Remote Director, Analytical Development (Biopharma)

BridgeBio Inc.; Northern (KY); Hybrid; 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)

Pre-tax commuter benefits (transit and

parking

Referral bonus

Subsidized lunch and parking

Employer-paid medical, dental, and视/v?

Job summary

BridgeBio Inc. is seeking an experienced analytical chemist to lead development and tracking of testing methods for drug substance and product. You will collaborate with internal teams and CRO/CMO partners to advance programs toward regulatory milestones.

The role requires an MS in relevant chemistry fields and 5+ years in pharma/biotech, with expertise in HPLC, cGMP, and analytical method validation. This position offers a remote work model with 30% travel and a strong benefits package.

Qualifications

• MS in Organic Chemistry, Analytical Chemistry, Pharmaceutical Science required.
• 5+ years’ experience in contract research or pharmaceutical/biotech industry.
• Experience with analytical assay development and validation.
• Knowledge of cGMP regulations and USP/EP/JP guidance.

Responsibilities

• Manage the development and tracking of stage-appropriate testing methods for drug substance and drug product.
• Coordinate with internal Analytical, CMC, QA, Regulatory, Project Management and CRO/CMO counterparts.
• Review SOPs, test methods, specifications for materials and products, development/verification reports, validation protocols/reports, method transfers, COAs and stability summaries.
• Support contractor site investigations pertaining to OOS/OOT and deviations.
• Assist in data generation and analysis.
• Ensure analytical development activities are aligned with the project’s objectives.
• Assist in regulatory filings.
• Perform data review & stability tracking.

Skills

Analytical assay development

Impurity analysis

In vitro dissolution release

HPLC

Physicochemical properties

Methods development

Drug substance

Drug product

cGMP regulations

FDA/EMA/ICH guidance

Education

MS in Organic Chemistry, Analytical Chemistry, Pharmaceutical Science

Job description

BridgeBio Inc. is seeking an experienced analytical chemist to lead development and tracking of testing methods for drug substance and product. You will collaborate with internal teams and CRO/CMO partners to advance programs toward regulatory milestones.

The role requires an MS in relevant chemistry fields and 5+ years in pharma/biotech, with expertise in HPLC, cGMP, and analytical method validation. This position offers a remote work model with 30% travel and a strong benefits package.