Lead, Analytical Development & QC (Hybrid)

BridgeBio Inc.; San Francisco, Northern (CA, KY); Hybrid; USD 153,000 - 185,000; Full time

Benefits offered by this job

Market-leading compensation

401(k) with employer match

Employee Stock Purchase Program (ESPP)

Hybrid work model

100% employer-paid medical premiums

Job summary

BridgeBio seeks a Manager/Sr. Manager, Analytical Development in San Francisco for a hybrid role leading analytical development, QC, and stability activities at contract manufacturing sites and contributing to clinical asset development and regulatory submissions.

The position requires 10+ years in Analytical Development/Quality Control in pharma, knowledge of cGMP, USP and ICH guidelines, and experience with regulatory filings. Expect travel up to 15%.

Qualifications

• Familiarity with CMC analytical regulatory requirements and IND/IMPD/BLA/NDA/MAA filings responses
• Independently proficient in analytical techniques for biologic and small molecule development
• Excellent communication with vendors on scope, results and updates
• Thorough understanding of cGMPs, USP and ICH guidelines
• Stability program management experience incl. protocol design and data trending (JMP)
• Proficient with QMS like Veeva Vault, TrackWise, and LIMS
• Ability to adapt priorities and make decisions under tight timelines
• Travel readiness (5-15%) and intl travel requirement

Responsibilities

• Manage analytical development and QC activities at CROs/sites
• Author and review transfer and validation protocols/reports
• Support batch release with sampling plans, CoAs/CoTs and specs
• Review stability protocols and monitor stability programs
• Contribute CMC sections for US and ex-US filings
• Partner with QA to manage change controls; investigate OOS/OOT deviations
• Develop and approve SOPs and QC processes to enhance compliance and efficiency

Skills

CMC knowledge

Analytical techniques

Vendor communication

Regulatory guidelines

Stability program mgmt

QMS tools

Decision making

Travel readiness

Job description

BridgeBio seeks a Manager/Sr. Manager, Analytical Development in San Francisco for a hybrid role leading analytical development, QC, and stability activities at contract manufacturing sites and contributing to clinical asset development and regulatory submissions.

The position requires 10+ years in Analytical Development/Quality Control in pharma, knowledge of cGMP, USP and ICH guidelines, and experience with regulatory filings. Expect travel up to 15%.