Manufacturing Associate

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