Biopharmaceutical Manufacturing Associate, Downstream

Manufacturing Associate, Downstream

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Location: Tustin, CA

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Schedule: Sunday - Wednesday, 7:00am to 6:00pm (4x10 schedule)

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Join a passionate team dedicated to developing and manufacturing life-saving biopharmaceuticals. As a Manufacturing Associate, Downstream, you will play a key role in a multi-product manufacturing facility, ensuring compliance with cGMP and SOPs. Responsibilities include production, documentation, report writing, materials procurement, and equipment scheduling. You will operate and maintain BioProcess chromatography skids, handle chromatography columns, execute purification techniques (Affinity, Size Exclusion, Ion Exchange, Hydrophobic Interaction, TFF), calibrate meters, manage filtration processes, and demonstrate exceptional aseptic techniques. Additional duties include participating in product filling, maintaining cleanroom facilities, monitoring inventory, revising documentation, leading projects, preparing media and buffer solutions, cleaning equipment, performing filter integrity testing, and operating autoclaves.

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Minimum Qualifications:

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• 2+ years of related experience and/or training, or equivalent combination of education and experience.
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• 2+ years of hands-on experience in biopharmaceutical manufacturing, specifically in downstream processing and chromatography systems.
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• Associate or bachelor’s degree (preferably in Biology or Chemistry)
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• 2+ years of experience with large-scale liquid chromatography columns or similar equipment
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• 1+ years of experience in the life sciences industry
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• 2+ years of experience in GMP production environments and aseptic techniques
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• Ability to gown for cleanroom environments and work under aseptic conditions
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Compensation & Benefits:

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- Bonus, stock equity, and comprehensive benefits (health, dental, vision, 401(k) matching, PTO)

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- Career growth and development opportunities

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Who You Are:

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- Team player with a positive attitude

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- Excellent written and verbal communication skills

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- Strong multitasking and attention to detail

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- Skilled at building relationships with team members and stakeholders

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Applicants must be legally authorized to work in the United States for any employer. Sponsorship is not available for this position now or in the future.