Lead, Analytical Development – Remote Role

Visa Hunt; United States; On-site; USD 144,000 - 159,000; Full time

Benefits offered by this job

Market-leading compensation

401(k) with employer match

Employee Stock Purchase Program (ESPP)

Hybrid work model

Health benefits

Job summary

BridgeBio in California seeks an experienced Analytical Scientist to lead development and tracking of testing methodologies for drug substance and drug product, including in-process, release, stability, method validation and site transfer under aggressive timelines.

You will collaborate with internal Analytical, CMC, QA, Regulatory, Project Management and CRO/CMOs to advance programs, review SOPs and stability summaries, and support regulatory filings under US guidelines.

Qualifications

• MS in Organic Chemistry, Analytical Chemistry, or Pharmaceutical Science.
• 5+ years in CRO or pharma/biotech.
• Experience with analytical assays, impurities, and in-vitro release.
• Knowledge of cGMP, USP/EP/JP, FDA/EMA/ICH guidelines.
• Experience with HPLC and physicochemical properties.

Responsibilities

• Develop and manage testing methodologies for drug substance and product.
• Coordinate with Analytical, CMC, QA, Regulatory, and CROs/CMOs.
• Review SOPs, test methods, specifications, and stability summaries.
• Support investigations of OOS/OOT and deviations.
• Assist in regulatory filings and data generation.

Skills

Analytical Chemistry

HPLC

Regulatory knowledge

Quality & QA

Project coordination

Education

MS in Organic Chemistry

Tools

HPLC

cGMP

Job description

BridgeBio in California seeks an experienced Analytical Scientist to lead development and tracking of testing methodologies for drug substance and drug product, including in-process, release, stability, method validation and site transfer under aggressive timelines.

You will collaborate with internal Analytical, CMC, QA, Regulatory, Project Management and CRO/CMOs to advance programs, review SOPs and stability summaries, and support regulatory filings under US guidelines.