HPLC Lead Scientist — GMP QC & Analytics

Celgard; Fremont (CA); On-site; USD 140,000 - 170,000; Full time

Job summary

Bionova Scientific LLC in Fremont, CA, is seeking a Sr. Scientist HPLC Lead to support efficient, compliant QC operations in a regulated GMP environment. You will focus on HPLC and Empower CDS, author validation documents, and drive QA improvements while leading a team of analysts.

The role requires deep HPLC/CE expertise, CDS workflow design, and strong GMP familiarity, with leadership responsibilities across global teams and audits.

Qualifications

• Bachelor of Science degree in a scientific field.
• 8–10+ years in analytical or quality control environments; 3+ years GMP Quality Control Laboratory.
• Strong working knowledge of HPLC and CE analytics with GMP validation experience.
• Experience designing CDS workflows (data review, audit trails, design of workflows).
• Excellent written and verbal communication skills; GMP knowledge.
• Familiarity with GMP regulations (21 CFR, ICH, Eudralex).

Responsibilities

• Serve as an HPLC SME and drive improvements to HPLC workflows and Empower CDS.
• Author and maintain analytical methods, validation and qualification docs and lab procedures.
• Prepare validation/qualification documents for new methods/equipment or training junior staff.
• Support troubleshooting and transfer tests from Analytical Development to GMP operations.
• Review data to identify trends, assess risk, and initiate corrective actions.
• Lead investigations for deviations (OOS/OOT/OOR/OOE) and define CAPAs.
• Represent QC processes during client audits and regulatory inspections.
• Implement Lean lab practices and continuous improvement for efficiency.
• Provide cross-trained resources to address urgent analytical needs.

Skills

HPLC

CE analytics

GMP knowledge

Data analysis

CDS workflows

GMP software

Education

B.S. in a scientific field

Tools

LIMS

Empower

Job description

Bionova Scientific LLC in Fremont, CA, is seeking a Sr. Scientist HPLC Lead to support efficient, compliant QC operations in a regulated GMP environment. You will focus on HPLC and Empower CDS, author validation documents, and drive QA improvements while leading a team of analysts.

The role requires deep HPLC/CE expertise, CDS workflow design, and strong GMP familiarity, with leadership responsibilities across global teams and audits.