Sr. Specialist QC / Sr. Scientist QC

As a senior member of the growing QC team, this role will help guide and execute complex assay work, coach and develop analysts, lead troubleshooting efforts, and contribute to robust technical solutions that support project delivery and ultimately improve patient outcomes. Essential Duties and Responsibilities: Provide senior-level technical oversight and hands-on execution support for cell-based assays, ELISA, and qPCR testing, including method qualification, validation, transfer, release, in-process, and stability support in a GMP environment.

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:
Bionova Scientific LLC

Job Description:

Bionova is seeking an experienced and technically strong QC Sr. Specialist / Scientist to provide advanced analytical expertise, hands-on laboratory support, and scientific leadership in support of our expanding business. As a senior member of the growing QC team, this role will help guide and execute complex assay work, coach and develop analysts, lead troubleshooting efforts, and contribute to robust technical solutions that support project delivery and ultimately improve patient outcomes.

Location: Fremont, California

Bionova B1 building 3100 W. Warren ave, Fremont, CA 94538

Direct hire - Full Time

Company Summary:

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.

Essential Duties and Responsibilities:

• Provide senior-level technical oversight and hands-on execution support for cell-based assays, ELISA, and qPCR testing, including method qualification, validation, transfer, release, in-process, and stability support in a GMP environment.
• Provide subject matter expertise for analytical methods, SOPs, protocols, technical assessments, and QC documentation to ensure scientifically sound and compliant execution.
• Coach analysts on GMP documentation, data review, assay execution, and scientific rationale to build technical capability and strengthen compliance within the QC team.
• Lead complex troubleshooting for assay performance, instrumentation, invalid results, atypical trends, equipment issues, and laboratory readiness.
• Support deviations, CAPAs, change controls, regulatory inspections, and observation responses with clear technical analysis, defensible conclusions, and practical remediation strategies.
• Identify and lead continuous improvement initiatives to improve assay robustness, laboratory efficiency, testing continuity, right-first-time execution, and inspection readiness.

Working Conditions:

• This position required to 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 20 pounds independently.

Qualifications:

• BS in Biological Sciences or related discipline with 5-7 years of bioassay and/or ELISA experience, including 3-5 years in a regulated QC GMP laboratory environment.
• Strong hands-on expertise with bioassay, ELISA, qPCR, SpectraMax, and QuantStudio platforms, including method validation, transfer, technical investigations, and troubleshooting.
• Strong understanding of GMP, GDP, Data Integrity, ALCOA+, global regulatory guidelines, and quality systems including deviations, CAPA, and change control.
• Ability to interpret SOPs, protocols, regulatory requirements, and complex data; recognize trends; develop scientifically justified conclusions; and communicate recommendations clearly.
• Demonstrated ability to work independently as a senior technical contribu