Upstream Manufacturing Associate - West Chester, PA
Teva Pharmaceuticals
Full-time
Remote friendly (West Chester, PA)
United States
Operations
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Role Summary
Upstream Manufacturing Associate - West Chester, PA. Responsible for product-related operations in cell culture/fermentation and bioreactor operations, with focus on cell culture activities and small scale inoculum preparation. Operates production equipment related to cell culture and fermentation, performs tasks under GMP guidelines, and contributes to data review and regulatory compliance.
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
- Required: Bachelor's degree OR 0-3 years of relevant industry experience
- Preferred: Experience with manufacturing of bulk drug substance following SOPs and batch records within a cGMP regulated environment
- Required: Good written and verbal communication and interpersonal skills
- Required: Ability to summarize and share operational updates
- Required: Willingness to work weekends and holidays as needed
Skills
- Cell culture and fermentation operations
- GMP and regulatory documentation
- Data analysis and interpretation
- Operational communication and reporting
Education
- Bachelor's degree or equivalent experience in a relevant field
Additional Requirements
- Weekend/holiday work availability as needed