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This is a contract role: Days: Sun-Tues/Wed 0600-1900. BioMarin’s Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market.
Job Responsibility:
PROCESS KNOWLEDGE: Understanding of process theory and equipment operation
Support initiatives for process optimization
Identify and elevate processing issues and support solutions
TECHNICAL DOCUMENTATION: Provide feedback and/or suggested changes to operational procedures
Assist in the incorporation of new technologies, practices, and standards into procedures
QUALITY AND COMPLIANCE: Understanding of cGMPs as related to Commercial Operations
BUSINESS: Ability to participate on projects and contribute to outcomes
Support trending of defined department metrics
Requirements:
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
Strong communication skills—verbal and written
Ability to work in a team environment which includes good conflict resolution and collaboration
Displays good initiative to identify areas for improvement and implement solutions
Understanding of cGMPs as related to Commercial Operations
Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.)
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
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
Gain experience with automation systems (LIMS, MES, PI, etc.)
Capable of writing and reviewing process documents
Consists of strenuous, repetitive work
Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds
May require work around loud equipment
The use of personal protective equipment will be required
Requires various shift based work and off hours
What we offer:
discretionary annual bonus
discretionary stock-based long-term incentives
paid time off
company-sponsored medical, dental, vision, and life insurance plans