Analytical Chemist

Pattern Bioscience•Austin, TX

About The Position

Pattern Bioscience is hiring an Analytical Chemist for its Consumable Manufacturing team as the company scales consumable production and develops new assays. The role supports the precision and quality of reagent formulations for current and future assays, working with research and process scientists, reagent manufacturing associates, and quality and automation engineers. The Analytical Chemist develops, optimizes, validates, and runs analytical methods—primarily HPLC—for raw materials, in-process materials, and finished reagents. The position also supports batch release, stability studies, manufacturing and process activities, method and equipment validation, data review, investigations, and audit readiness. It maintains analytical equipment and laboratory records in accordance with applicable documentation, data integrity, and regulatory requirements. During the first three months, the role is expected to support development and validation of analytical methods for new assay panel research and development, independently manage routine HPLC qualification of manufacturing materials, and independently manage reference material and check standard inventories for the HPLC program.

Requirements

Bachelor of Science in Chemistry, Biochemistry, Chemical Engineering, or a related scientific field.
At least 2 years of hands-on HPLC and/or analytical chemistry laboratory experience.
Hands-on experience in analytical method development, qualification, validation, routine operation, and troubleshooting.
Proficiency with chromatography data systems such as Empower, Chromeleon, or similar CDS software.
Understanding of cleanroom operations, BSL2 protocols, Good Documentation Practice, and GxP data integrity requirements.
Strong data analysis skills, particularly with chromatography data.
Clear and efficient oral and written communication, including technical writing and GxP documentation.
Thorough problem-solving, including pursuing issues to their root cause; ability to manage priorities, adapt to changing priorities and new methods, and engage subject matter experts or other teams as needed.

Nice To Haves

Analytical chemistry laboratory experience in a regulated GxP, FDA, or ISO 13485 environment.
Working knowledge of complementary analytical techniques such as UV-Vis/spectrophotometry, NMR, and FTIR.
Strong understanding of FDA regulations and ISO 13485 requirements for IVD medical device development and production.

Responsibilities

Develop, optimize, and validate HPLC methods for raw material, in-process, and finished reagent testing.
Perform routine and non-routine HPLC and other analytical instrumentation testing to support batch release, stability studies, and process and manufacturing support.
Formulate analytical standards for HPLC analysis according to released procedures.
Troubleshoot chromatographic and instrument issues, including columns, mobile phases, detectors, autosamplers, and pumps.
Author, review, and revise analytical test methods, SOPs, and work instructions; support method validation protocols and reports.
Support method transfer, method development, and equipment and test method validation for new and existing products.
Analyze and interpret analytical data, including trending and statistical process control, to monitor equipment, method, and process performance.
Investigate out-of-specification and out-of-trend results and atypical events; support nonconformance root-cause analysis and CAPAs.
Maintain, calibrate, and qualify analytical equipment and laboratory instrumentation; coordinate preventive maintenance and vendor service.
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 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.
Support development and validation of analytical methods for new assay panel research and development.
Independently manage routine HPLC qualification of manufacturing materials.
Independently manage reference material and check standard inventory for the HPLC program.