Job Description
Job Title: Upstream and Downstream Manufacturing Associate Openings!
Position Summary:
We currently have openings supporting both our teams within upstream and downstream manufacturing operations. The ideal candidate will bring strong technical expertise in cell culture, bioreactor operations, harvest clarification, and compliance-driven batch execution.
Essential Duties & Responsibilities
Upstream Responsibilities:
- Collaborate with manufacturing associates and engineers to execute upstream batches, supporting production timelines and quality standards.
- Perform cell culture operations and manage single-use fed-batch bioreactors at varying production scales ideally 2,000+ lt.
- Monitor, analyze, and adjust bioprocess parameters using real-time data collection systems and control strategies.
- Interpret and execute instructions from protocols, SOPs, batch records, diagrams, and schedules.
- Maintain cleanliness, organization, and compliance in all upstream operations per GMP and EH&S policies.
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Downstream Responsibilities:
- Conduct harvest clarification using centrifuges and depth filtration systems across multiple batch sizes.
- Support downstream processing techniques for material recovery and intermediate preparation.
- Coordinate and implement corrective actions for issues encountered during downstream processing.
- Review executed manufacturing and packaging batch records and support audit readiness.
- Ensure timely and compliant execution of clinical and engineering batches, supporting continuous process improvement efforts.
Requirements
Education & Experience:
- Bachelor’s or Master’s degree in Chemical, Biological, or Biochemical Sciences.
- Minimum of 3+ years of industry experience in biopharmaceutical manufacturing, preferably across both upstream and downstream operations.
- Proven ability to design, execute, and document process development stages independently.
Knowledge & Skills:
- Strong foundation in GMP-compliant batch processing, including both aseptic techniques and single-use technologies (bags, tubing sets, columns, manifolds).
- Familiarity with bioprocess software tools for data collection and analysis.
- Excellent communication, collaboration, and organizational skills.
- High attention to detail and proficiency in software such as Microsoft Word and Excel.
- Knowledge of cleaning validation and batch record auditing best practices.