Manufacturing Associate, Upstream
3 months ago
Salary: $65-80k depending on experience Responsibilities:
- Performs manufacturing activities according to cGMP guidelines, including batch record execution, product and equipment changeover, manufacturing equipment troubleshooting, issue resolution.
- Execute process operations in accordance to dynamic production timeline.
- Ensure safety and cGMP compliance in manufacturing area at all times
- Communicate transparently with management.
- Cell culture expansions and aseptic techniques
- Operate 20L and 50L Rocker Modules, including familiarity with Unicorn control system
- Operate and maintain NOVA Analyzers
- TFF Harvest operations
- Develop and author necessary supporting cGMP documentation that supports all Cell Culture manufacturing processes.
- Successfully maintain aseptic gowning qualification status and participate in annual media fills.
- Effectively engage cross-functionally with other departments in order to stream-line all operations supporting cGMP manufacturing.
- Cross-train on and assist with Downstream operations as required.
- Contribute to and develop process improvement initiatives with all Cell Culture manufacturing equipment and operations.
- Assist or execute ordering of material and ensure that equipment and materials are available for production runs.
- Maintain and sustain all organizational training profile requirements.
- Perform all other duties as assigned
- BS/BA in a life science discipline; 0-4+ years of experience in biotechnology/pharmaceutical industry – both recent grads and experienced are highly encouraged to apply
- Ability to multitask projects simultaneously and prioritize projects.
- Fluency with MS Office (Word/Excel/PowerPoint/Project/Visio/OneNote)
- Excellent oral and written communication skills.
- Must have ability to perform work while wearing the appropriate gowning material for cleanroom environments and work under aseptic conditions in a class 100 environment (BSC).
- Ability to work weekends occasionally to support the dynamic production schedule and relevant timelines.
- Ability to occasionally work extended shift hours to support the dynamic production schedule and relevant timelines.
- Must have the ability to manage up to fifty (50) pounds at a time and stand for extended periods of time while wearing appropriate clean room gowning material and appropriate personal protective equipment is required.
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