(CW) Manufacturing Associate (Temporary/Contract)

Job Description

This a contract /Temporary role - Contract length 1 year Multiple roles (3)

Shift is Sunday – Tuesday 6:00 p.m. - 7:00 a.m., with alternating Saturdays

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, 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.).

Technical Documentation

• Provide feedback and/or suggested changes to operational procedures.
• Absorb and incorporate 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.
• Able 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/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.

Skills

• 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

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