Sr. Specialist QC / Sr. Scientist QC

Bionova Scientific; Fremont (CA); On-site; USD 113,000 - 150,000; Full time

Job summary

Bionova Scientific LLC in Fremont, California seeks an experienced QC Sr. Specialist/Scientist to provide advanced analytical leadership, hands-on support, and coaching for complex assays in a GMP environment.

The role includes guiding method qualification/validation, data review, and troubleshooting to ensure robust QC delivery and patient-focused outcomes.

Qualifications

• BS in Biological Sciences or related discipline with 5–7 years of bioassay and/or ELISA experience in a regulated QC GMP environment.
• Hands-on expertise with bioassay, ELISA, qPCR, SpectraMax and QuantStudio platforms, including method validation and troubleshooting.
• Strong understanding of GMP, GDP, Data Integrity, ALCOA+, and global regulatory guidelines.
• Ability to interpret SOPs, review complex data, and communicate scientifically justified conclusions.

Responsibilities

• Provide senior-level technical oversight and hands-on execution support for cell-based assays, ELISA, and qPCR testing in GMP.
• Coach analysts on GMP documentation, data review, assay execution, and scientific rationale to build capability.
• Lead complex troubleshooting for assay performance, instrumentation, and laboratory readiness.
• Support deviations, CAPAs, change controls, regulatory inspections, and observation responses with clear analysis.
• Identify and lead continuous improvement initiatives to improve assay robustness and inspection readiness.

Skills

Bioassay experience

ELISA experience

qPCR experience

Technical leadership

Education

BS in Biological Sciences or related

Tools

SpectraMax

QuantStudio

Job description

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 contributor, coach less experienced analysts, influence cross‑functional teams, and drive complex issues to resolution.
• Effective verbal and written communication skills, with proficiency in Microsoft Office Suite.

The base compensation range for this role is $113,000 – $150,000 (salary). 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.

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.