(CW) Manufacturing Associate (TEMPORARY)

Role Summary

(CW) Manufacturing Associate (TEMPORARY) at BioMarin. Responsible for supporting biopharmaceutical manufacturing processes and related activities in Technical Operations, including process knowledge, technical documentation, quality and compliance, and business system support. Works in a shifting schedule and complies with cGMP standards to help move drugs to patients.

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 process optimization initiatives. Identify and elevate processing issues and support solutions. Gain experience with automation systems (LIMS, MES, PI, etc.).
• TECHNICAL DOCUMENTATION: Provide feedback or suggested changes to operational procedures. Assist in incorporating new technologies, practices, and standards into procedures. Capable of writing and reviewing process documents.
• QUALITY AND COMPLIANCE: Understand cGMPs as related to Commercial Operations. Utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).
• BUSINESS: Participate in 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 field or engineering; or Associate’s degree in science-related field or biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry.
• Preferred: Experience with biopharmaceutical manufacturing processes; familiarity with cGMP and quality systems.

Skills

• Strong verbal and written communication
• Team collaboration and conflict resolution
• Initiative to identify improvements and implement solutions

Education

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

Additional Requirements

• Work environment/physical demands: strenuous, repetitive work; daily motions include bending, reaching, climbing stairs and ladders, kneeling, and making equipment connections; ability to lift/push/pull items averaging 25 pounds; possible work around loud equipment; PPE required; shift-based hours including evenings/nights and weekends as needed.