Reagent Manufacturing Associate

Pattern Bioscience, Inc.; Austin (TX); On-site; USD 25,000 - 39,000; Full time

Job summary

Pattern Bioscience, Inc. seeks a reagent manufacturing associate to deliver manufacturing and testing in an IVD environment, with documentation and process control responsibilities.

You will support new product design transfers, stability studies, and method development, while ensuring equipment validation and quality standards are met. The role requires an Associate degree in life sciences or related field, hands-on lab experience with pipetting and HPLC, and proficiency with Word/Excel.

Qualifications

• Associate degree with hands-on lab experience in IVD manufacturing.
• Experience with pipetting and documentation.
• Familiarity with ISO 13485 and FDA QSR requirements.

Responsibilities

• Deliver reagent manufacturing and testing requirements for IVD environment.
• Complete process documentation and related business system transactions.
• Participate in product design transfer, stability studies, and method validations.
• Support experimental plans with parameter adjustments and observations.
• Assist in projects targeting efficiency, scaling, and quality improvements.
• Update work instructions, SOPs, and change controls.
• Assist investigations and CAPA closures from audits or customer feedback.
• Coordinate activities within a team and communicate effectively.
• Deliver maintenance and calibration of measuring devices.

Skills

Mathematics aptitude

Attention to detail

Critical thinking

Problem solving

Self-directed work style

Team collaboration

Education

Associate degree in Life Sciences, Chemistry, or Medical Technology

Tools

HPLC

Pipetting

ISO 13485 knowledge

FDA Quality System understanding

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.

As set forth in Pattern Bioscience’s Equal Employment Opportunity policy,we do not discriminate on the basis of any protected group status under any applicable law.