Reagent Manufacturing Associate

Key Responsibilities

• Deliver reagent manufacturing and testing requirements to meet demand in an IVD environment.
• Deliver timely and accurate completion of process documentation and related business system transactions.
• Participate in new product design transfer, stability studies, process/test method development, equipment validations, and process/test method validations.
• Support experimental plans by executing various parameter adjustments to equipment or formulations, documenting observations and results.
• Assist in executing projects targeting efficiency, scaling, and quality improvements.
• Update work instructions and standard operating procedures (SOPs) and related change control.
• Support investigations and resolution of findings identified through audits, non-conformances, key performance indicator trends, corrective/preventive actions, or customer complaints escalation.
• Work in a team environment to coordinate activities, solve problems, and communicate.
• Deliver maintenance and calibration of measuring and monitoring devices.

Requirements & Tech Stack

• Proficient in Microsoft Word and Excel.
• Possess mathematics aptitude to perform and document basic calculations.
• Hands-on HPLC experience.
• Proficient at pipetting.
• Adapt easily in a flexible and changing environment.
• High attention for detail and stay focused on repetitive tasks.
• Drive to solve problems.
• Apply critical thinking and analysis to your work.
• Enjoy working self-directed and independently as well as collaborating with others in an open environment.
• Are a continuous learner.

Qualifications

• Associate degree in a field of Life Sciences, Chemistry, or Medical Technology.
• Experience pipetting in a lab.
• Experience working in hands-on IVD manufacturing environments or other relevant process experience.

Skills or Attributes Considered a Plus

• Familiarity evaluating HPLC data.
• Familiarity with ISO 13485:2012 and FDA Quality System requirements.
• Familiarity with Enterprise Manufacturing systems.
• Experience in Reagent Manufacturing and measurement methods.
• Experience working in cleanrooms, laminar flow hoods, or BSL2.
• Experience with lyophilization.
• Proficiency in aseptic technique.
• Experience in making McFarland's and counting bacterial colonies.
• Planning and executing experimental plans.
• Experience with clinical microbiology.