Manufacturing Operation Specialist I

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As a leading developer, manufacturer, and global supplier of scientific laboratory products for 100 years, Corning’s Life Sciences segment collaborates with researchers seeking new approaches to increase efficiencies, reduce costs and compress timelines in the drug discovery process. Using unique expertise in the fields of materials science, surface science, optics, biochemistry and biology, the segment provides innovative solutions that improve productivity and enable breakthrough discoveries.

Position Summary:

This role will be responsible for  safe, compliant, and accurate manufacturing, including coating, purification, and packaging of Corning’s dissolvable microcarrier products (DMC).  He/She will execute multi‑step chemical and polymer processes in accordance with validated procedures, maintain complete GMP documentation, perform equipment cleaning and setup, and ensure product quality, safety, and traceability throughout all stages of production.

Key Responsibilities:

Manufacturing & Processing

• Manufacture dissolvable microcarriers, including bead production, inspection and packaging.
• Prepare, calculate, mix, and verify chemical solutions and reagents within validated guidelines.
• Perform multi‑step synthesis and coating operations following approved Procedures
• Assist with equipment setup, changeovers, cleaning, line opening, and line clearance activities.

Cleaning & Equipment Readiness

• Perform and document deep cleaning of manufacturing equipment, reactors, pumps, and associated systems.
• Execute labware cleaning and depyrogenation processes per established procedures.
• Complete cleaning logs, inspections, and startup documentation to ensure equipment readiness and traceability.
• Maintain work areas and equipment in a clean, safe, and orderly condition.

Packout & Final Product Preparation

• Package dissolvable microcarriers into vials and bags per approved packing instructions.
• Perform drying, purging, filling, sealing, labeling, and packaging activities.
• Accurately complete all packout‑related data collection and batch documentation.

Quality & Regulatory Compliance

• Comply with GMP, ISO, and site‑specific quality system requirements.
• Perform required in‑process inspections and quality checks; monitor product for defects.
• Maintain accurate, complete, and contemporaneous documentation including batch records, logs, and signatures.
• Identify and segregate non‑conforming materials and initiate DMRs per procedure.
• Ensure lot number designation, traceability, and documentation accuracy.

Safety & Environmental Compliance

• Follow all lab and job‑specific safety requirements.
• Properly use PPE and demonstrate correct gowning practices for production areas.
• Safely handle, collect, and dispose of chemicals in coordination with Safety and HAZMAT requirements.
• Report unsafe conditions, equipment malfunctions, or unusual events to supervision immediately.

Collaboration & Continuous Improvement

• Work collaboratively with other functions meet production and quality goals.
• Escalate issues appropriately and request technical support when needed.
• Support process improvements, troubleshooting, and validation activities.
• Interact professionally with customers during site visits as required.

Required Knowledge, Skills, and Abilities:

• Understanding of chemical handling and/or manufacturing process
• Ability to read, understand, and follow technical procedures and visual work instructions.
• Proficiency with production and laboratory equipment, including scales, pumps, reactors, and computers.
• Strong attention to detail and commitment to documentation accuracy.
• Ability to work independently while maintaining strong teamwork and communication.

Training & Qualification Requirements:

• Completion of all required dissolvable microcarrier manufacturing, cleaning, coating, and packout training modules.
• Successful task verification by Trainer
• Demonstrated understanding of quality, safety, and administrative requirements.
• Ongoing compliance with retraining, qualification, and documentation standards.

Work Environment:

• GMP manufacturing and laboratory environments requiring gowning and PPE.
• Routine handling of chemicals and biological materials under controlled conditions.
• Physical requirements include standing, lifting, and fine motor skills.