Analytical Chemist: HPLC & GxP Method Dev

Pattern Bioscience; Austin (TX); Presencial; USD 85.000 - 120.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Health insurance

401k Matching

Paid Time Off

The opportunity to make a global #{imp

Descripción de la vacante

Pattern Bioscience is seeking an Analytical Chemist to join our Consumable Manufacturing team in Austin. You will develop, validate, and transfer HPLC methods for raw materials, in-process samples, and finished reagents to support batch release and stability studies.

You will troubleshoot instruments, ensure GxP data integrity per 21 CFR Part 11, train lab personnel, and collaborate with R&D, Manufacturing, and Quality teams to define material specifications and acceptance criteria.

Formación

• B.S. in Chemistry, Biochemistry, Chemical Engineering, or related field.
• Min 2 years of hands-on HPLC/analytical lab experience in a regulated environment (GxP, FDA, or ISO 13485).
• Experience with method development, qualification, validation, and troubleshooting.

Responsabilidades

• Develop, validate, and transfer HPLC methods for raw materials, in-process, and finished reagents.
• Perform routine HPLC and other analytical instrumentation testing to support batch release and stability studies.
• Prepare analytical standards for use in HPLC analyses.
• Troubleshoot chromatographic and instrument issues to minimize downtime.
• Write and revise analytical test methods and SOPs; support method validation protocols.
• Support method transfer, development, and equipment validation activities for new products.

Conocimientos

HPLC

Analytical chemistry

GxP compliance

Data analysis

Laboratory troubleshooting

Educación

B.S. in Chemistry, Biochemistry, Chemical Engineering, or related field

Herramientas

Empower

Chromeleon

Descripción del empleo

Pattern Bioscience is seeking an Analytical Chemist to join our Consumable Manufacturing team in Austin. You will develop, validate, and transfer HPLC methods for raw materials, in-process samples, and finished reagents to support batch release and stability studies.

You will troubleshoot instruments, ensure GxP data integrity per 21 CFR Part 11, train lab personnel, and collaborate with R&D, Manufacturing, and Quality teams to define material specifications and acceptance criteria.