Reagent Manufacturing Associate

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

At Pattern Bioscience, we’re tackling antibiotic resistance, named by the CDC as one of the biggest public health challenges of our time. We use AI and single-cell analysis to quickly recognize the bacteria causing an infection and to predict which drugs will cure the infection. Our team is brought together by shared passion for our mission to improve the world’s most important health decisions. However, we’re not only invested in combating antibiotic resistance; we’re also invested in our people.

Our next milestones are to optimize processes and scale consumable manufacturing output in support of product development through commercialization.

How You Will Contribute

• 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

We’d Love to Hear from You If You

• Are proficient in Microsoft Word and Excel
• Possess mathematics aptitude to perform and document basic calculations
• Have hands-on HPLC experience
• Are proficient at pipetting
• Adapt easily in a flexible and changing environment
• Have high attention for detail and stay focused on repetitive tasks
• Have a 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 open environment
• Are a continuous learner

Education and Experience

Minimum: Associate degree in a field of Life Sciences, Chemistry, or Medical Technology with experience pipetting in a lab and 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

We value diversity on our teams. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity or expression, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.