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.

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.

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