Senior Analytical Operations Lead (Remote/Hybrid)

BridgeBio Inc.; San Francisco, Northern (CA, KY); Hybrid; USD 130,000 - 160,000; Full time

Benefits offered by this job

Market-leading compensation

401(k) with employer match

Employee Stock Purchase Program (ESPP)

Pre-tax commuter benefits

Hybrid work model

100% employer-paid medical, dental, &

Job summary

BridgeBio seeks a seasoned Analytical Development and QC leader to manage development, QC activities, and stability programs at contract sites, collaborating with Drug Substance, Drug Product, and QA groups. You will author and review CMC sections for US and international filings and drive method validation and transfer.

The role requires deep cGMP/ICH knowledge, strong communication with vendors, and the ability to travel. Remote/hybrid with SF office visits as needed.

Qualifications

• 10+ years of experience in Analytical Development and/or Quality Control in pharma.
• Familiarity with CMC analytical regulatory requirements and IND/IMPD/BLA/NDA/MAA filings.
• Proficient in multiple analytical techniques for biologics and small molecules.
• Experience with cGMPs, USP and ICH guidelines and QA interactions.

Responsibilities

• Manage contract drug substance and drug product analytical development, QC activities and timelines.
• Review analytical method transfer documentation and validation reports.
• Review stability protocols and monitor stability program.
• Author and approve analytical technical reports and CMC sections for filings.
• Collaborate with QA to close investigations and deviations.
• Manage reference standards and reagents programs across CDMOs.
• Direct batch release support, review sampling plans and CoAs/CoTs.
• Lead change controls and CAPAs with root cause analysis.

Skills

Analytical Development

Quality Control

Regulatory filings (IND/IMPD/BLA/NDA//

cGMPs/USP/ICH

Stability program management

Vendor management

Data analysis (JMP)

Cross-functional collaboration

Tools

Veeva Vault

TrackWise

LIMS

JMP

Job description

BridgeBio seeks a seasoned Analytical Development and QC leader to manage development, QC activities, and stability programs at contract sites, collaborating with Drug Substance, Drug Product, and QA groups. You will author and review CMC sections for US and international filings and drive method validation and transfer.

The role requires deep cGMP/ICH knowledge, strong communication with vendors, and the ability to travel. Remote/hybrid with SF office visits as needed.