Hybrid Senior Analytical Development Leader

BridgeBio Pharma; Owens (OH); Hybrid; USD 153,000 - 185,000; Full time

Benefits offered by this job

401(k) with employer match

Employee Stock Purchase Program (ESPP)

Pre-tax commuter benefits (transit and

parking)

Referral bonus for hired candidates

Subsidized lunch and parking on in‑off

office days

Job summary

BridgeBio seeks a motivated analytical development scientist and quality control professional to lead analytical development, QC, and stability activities at contract sites, partnering with Drug Substance, Drug Product, and QA teams.

This role requires expertise across modalities, method development and transfer, and phase-appropriate validation, with strong communication and regulatory submission experience.

Qualifications

• 10+ years of experience in Analytical Development and/or Quality Control in a pharmaceutical setting.
• Familiarity with CMC analytical regulatory requirements and authoring IND/IMPD/BLA/NDA/MAA filings.
• Independent proficiency in analytical techniques for biologics and small molecules.
• Strong communication with vendors, timelines, and prioritization.
• Thorough understanding of cGMPs, USP and ICH guidelines, and industry best practices.

Responsibilities

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

Skills

Analytical Development

Quality Control

Stability program management

cGMPs

ICH guidelines

JMP

Veeva Vault

TrackWise

LIMS

Regulatory filings

Tools

JMP

Veeva Vault

TrackWise

LIMS

Job description

BridgeBio seeks a motivated analytical development scientist and quality control professional to lead analytical development, QC, and stability activities at contract sites, partnering with Drug Substance, Drug Product, and QA teams.

This role requires expertise across modalities, method development and transfer, and phase-appropriate validation, with strong communication and regulatory submission experience.