Manufacturing Associate (Night Shift)
Job Description
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. 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 in projects and contribute to outcomes. Capability to learn and support new business systems (Track-wise, ERP, etc.). Support trending of defined department metrics.
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 a science-related area or engineering
- Associate's degree in a science-related area or a Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry
Timings
Shift is Sunday - Tuesday 6:00 p.m. - 7:00 a.m., with alternating Saturdays