Lead HPLC Scientist - GMP QC & Empower Expert

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

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.