Manufacturing Technician I

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. Founded in 2017 by Incept LLC and funded by leading venture capital groups, Instylla’s flagship product, Embrace™ Hydrogel Embolic System, is FDA-approved for hypervascular tumor embolization and offers controlled, targeted, and persistent embolization.

About the role

The Manufacturing Technician I executes manufacturing activities including primary packaging, formulation and filling, and final product packaging and shipment while following Instylla Standard Operating Procedures (SOP) under supervision. This role supports production across multiple product lines, ranging from general packaging to formulation and filling processes.

Responsibilities

• Work within an ISO Class 8 Cleanroom, including low-dexterity environments such as gloveboxes 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 (cGMP) and Good Documentation Practices (GDP).

Requirements

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

Skills

• Excellent hand/eye coordination and vision abilities, including color vision, close vision, and ability to see fine details under magnification.
• Operate laboratory instruments such as balances, pH meters, and pipettes.
• Attention to detail for executing production procedures, performing product inspections, and accurately completing documented records.
• Ability to multi-task, meet deadlines, and prioritize changing demands with supervisor input.
• Ability to work independently or in teams; self-motivated with strong organizational skills.
• Commitment to quality and safety.
• Clear and legible handwriting.

Preferred Skills

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

Working Conditions

• 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.