Bioprocess Technician - Clinical Supply Center (Multiple Shifts Available)

The Bioprocess Technician will be comfortable with ambiguity, have an entrepreneurial spirit within a GMP environment, have demonstrated strong Pharma Technical Behaviors, and have an agile mindset. Ability to collaborate is crucial as success will be measured as a member of a team, not just as an individual.

In this role the Bioprocess Technician will be part of the CSC Main Operation team that executes all operation activities on the production schedule. The candidate will establish relationships with customer groups and peers by seeking opportunities for collaboration, proactively communicating and become proficient on the end to end process from Solution Preparation to Downstream. Candidates are initially expected to have a fundamental understanding of the cell culture and purification process and will develop additional expertise over time through a combination of role assignments and coaching.

The Opportunity

• Accountable for ensuring that production timelines are met
• Perform a variety of tasks to ensure that all the materials, recipes and consumables are available when needed. (e.g. ASPIRE/ SAP, 5S)
• Execute main operation activities associated with Upstream and Downstream operations (e.g. inoculation, batch and prep, harvest, chromatography, viral filtration). Will also support Solution Prep activities as needed.
• Perform routine EM and WFI sampling and EMS verification.
• Perform accurate real-time documentation on all required worksheets and software.
• Proactive communication with management, researchers and peers to provide feedback on operations.
• Operation and understanding of automation/process systems. (e.g. Syncade, DeltaV, MES, Single LIMS)
• Exercise good independent judgment and provide potential solutions to problems based on experience with GLP, cGMP, QMS, Lean Manufacturing principles.
• Ability to work with minimal supervision.
• Strong behaviors aligned with Pharma Technical (PT) expectations including Lean/Agile, collaboration, speaking up, decision making and continuous improvement
• Ability to work in an agile and ambiguous environment
• Commitment to quality and excellence
• Growth mindset with a passion for taking on challenges in order to deliver business value while developing
• Entrepreneurial spirit within a GMP environment

Operational Responsibilities

• To ensure operation activities are executed on time and according to procedures.
• Drives continuous improvement in our process to gain efficiency.
• Collaborates proactively with peers and support groups (e.g. Automation, Quality, Vendor, and Facility) to ensure robust communication.
• Understands Drug Substance process parameters and is able to recognize when there is an issue.
• Escalate Basecamp recipe issues and ensure they are being addressed in a timely manner.
• Facilitates communication and information transfer between different groups.

Who You Are

• BA/BS in a life science, engineering or equivalent is preferred with at least three years of relevant work experience
• Ability to work in fast paced dynamic work environment
• Experience using single use technology
• Ability to prioritize project assignments, to meet deadlines, be flexible in workload priorities, and to recognize and accurately report problems
• Proven excellent in customer service and ability to problem-solve and make decisions
• Working conditions include extensive walking/standing, ability to lift, push and pull up to 30 pounds
• Be able to work a flexible schedule (e.g Day, Weekend and Swing Shift Schedule)