(CW) Manufacturing Associate (TEMPORARY)
BioMarin Pharmaceutical Inc.
Full-time
On-site
Novato, CA
$15 - $30 USD yearly
Operations
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Role Summary
(CW) Manufacturing Associate (TEMPORARY) at BioMarin
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: Bachelor’s degree in science-related area 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.
- Preferred: Experience with biopharmaceutical manufacturing processes and familiarity with GMP/compliance systems.
Skills
- Strong communication skills—verbal and written
- Ability to work in a team environment with good conflict resolution and collaboration
- Initiative to identify areas for improvement and implement solutions
Education
- Bachelor’s degree in science-related area or engineering (nice to have)
- Associate’s degree in science-related area or Biotech certificate with 2+ years of experience (nice to have)
Additional Requirements
- Hours: 6:00 PM to 7:00 AM; Alternating Sat/Sun - Tues
- Physical demands: Lifting up to 25 pounds; possible loud environment; use of personal protective equipment required; shift-based/off-hours work