Senior Analytical Development Manager - QC & Validation

BridgeBio; San Francisco (CA); Hybrid; USD 153,000 - 185,000; Full time

Benefits offered by this job

Hybrid work model with flexibility

100% employer-paid medical, dental, &

Vision premiums for dependents

Job summary

BridgeBio seeks a senior Analytical Development and QC professional to lead analytical development, QC activities, and stability programs across contract sites. This role collaborates with Drug Substance, Drug Product, and QA, applying broad analytical techniques and strong regulatory knowledge.

The candidate will author transfer/validation docs, support batch release, manage stability data, and contribute to US and international regulatory filings, while ensuring cGMP compliance and effective

Qualifications

• At least 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.
• Independently proficient with a variety of analytical techniques for biologics and small molecules.
• Strong communication with vendors on scope, results, and timelines.
• Thorough understanding of cGMPs, USP and ICH guidelines.
• Stability program management knowledge including protocol design, data trends and shelf-life decisions.
• Proficiency with enterprise quality systems (Veeva, TrackWise, LIMS).
• Ability to adapt priorities and make decisions under tight timelines.
• 5–15% travel with international travel capability.

Responsibilities

• Manage contract drug substance and drug product analytical development and QC activities and timelines.
• Author and review transfer/validation protocols and reports.
• Support direct batch release by reviewing sampling plans and analytical data; generate CoAs/CoTs and specifications.
• Review stability protocols and monitor stability programs.
• Prepare CMC sections for US and ex-US regulatory filings.
• Collaborate with QA to manage change controls; lead OOS/OOT investigations and CAPA.
• Develop, revise, and approve QC SOPs and processes for compliance and efficiency.

Skills

Analytical development

Quality control

Stability program management

cGMPs

ICH guidelines

JMP

Veeva Vault

TrackWise

LIMS

Tools

JMP

Veeva Vault

TrackWise

LIMS

Job description

BridgeBio seeks a senior Analytical Development and QC professional to lead analytical development, QC activities, and stability programs across contract sites. This role collaborates with Drug Substance, Drug Product, and QA, applying broad analytical techniques and strong regulatory knowledge.

The candidate will author transfer/validation docs, support batch release, manage stability data, and contribute to US and international regulatory filings, while ensuring cGMP compliance and effective