(CW) Manufacturing Associate (TEMPORARY)

Role Summary

(CW) Manufacturing Associate (TEMPORARY) at BioMarin. Responsible for supporting biopharmaceutical manufacturing processes, ensuring quality and compliance, and contributing to process optimization in a GMP-regulated environment.

Responsibilities

• PROCESS KNOWLEDGE: Understand process theory and equipment operation. Learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance. Support initiatives for process optimization. Identify and elevate processing issues and support solutions. Gain experience with automation systems (LIMS, MES, PI, etc.).
• TECHNICAL DOCUMENTATION: Provide feedback and/or suggested changes to operational procedures. Assist in the incorporation of new technologies, practices, and standards into procedures. Capable of writing and reviewing process documents.
• QUALITY AND COMPLIANCE: Understand cGMPs as related to Commercial Operations. Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).
• BUSINESS: Participate on projects and contribute to outcomes. Learn and support new business systems (TrackWise, ERP, etc.). Support trending of defined department metrics.

Qualifications

• Required: Understanding of process theory and equipment operation; ability to learn biopharmaceutical manufacturing processes; familiarity with quality systems and cGMPs.
• Preferred: Experience with automation systems (LIMS, MES, PI); ability to write and review process documents; prior experience in biotech manufacturing or regulated industry; track record of contributing to process improvements.

Skills

• Strong verbal and written communication
• Teamwork with conflict resolution and collaboration
• Initiative to identify areas for improvement and implement solutions

Education

• Bachelor‚Äôs degree in science or engineering preferred
• Associate‚Äôs degree in science or biotech certificate with 2+ years of biotech manufacturing or regulated industry experience

Additional Requirements

• Work environment includes strenuous, repetitive work; may involve bending, reaching, climbing stairs/ladders, kneeling, and frequent equipment connections
• Ability to regularly lift up to 25 pounds
• May work around loud equipment; personal protective equipment required
• Shift-based work and off hours required