Reagent Manufacturing Associate

Pattern Bioscience; Austin (TX); Presencial; USD 55.000 - 75.000; Jornada completa

Descripción de la vacante

Pattern Bioscience is hiring for a lab-based manufacturing role focused on reagent production and testing in an IVD environment. You will document processes, participate in design transfers, and support validation activities.

Candidates bring hands-on lab experience, proficiency with HPLC, pipetting skills, and strong attention to detail. Ideal applicants hold an associate degree in life sciences or related field, with familiarity with quality systems and enterprise manufacturing software.

Formación

• Minimum: Associate degree in Life Sciences, Chemistry, or Medical Technology with hands-on lab experience and IVD manufacturing exposure.
• Familiarity with documentation, change control, and quality systems is a plus.
• Experience pipetting and handling analytical instruments in a manufacturing or clinical setting.

Responsabilidades

• Deliver reagent manufacturing and testing requirements to meet demand in an IVD environment.
• Complete process documentation and related business system transactions accurately and timely.
• Support new product design transfer, stability studies, and equipment validations.
• Assist in experimental plans and parameter adjustments with proper documentation.
• Contribute to projects targeting efficiency, scaling, and quality improvements.
• Update work instructions and SOPs and participate in change control.
• Support investigations and CAPA in audits, non-conformances, and customer escalations.
• Collaborate in a team to coordinate activities and communicate effectively.
• Maintain and calibrate measuring and monitoring devices.

Conocimientos

MS Word

MS Excel

HPLC experience

Pipetting

Attention to detail

Problem solving

Critical thinking

Independent work

Educación

Associate degree in Life Sciences / Chemistry / Medical Technology

Herramientas

Enterprise Manufacturing systems

Descripción del empleo

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.