Process Development Associate

What You Will Do

In this vital role you will transform the lives of patients while transforming your career:

• Execute routine and moderately complex laboratory studies, under general direction, to support analytical method qualification, transfer, and testing of biopharmaceutical samples.
• Perform accurate sample and reagent preparation and operate analytical technologies such as HPLC/UPLC, UV-visible spectrophotometry, and general wet-chemistry assays in accordance with approved procedures and safety requirements.
• Generate, calculate, review, and document data using strong data-integrity and Good Documentation Practices.
• Contribute to experiment records, qualification summaries, technical reports, analytical methods, and related controlled deliverables.
• Support routine and time-sensitive testing, prioritizing work across concurrent requests to meet agreed timelines.

Basic Qualifications

• Bachelor's degree or Associates degree and 2 years of operations experience or High school diploma/GED and 4 years of operations experience.

Preferred Qualifications

• Laboratory experience in analytical testing, process development, Quality Control, or biopharmaceutical development, including sample and reagent preparation and execution against written procedures.
• Hands-on experience with HPLC or UPLC; exposure to charged aerosol detection, UV/visible spectrophotometry, and/or wet-chemistry assays.
• Familiarity with protein formulations and surfactants such as polysorbate.
• Working knowledge of Good Documentation Practices, data integrity, and regulated laboratory systems; experience with chromatography data systems, electronic laboratory notebooks, and/or controlled-document workflows.
• Demonstrated ability to perform calculations, recognize atypical results, troubleshoot with guidance, manage multiple priorities, communicate clearly, and deliver high-quality work in a collaborative environment.