Asahi Kasei
Bionova Scientific Llc
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. Position Summary
This individual contributor position, reporting to the QC Analyst, is responsible for supporting analytical testing activities related to method transfer, verification, and qualification. The QC Associate 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 Associate 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. 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). 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 Bionova offers health benefits at a subsidized rate. Healthcare, Dental, and Vision insurance Life Insurance and Disability Program: 100% covered by Bionova. Retirement Plan (401K) Up to 8% of Employer Match Paid time off up to two weeks 10 days of Holidays and 5 days of Sick Leave.
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. Position Summary
This individual contributor position, reporting to the QC Analyst, is responsible for supporting analytical testing activities related to method transfer, verification, and qualification. The QC Associate 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 Associate 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. 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). 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 Bionova offers health benefits at a subsidized rate. Healthcare, Dental, and Vision insurance Life Insurance and Disability Program: 100% covered by Bionova. Retirement Plan (401K) Up to 8% of Employer Match Paid time off up to two weeks 10 days of Holidays and 5 days of Sick Leave.