Senior Analytical Development Leader — Hybrid

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

Benefits offered by this job

Market-leading compensation

401(k) with employer match

Employee Stock Purchase Program (ESPP)

Pre-tax commuter benefits

Health insurance for you and dependet

Job summary

BridgeBio Pharma seeks an experienced Manager/Sr. Manager, Analytical Development to lead analytical development, QC, and stability activities across sites and support regulatory filings.

The role requires collaboration with Drug Substance, Drug Product, and QA teams to ensure robust method transfer, validation, and data analysis. The candidate will oversee method transfer, batch release support, and CAPA-driven improvements while navigating cGMPs, USP, and ICH guidelines.

Qualifications

• At least 10 years of experience in Analytical Development and/or Quality Control in a pharmaceutical setting.
• Familiarity with CMC analytical regulatory requirements and authoring of IND/IMPD/BLA/NDA/MAA filings and responses to regulatory inquiries.
• Independently proficient in a variety of analytical techniques in support of biologic and small molecule development.
• Ability to communicate effectively with vendors regarding project scope, scientific results and project updates; prioritize activities to achieve goals.
• Thorough understanding of cGMPs, USP and ICH guidelines, and industry best practices.
• Subject matter expertise in stability program management, including protocol design, data trending and analysis (e.g., using JMP).
• Proficient with enterprise quality management systems such as Veeva Vault, TrackWise, and LIMS.

Responsibilities

• Management of contract drug substance and drug product analytical development and quality control activities and timelines
• Authoring and review of analytical method transfer and validation protocols and reports
• Direct batch release support by reviewing and approving sampling plans and analytical data; generate and maintain CoAs, CoTs, and product specifications
• Review stability protocols and monitor various stability programs
• Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings
• Partner with QA to manage change controls; lead OOS/OOT and deviation investigations to identify root causes and implement CAPAs
• Develop, revise, and approve SOPs and QC processes, enhancing compliance, consistency, and operational efficiency

Skills

Analytical Development

Quality Control

Stability Program Management

cGMPs & ICH

Regulatory Filings

Vendor Communication

JMP Analysis

Tools

Veeva Vault

TrackWise

LIMS

Job description

BridgeBio Pharma seeks an experienced Manager/Sr. Manager, Analytical Development to lead analytical development, QC, and stability activities across sites and support regulatory filings.

The role requires collaboration with Drug Substance, Drug Product, and QA teams to ensure robust method transfer, validation, and data analysis. The candidate will oversee method transfer, batch release support, and CAPA-driven improvements while navigating cGMPs, USP, and ICH guidelines.