Sr. Specialist QC / Sr. Scientist QC

Bionova is a rapidly growing biologics CDMO focused on developing and manufacturing recombinant protein products using mammalian cell culture processes. Our success is built on bringing together top scientific talent, equipping them with the best tools, and fostering an agile, energized culture dedicated to solving complex client challenges. As a subsidiary of Asahi Kasei Medical, we leverage the strength of the Asahi Kasei Group to accelerate growth and expand our service offerings.

About the role

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

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.
• Serve as subject matter expert 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 enhance assay robustness, laboratory efficiency, testing continuity, right-first-time execution, and inspection readiness.

Requirements

• 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.

Working Conditions

This position requires work in a lab/office setting. The role involves walking, standing, stooping, kneeling, and crouching. The employee must occasionally lift and/or move up to 20 pounds independently.

Pay

The base compensation range for this role is $113,000 – $150,000 (salary). Base compensation is influenced by factors including time in the role, previous experience, skills, knowledge, performance, work requirements, internal equity, and business/economic conditions.