Key Responsibilities and Duties:

Primary responsibility for:
Manufacturing operations to support production from start-to-finish of device and biologic products:
Processing upstream raw materials (porcine tissue)
Manufacturing downstream final device
Manufacturing downstream final biologic
Aseptic fill & finish
Filtration
Set-up and operate specialty equipment
Preparation of reagents
Tissue inspection and handling
Assist in the setup, breakdown, and cleaning of equipment and manufacturing areas before and after production runs
Collaborate with manufacturing and quality teams to ensure that facilities are prepared and ready for production activities as per schedule
Follow and document all procedures, including batch records, cleaning logs, and any other required documentation accurately and in a timely manner
Support a standard 40-hour work week with flexibility to support occasional off-shift hours and/or weekends
Sterilization – Autoclave
Lyophilization
In-process testing
Release testing
Secondary responsibility for:
Manufacturing process improvement
Inventory management, ensure adequate supply of raw materials, components, processing aids, etc.
Ordering supplies (electronically)
Perform routine environmental monitoring sampling. Coordinate with external lab for sample analysis. Perform evaluation of EM data.
Equipment logs
Laboratory management

Additional Responsibilities:Assist with ongoing product research and development projects
Work with team to investigate and qualify equipment needed for developed products and/or products in research and development stage
Assist with preparation of large-scale raw materials for processing and purification
Assist with maintaining laboratory equipment and instrumentation required for processing of material, or process control.
Become familiar with equipment and the overall processes in order to make recommendations based on results.
Assist Quality in preparation and completion of documentation, following cGMP practices
Follow GMP requirements and procedures.
Work with a team to provide consistent quality product at high efficiency
Perform other tasks, as assigned

Qualifications:

(Required)Bachelor’s degree or higher with experience in biochemistry, molecular biology, biology, or engineering principles preferred but not required, with equivalent past experience.
Ability to work in a cleanroom for 1-2 hours at a time
Experience with a broad range of production and test/inspection equipment and ability to do minor maintenance on equipment
Ability to work independently, and also collaborate as part of a multi-disciplinary team
Demonstrated ability to be highly organized and manage multiple priorities
Effective communication skills, both verbally and written
Good work ethic, reliable, and punctual
Strict adherence to established protocols
Flexibility to handle new and changing process steps / tests as they evolve[LS1] , and changing assignments
Proficiency in general laboratory techniques (e.g., pipette, sterile technique, weigh, titrate, reagent preparation)
Must have a desire to be part of a fast-paced and dynamic environment.
Ability to lift 15-25 pounds and stand for prolonged periods.

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