Manufacturing Associate

About the role

Onsite contract position in Novato, CA 94949. Work schedule: Sunday to Tuesday with alternating Wednesdays, 06:00AM to 07:00PM.

Responsibilities

• Apply process knowledge of biopharmaceutical manufacturing, including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, centrifugation, protein purification, and formulation of bulk drug substance.
• Support process optimization initiatives and identify processing issues, providing solutions and feedback on operational procedures.
• Assist in the incorporation of new technologies, practices, and standards into procedures, including writing and reviewing process documents.
• Understand and utilize cGMP regulations and quality systems such as Deviations, CAPAs, Change Requests, and Action/Alert Reports.
• Participate in project teams, support new business systems like TrackWise and ERP, and contribute to department metrics trending.
• Engage in strenuous, repetitive physical work including bending, reaching, climbing stairs/ladders, kneeling, equipment connections, and lifting items weighing around 25 pounds.
• Work in a potentially loud environment, using personal protective equipment as required, with various shift-based and off-hours work schedules.

Requirements

• Bachelor's degree in science or engineering, or Associates degree in science related area, or biotech certificate with 2+ years of experience in biotech manufacturing or a regulated industry.
• Strong verbal and written communication skills.
• Ability to work effectively in a team environment, resolving conflicts and collaborating with colleagues.
• Good initiative to identify improvement opportunities and implement solutions.