(CW) Manufacturing Associate
BioMarin Pharmaceutical Inc.
Full-time
On-site
Novato, CA
Operations
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Role Summary
(CW) Manufacturing Associate
Responsibilities
- PROCESS KNOWLEDGE: Understanding of process theory and equipment operation. Ability to 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: Understanding of cGMPs as related to Commercial Operations. Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).
- BUSINESS: Ability to participate on projects and contribute to outcomes. Capability to learn and support new business systems (Track wise, ERP, etc.). Support trending of defined department metrics.
Qualifications
- Required: Understanding of process theory and equipment operation; ability to learn biopharmaceutical manufacturing processes; ability to write and review process documents; knowledge of cGMPs; ability to use Quality systems.
- Preferred: Experience with automation systems (LIMS, MES, PI); experience with TrackWise or ERP systems; capability to participate in projects and track department metrics.
Skills
- Strong communication skills—verbal and written
- Ability to work in a team environment with conflict resolution and collaboration
- Initiative to identify areas for improvement and implement solutions
Education
- Bachelor’s degree in science or engineering is nice to have.
- Associate’s degree in science-related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry is nice to have.
Additional Requirements
- Hours: 6:00 PM to 7:00 AM; Alternating Sat/Sun - Tues
- Physical demands include strenuous, repetitive work; lifting up to 25 pounds; possible loud equipment; use of personal protective equipment; shift-based/off hours