QC Analyst

Asahi Kasei•The Woodlands, TX

3d•Onsite

About The Position

Bionova, a subsidiary of Asahi Kasei Medical, is a rapidly growing biologics CDMO specializing in the development and manufacturing of recombinant protein products and Plasmid DNA using mammalian cell culture processes. We are seeking a full-time, direct-hire QC Analyst to support analytical testing activities, including method transfer, verification, and qualification. The role involves ensuring all work adheres to established procedures, protocols, and regulatory requirements, with close collaboration with the Lead QC Specialist, Manufacturing teams, and the Analytical Development group. This position requires cross-functional work across the site and interaction with Bionova clients to ensure accurate, reliable, and timely laboratory results.

Requirements

Bachelor of Science degree or equivalent in a scientific field (chemistry, biology, etc.)
1-3 years of GMP Quality Control Laboratory experience including instrument qualification, testing, method transfer, etc.
Hands-on experience with molecular biology or analytical techniques (e.g., UV/Vis, gel electrophoresis, endotoxin testing, PCR,)
Understanding of cGMP regulations and quality standards
Proficiency in data analysis, statistical methods, and scientific writing
Excellent communication and collaboration skills to work effectively with cross-functional teams

Nice To Haves

Experience with UPLC and ELISA is preferred

Responsibilities

Support the team in the transfer of analytical methods, ensuring accuracy, compliance with regulatory standards, and smooth transition of testing procedures.
Execute method transfer protocols, including method comparison studies, data analysis, and documentation to verify the accuracy and precision of analytical methods in the new laboratory.
Maintain complete, accurate, and compliant records in accordance with GMP, GDP, and regulatory guidelines.
Understand analytical techniques relevant to the release of plasmid DNA (e.g., HPLC, PCR, ELISA, Agarose Gel Electrophoresis), regulatory requirements (cGMP), and quality standards.
Work closely with development scientists, manufacturing personnel, and quality assurance teams to facilitate a seamless method transfer process.
Assist in drafting and reviewing test methods, protocols, SOPs, and data reports.
Maintain laboratory inventory, reagents, and consumables to support uninterrupted testing operations.