IVD Reagent Manufacturing Specialist

Pattern Bioscience; Austin (TX); On-site; USD 50,000 - 75,000; Full time

Job summary

Pattern Bioscience in Austin is seeking a hands-on team member to deliver reagent manufacturing and testing to meet demand in an IVD environment. You will complete process documentation and system transactions accurately and participate in product design transfers and validations.

You will support experiments, update work instructions, assist in audits and CAPA, calibrate devices, and work with a collaborative team to improve efficiency and quality across manufacturing processes.

Qualifications

• Associate degree in Life Sciences, Chemistry, or Medical Technology with hands-on lab experience.
• Proficiency in Word/Excel and basic calculations with attention to detail.
• Hands-on HPLC experience and pipetting skills are essential.

Responsibilities

• Deliver reagent manufacturing and testing requirements to meet demand in an IVD environment
• Delivering timely and accurate completion of process documentation and related business system transactions
• Participating in new product design transfer, stability studies, process/test method development, equipment validations, and process/test method validations
• Supporting experimental plans with executing various parameter adjustments to equipment or formulations, document observations and results
• Assisting in executing projects targeting efficiency, scaling, and quality improvements
• Updating work instructions and standard operating procedures 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

Skills

Microsoft Word

Microsoft Excel

Mathematics aptitude

Hands-on HPLC experience

Pipetting

Attention to detail

Education

Associate degree in Life Sciences, Chemistry, or Medical Technology

Tools

HPLC instrumentation software

ISO 13485 knowledge

Enterprise Manufacturing systems

Job description

Pattern Bioscience in Austin is seeking a hands-on team member to deliver reagent manufacturing and testing to meet demand in an IVD environment. You will complete process documentation and system transactions accurately and participate in product design transfers and validations.

You will support experiments, update work instructions, assist in audits and CAPA, calibrate devices, and work with a collaborative team to improve efficiency and quality across manufacturing processes.