Senior Analytics & QC Leader — Remote Biopharma

BridgeBio; United States; Hybrid; USD 130,000 - 160,000; Full time

Benefits offered by this job

401(k) with employer match

Employee Stock Purchase Program (ESPP)

Hybrid work model with flexibility

Comprehensive health benefits

Job summary

BridgeBio seeks an experienced analytical development and quality control professional to lead analytical development, QC, and stability activities at contract sites, collaborating with Drug Substance, Drug Product, and QA groups. You will oversee method transfer, validation, and stability programs while ensuring compliance with ICH, USP, and cGMP standards.

The role requires strong communication skills, vendor coordination, and the ability to adapt to shifting priorities with tight timelines.

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 IND/IMPD/BLA/MAA filings.
• Proficient with GMPs, USP and ICH guidelines; strong stability program knowledge.

Responsibilities

• Manage contract drug substance and drug product analytical development and QC activities and timelines.
• Review analytical method transfer documentation.
• Review validation protocols and reports.
• Review stability protocols and monitor the stability program.
• Author, review, and approve analytical technical reports.
• Adjudicate CMC sections for US and ex-US regulatory filings.

Skills

Analytical development

Quality control

Method validation

Data analysis

Communication

Tools

Veeva Vault

TrackWise

LIMS

JMP

Job description

BridgeBio seeks an experienced analytical development and quality control professional to lead analytical development, QC, and stability activities at contract sites, collaborating with Drug Substance, Drug Product, and QA groups. You will oversee method transfer, validation, and stability programs while ensuring compliance with ICH, USP, and cGMP standards.

The role requires strong communication skills, vendor coordination, and the ability to adapt to shifting priorities with tight timelines.