Senior Manager, Analytical Development & QC (Remote)

BridgeBio Pharma; United States; 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

Referral bonus

Subsidized lunch and parking

Comprehensive medical, dental and VISN

Hybrid work model

Job summary

BridgeBio seeks a motivated analytical development scientist and quality control professional to manage analytical development, QC, and stability activities at contract manufacturing sites and to contribute to regulatory submissions. This position requires collaboration with Drug Substance, Drug Product, and Quality Assurance groups.

This role demands 10+ years in Analytical Development/Quality Control, familiarity with cGMPs/ICH, and proficiency with JMP, Veeva Vault, TrackWise, and LIMS; 5-15%

Qualifications

• 10+ years in Analytical Development and/or Quality Control in a pharmaceutical setting.
• Familiarity with CMC analytical regulatory requirements and IND/IMPD/BLA/NDA/MAA filings.
• Proficient in analytical techniques for biologic and small molecule development.
• Strong communication with vendors; manage project timelines and updates.
• Thorough understanding of cGMP, USP, ICH guidelines and industry best practices.
• Stability program management, data trending (JMP) and shelf-life assignment.
• Experience with QA to close investigations and deviations; CAPA leadership.
• Proficient with QA systems such as Veeva Vault, TrackWise, and LIMS.

Responsibilities

• Manage contract drug substance and drug product analytical development and QC activities.
• Review analytical method transfer documentation and validation protocols/reports.
• Review stability protocols and monitor stability program.
• Author, review, and approve analytical technical reports.
• Author, review, and adjudicate CMC sections for US and ex-US filings.
• Collaborate with QA to close investigations and deviations.
• Manage reference standards and critical reagents programs across CDMOs.
• Direct batch release support by reviewing sampling plans and data; generate CoAs/CoTs.
• Partner with QA to manage change controls; lead OOS/OOT investigations and CAPAs.
• Develop, revise, and approve SOPs and QC processes to improve compliance.

Skills

Analytical Development

Quality Control

Stability Program Management

cGMPs

ICH Guidelines

JMP

Veeva Vault

TrackWise

LIMS

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

Tools

JMP

Veeva Vault

TrackWise

LIMS

Job description

BridgeBio seeks a motivated analytical development scientist and quality control professional to manage analytical development, QC, and stability activities at contract manufacturing sites and to contribute to regulatory submissions. This position requires collaboration with Drug Substance, Drug Product, and Quality Assurance groups.

This role demands 10+ years in Analytical Development/Quality Control, familiarity with cGMPs/ICH, and proficiency with JMP, Veeva Vault, TrackWise, and LIMS; 5-15%