Manufacturing Associate

Shift Details: Night Shift - Rotating 12hr shift. Hours: 6:00pm – 7:00am / Days: Sunday to Tuesday with alternating Wednesdays.

Starting October 5th- new schedule Sunday – Tuesday and every other Saturday, 6 PM – 7AM (Sat/Sun – Tuesday).

PROCESS KNOWLEDGE:
Understanding of process theory and equipment operation
Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, protein purification and formulation of bulk drug substance
Support initiatives for process optimization
Identify and elevate processing issues and support solutions
Demonstrated proficiency 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:
Understanding of cGMPs as related to Commercial Operations
Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.)

BUSINESS:
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

WORK ENVIRONMENT/PHSYICAL DEMANDS:

Consists of strenuous, repetitive work. The following list of physical movements maybe used daily: bending, reaching, climbing stairs and ladders, kneeling, and making numerous equipment connections using hands and tools. Independently can 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.

REQUIREMENTS:

BA/BS and 1-2 years of industry experience desired but not required