(CW) Manufacturing Associate (TEMPORARY)

Role Summary

Manufacturing Associate (Temporary) in BioMarin’s Technical Operations. This contract role involves supporting biopharmaceutical manufacturing processes, process optimization, and quality/compliance activities. Shift is a rotating 12-hour night schedule from 6 PM to 7 AM, Wednesday to Saturday, with alternating Saturdays.

Responsibilities

• Process knowledge: learn and operate biopharmaceutical manufacturing processes (e.g., mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, formulation of bulk drug substance). Support process optimization and identify/elevate processing issues with solutions. Gain experience with automation systems (LIMS, MES, PI, etc.).
• Technical documentation: provide feedback on procedures, assist in incorporating new technologies and standards, and write/review process documents.
• Quality and compliance: understand cGMPs related to Commercial Operations; utilize quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).
• Business: participate on projects, learn and support new business systems (TrackWise, ERP); assist in trending department metrics.

Qualifications

• Required: Bachelor‚Äôs degree in a science-related field or engineering; or Associate‚Äôs degree in science-related field or biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry.

Skills

• Strong verbal and written communication
• Ability to work in a team with conflict resolution and collaboration
• Initiative to identify improvement opportunities and implement solutions

Education

• Bachelor‚Äôs degree in science-related area or engineering
• Associate‚Äôs degree in science-related area or biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry

Additional Requirements

• Physically strenuous, repetitive work; movements include bending, reaching, climbing stairs and ladders, kneeling, and connecting equipment
• Ability to regularly lift, dispense, push, and/or pull items weighing approximately 25 pounds
• May work around loud equipment; PPE is required
• Shift-based work and off-hours availability