Manufacturing Operator

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Instylla, Inc. is a privately held medical device company based in Bedford, MA, focused on developing novel resorbable embolic agents to advance interventional radiology, with initial clinical applications in interventional oncology. Instylla was founded in 2017 by Incept LLC and is funded by several leading venture capital groups. The company’s flagship product, Embrace™ Hydrogel Embolic System, is FDA-approved for hypervascular tumor embolization and offers controlled, targeted, and persistent embolization.

The Manufacturing Operator is responsible for executing manufacturing activities including primary packaging, formulation and filling, and final product packaging and shipment while following appropriate Instylla Standard Operating Procedures (SOP) under their supervisor’s direction. This position will support the production of several different product lines which vary from general packaging exercises to formulation and filling processes.

• Work within an ISO Class 8 Cleanroom, including low dexterity environments such as glove boxes, and fume hoods.
• Execute manufacturing activities following Standard Operating Procedures, Equipment Instructions, Work Instructions and other documented practices.
• Perform in-process inspections to verify items conform to specifications, workmanship standards, and procedures.
• Execute responsibilities in accordance with current Good Manufacturing Practices and Good Documentation Practices.

• 1-3 years of manufacturing experience in Medical Device, Pharmaceutical, or Biotechnology.
• Experience reading and following manufacturing documents such as work instructions, process routers, batch records, etc.
• Working knowledge of Good Manufacturing Practices and Good Documentation Practices.
• Good written and verbal communication skills with ability to speak effectively with peers, auditors, service suppliers and management.

• Excellent hand/eye coordination and specific vision abilities required including color vision, close vision and ability see fine details under magnification.
• Operate laboratory instruments such as balances, pH meters, pipettes, etc.
• Attention to detail needed to execute production procedures, perform product inspections, accurately complete documented records and ensure compliance to SOPs and other documented practices.
• Must be able to multi-task, meet established deadlines and work with supervisor to prioritize changing demands.
• Ability to work independently or with teams.
• Takes responsibility for assignments. Must be self-motivated and possess good organizational skills.
• Must have a commitment to quality and safety.
• Must have clear and legible handwriting.

• Experience working with glove boxes and fume hoods.
• Experience working in batch manufacturing.
• Experience in the manufacturing of devices containing liquids; working knowledge of chemical handling and formulation.

• Ability to work in cleanroom garments
• Ability to work in standing and/or seated positions for up to 4 hours at a time
• Ability to lift up to 50 pounds
• Ability to work in office, chemical laboratories, and assembly environments