Sr. Scientist HPLC Lead

Bionova Scientific LLC; United States; On-site; USD 140,000 - 170,000; Full time

Job summary

Bionova Scientific LLC, a rapidly growing biologics CDMO, seeks a Sr. Scientist HPLC Lead to optimize HPLC workflows in a GMP environment and lead a QC team in Fremont, CA. You will develop methods, supervise validations, and ensure CDS systems (Empower/LIMS) support compliant operations.

Responsibilities include method development, QC investigations, audits support, and driving continuous improvement in analytical quality and efficiency.

Qualifications

• Bachelor of Science degree in a scientific field.
• 8–10+ years of experience in analytical or quality control environments.
• Minimum of 3 years of GMP Quality Control Laboratory experience.
• Strong working knowledge of HPLC and CE analytics with GMP validation.
• Experience in designing CDS workflows (data review, audit trails, design workflows).
• Expertise in data analysis, trend analysis, and statistics.
• Excellent written and verbal communication skills; GMP software experience (LIMS, Empower).
• Knowledge of GMP regulations and guidance (21 CFR, ICH, Eudralex).
• Strong organizational and planning skills; ability to handle change.

Responsibilities

• Serve as an HPLC SME; drive improvements to HPLC workflows and Empower CDS.
• Author and maintain analytical methods, validation and qualification docs and related procedures.
• Develop analytical procedures and validation/qualification documents for new methods/equipment; mentor junior QC staff.
• Support troubleshooting and transfer tests from Analytical Development to GMP operations.
• Review analytical data to identify trends, assess risk, and initiate CAPAs.
• Lead deviations investigations (OOS/OOT/OOR/OOE) with root-cause analysis.
• Represent QC in client audits and regulatory inspections; ensure QC processes compliance.
• Implement Lean practices; drive continuous improvement in lab efficiency.
• Provide cross-functional support by cross-training QC staff.

Skills

HPLC Expertise

CE Analytics

GMP Knowledge

Data Analysis

Technical Writing

LIMS

Empower CDS

Education

Bachelor of Science in a scientific field

8–10+ years in analytical/QC environments

Tools

Empower CDS/ CDS software

LIMS

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:

Partnering closely with the Senior Director of Quality Control, the Sr. Scientist HPLC Lead will help support the establishing efficient, compliant, and high-performing laboratory operations with a focus on HPLC and CE in a regulated GMP environment. This role requires deep expertise in all aspects of HPLC testing and a sound understanding in CDS software, preferably Empower, Quality Control GMP operations and quality systems, along with demonstrated leadership capability and the ability to effectively influence teams and stakeholders across organizational and global environments.

Location:

Fremont, CA

Position Responsibilities:

• Serve as an HPLC subject matter expert and drive improvement of HPLC workflows and our Empower based CDS.
• Author and maintain analytical methods, validation and qualification documentation, and relevant laboratory procedures.
• Authoring analytical procedures and their associated validation and qualification documents for new analytical testing methods or equipment or training and mentoring junior QC team members therein
• Support troubleshooting and transfer tests from Analytical Development into GMP operations.
• Review and interpret analytical data to identify trends, assess risk, and initiate appropriate corrective actions.
• Lead investigations for deviations, including OOS, OOT, OOR, and OOE, performing root cause analysis and defining corrective and preventive actions.
• Act as a subject matter expert during client audits and regulatory inspections, representing QC analytical and operational processes.
• Implement Lean laboratory practices and drive continuous improvement to enhance efficiency and performance.
• Support cross-functional QC activities by providing cross-trained resources to address urgent analytical needs.
• Lead, coach, and develop a team of analysts to ensure high technical and performance standards.
• Establish and maintain compliant laboratory operations aligned with Bionova quality standards and regulatory requirements, including the definition and monitoring of key performance indicators.

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 20 pounds independently.

Qualifications:

• Bachelor of Science degree or equivalent in a scientific field
• Minimum of 8-10+ years of experience in analytical or quality control environments.
• Minimum of 3 years of GMP Quality Control Laboratory.
• Strong working knowledge of HPLC and CE analytics with expertise in method development and GMP validation.
• Experience in designing CDS workflows (data review, audit trails, design of workflows, custom fields…)
• Expertise in data analysis, trend analysis, and statistical methods.
• Excellent written and verbal communication skills to effectively document findings and present technical information.
• Working knowledge of GMP regulations and guidance (21 CFR, ICH, Eudralex etc.)
• Effective organization and planning skills.
• Demonstrated ability to deal with frequent changes, delays, or unexpected events
• Strong technical writing skills and expertise with GMP software (e.g. LIMS, Empower, or equivalent systems)
• Effective interpersonal and communication skills.
• Communication at all management levels and all staff is required.

Base Compensation:

The base compensation range for this role is $140,000-$170,000. 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. #LI-MG1

Equal Opportunity Statement:

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.