At Pattern Bioscience, we’re tackling antibiotic resistance, one of the biggest public health challenges of our time.  We use machine learning and microfluidics to quickly recognize the bacteria causing an infection and to predict which drugs will cure the infection.

We are hiring an Analytical Chemist to join our Consumable Manufacturing team during a critical inflection point in our company journey. We are actively investing in scaling our consumable production while developing the next assays for our platform. Your work will be key in ensuring precision in and quality of our reagent formulations for both current and future assays. Through your work, you will have the opportunity to work with research and process scientists, reagent manufacturing associates, and quality and automation engineers.

Three Month Goals

• Support development and validation of analytical methods for new assay panel research and development
• Independently manage routine HPLC qualification of manufacturing materials
• Independently manage inventory of reference materials and check standards to support HPLC program

How You Will Contribute

• Develop, optimize, and validate HPLC methods used for raw material, in-process, and finished reagent testing.
• Perform routine and non-routine HPLC and other analytical instrumentation testing (pH, conductivity, UV-Vis, refractometry, FTIR, NMR etc) to support batch release, stability studies, and process/manufacturing support.
• Following released procedures, formulate analytical standards for use in HPLC analysis.
• Troubleshoot chromatographic and instrument issues (columns, mobile phases, detectors, autosamplers, pumps) to minimize downtime and maintain lab operations.
• Author, review, and revise analytical test methods, SOPs, and work instructions; support the creation and execution of method validation protocols and reports.
• Support method transfer, method development, and equipment/test method validation activities for new and existing products.
• Analyze and interpret analytical data, including trending and statistical process control (SPC), to monitor equipment, method, and process performance over time.
• Investigate out-of-specification (OOS) and out-of-trend (OOT) results and atypical events; support nonconformance root cause analysis and CAPAs.
• Maintain, calibrate, and qualify analytical equipment systems and associated laboratory instrumentation; coordinate preventive maintenance and service with vendors.
• Partner with R&D, Manufacturing, and Quality teams to define material specifications, test methods, and acceptance criteria for reagents and raw materials.
• Maintain compliance with Good Documentation Practices, data integrity principles, and 21 CFR Part 11 requirements for all laboratory records and electronic data.
• Provide training and oversight to laboratory personnel on analytical methods, instrument operation, and data review.
• Support internal and external audits and regulatory inspections related to analytical testing.
• Are a thorough and relentless problem-solver, pursuing issues to their root cause.
• Keep the big picture in mind, knowing what needs to happen today to enable projects for later in the week, engaging subject matter experts or other teams as needed.
• Stay calm, adaptable, and flexible under changing priorities and the introduction of new methods.
• Excel in data analysis, particularly for chromatography data.
• Communicate clearly and efficiently in both oral and written formats, including technical writing and GxP documentation.

Desired Education and Experience

• B.S. in Chemistry, Biochemistry, Chemical Engineering, or a related scientific field.
• Min 2 years of hands-on HPLC and/or analytical chemistry laboratory experience, preferably within a regulated (GxP, FDA, or ISO 13485) environment.
• Demonstrated hands-on experience in analytical method development, qualification, validation, routine operation and troubleshooting.
• Working knowledge of complementary analytical techniques (e.g., UV-Vis/spectrophotometry, NMR, FTIR) is a plus.
• A strong understanding of FDA regulations and ISO 13485 requirements for IVD medical device development and production.
• Proficiency with chromatography data systems (e.g., Empower, Chromeleon, or similar CDS software).
• Understanding of cleanroom operations, BSL2 protocols, Good Documentation Practice, and GxP data integrity requirements.

Details

This is an exempt, salaried, full-time position on our Consumable Manufacturing team. 

Join us! We're excited for what you can bring to our team. Here are a few things we provide to make sure you have a great experience. Learn more about our team by visiting our website.

Benefits

• Health insurance
• 401k Matching
• Paid Time Off
• The opportunity to make a global impact

To fulfill our mission and build world-changing technology, we’ve put together a diverse, multi-disciplinary top-notch team, a culture of innovation, learning, adaptability, and excellence and environment where people love coming to work.

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.