains production equipment as it relates to cell culture – fermentation, including calibrations, preventative maintenance, initiating work orders, etc.
• Performs a variety of complex tasks under general guidance and in accordance with current GMPs.
• Drafts, executes, documents and reviews data and approval of SOPs and batch records according to GMP guidelines.
• Maintains records to comply with regulatory requirements and performs daily in-process testing.
• Provides detailed observations, analyzes data, and interprets results.
• Assisting in audits from internal or external partners.
• Performs other related duties as required.

Qualifications

• Bachelor's degree OR 0-3 years of relevant industry experience
• Experience with manufacturing of bulk drug substance following SOPs and batch records within a cGMP regulated environment highly preferred
• Good written and verbal communication and interpersonal skills
• Ability to summarize and share operational updates
• Willingness to work weekends and holidays as needed

Skills

• Operational understanding of cell culture and fermentation processes
• Data analysis and interpretation
• Documentation and GMP compliance
• Auditing support and collaboration

Education

• Bachelor's degree or equivalent in a relevant field

Additional Requirements

• Willingness to work weekends and holidays as needed