QC Analyst

The Asahi Kasei Group operates with a commitment of creating for tomorrow.  Our business sectors, Material, Homes, and Health Care, contribute to the development of society by anticipating the changing needs of those around the world. We look for candidates that offer a fresh perspective and a variety of skills to help us achieve our commitment.

Bionova is a rapidly growing, biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems. Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability and an interest in transformative action are also common attributes among our team. Bionova became a subsidiary of Asahi Kasei Medical in May 2022, a division of Tokyo-based Asahi Kasei Group. This acquisition has enabled Bionova to greatly accelerate growth of the business, both in capacity of current service offerings and expansion into new service offerings.

Company:

Job Description:

We are seeking a full time direct hire QC Analyst to report to the QC Manager. You will be responsible for supporting analytical testing activities related to method transfer, verification, and qualification. The QC Analyst ensures all work is executed in accordance with established procedures, protocols, and regulatory requirements. This role requires close collaboration with the Lead QC Specialist, Manufacturing teams, and scientists within the Analytical Development group. Additionally, the QC Analyst will work cross-functionally across the site and interface with Bionova clients to ensure that laboratory results are accurate, reliable, and delivered in a timely manner.

Location: Bionova in The Woodlands, TX

2635 Technology Forest Blvd, The Woodlands, TX 77381

Position Responsibilities:

• Support the team in the transfer of analytical methods, ensuring accuracy, compliance with regulatory standards, and smooth transition of testing procedures.
• Executing 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.
• Understanding of analytical techniques relevant to the release of plasmid DNA (e.g., HPLC, PCR, ELISA, Agarose Gel Electrophoresis), regulatory requirements (cGMP), and quality standards.
• Working closely with development scientists, manufacturing personnel, and quality assurance teams to facilitate 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.

Working Conditions:

This position requires work in a lab/office setting. The role requires walking, standing, stooping, kneeling, and crouching.  The employee must occasionally lift and or move up to 15 pounds independently.

Qualifications:

• 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,)
• Experience with UPLC and ELISA is preferred
• 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 

The base compensation range for this role is $65,000-$80,000. Base Compensation is influenced by many factors including, but not limited to: time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business / economic conditions.

Company Summary:

Bionova is a rapidly growing biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes and Plasmid DNA isolated from recombinant microbial cell culture. Our business success is built on bringing together top scientific talent, arming them with the best available tools, and setting them loose in an agile, energized culture focused on solving difficult client problems.

Because our success depends on our ability to exceed our clients’ expectations, we look for candidates with an innate desire to serve. Adaptability, agility and an interest in transformative action are also common attributes among our team.

#LI-MG1

As an equal opportunity employer, Asahi Kasei believes a diverse workforce will provide us with the ability to continuously support the changes in the economy, society, and environment.