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This is a contract role: ***Shift schedule rotating 12-hour night shift from 6PM to 7AM. Wednesday to Saturdays. Alternating Saturdays***. Work Environment/Physical Demands: Consists of strenuous, repetitive work. The following list of physical movements may be used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands. 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.
Job Responsibility:
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.)
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
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
Requirements:
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
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
What we offer:
discretionary annual bonus
discretionary stock-based long-term incentives
paid time off
company-sponsored medical, dental, vision, and life insurance plans
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