BridgeBio

1 month ago

Analytical Development - Manager / Sr. Manager

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 4 hours agoStatus: Live

Job Summary

Senior-level analytical development leader within CMC, overseeing CDMOs for drug substance and product, managing QC activities, and driving regulatory analytics for US and RO-WORLD dossiers. Leads method development/validation, stability studies, and reference standards while coordinating with internal teams and external labs to support late-stage development and commercial readiness.

Location: United States

Workplace: Remote

Employment Type: Full time

Job Function: Product Management

Seniority: Sr. Manager level

Key Responsibilities

•Oversee contract development and manufacturing organizations (CDMOs) to manage analytical development and quality control (QC) activities for drug substance (DS) and product (DP).
•Manage analytical documentation (CofAs, test methods, protocols, reports, specifications, stability, and raw data) within Quality Management System (QMS).
•Support and author analytical content for CMC Regulatory content for U.S. and Rest of World dossiers.
•Manage GMP stability studies and provide trend analysis in support of retest and shelf-life extension.
•Development and approval of specifications for raw materials, intermediates, and finished product; knowledge of regulatory requirements in setting specifications.

Pay and Benefits

Salary: USD 163,800 - 177,400 annually

Equity and Bonus:Equity

Perks:401kHealth InsuranceDentalVisionEspp

Key Requirements

•At least 7 years of experience in analytical development in a pharmaceutical setting.
•Proven leadership experience in managing analytical chemists at various levels externally (CMO mgmt.).
•Proficient in analytical techniques (HPLC, LC/MS, GC, GC/MS, USP dissolution, pH meters, UV/Vis spectroscopy, KF) and analytical method validation.
•Knowledge of CMC analytical regulatory requirements and authoring IND/IMPD filings, with experience applying ICH/FDA/EMA guidelines to pharmaceutical development and CMC strategy.
•Travel up to 20% and ability to adapt to changing priorities, with strong vendor communication and project prioritization.

Experience:7+ yearsPharmaceuticalBiopharmaCMCRegulatory

Skills:CommunicationLeadershipVendor managementProject managementPrioritization

Languages:English

Tech Stack:HPLCLC/MSGCGC/MSUSP dissolution testingPH metersUV/Vis spectroscopyKFRegulatory submissionsIND/IMPD

Company Brief

BridgeBio

Develops medicines for patients with genetic diseases by advancing targeted therapeutics from discovery through clinical development and commercialization, focusing on genetically defined diseases with high unmet medical need.

Industry: Biotech

Company Size: Large (251 to 1,000 employees)

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Palo Alto, United States

Founded: 2015

Website LinkedIn

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BridgeBio

1 month ago

Analytical Development - Manager / Sr. Manager

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI

Last checked: 4 hours agoStatus: Live

Job Summary

Location: United States

Workplace: Remote

Employment Type: Full time

Job Function: Product Management

Seniority: Sr. Manager level

Key Responsibilities

•Oversee contract development and manufacturing organizations (CDMOs) to manage analytical development and quality control (QC) activities for drug substance (DS) and product (DP).
•Manage analytical documentation (CofAs, test methods, protocols, reports, specifications, stability, and raw data) within Quality Management System (QMS).
•Support and author analytical content for CMC Regulatory content for U.S. and Rest of World dossiers.
•Manage GMP stability studies and provide trend analysis in support of retest and shelf-life extension.
•Development and approval of specifications for raw materials, intermediates, and finished product; knowledge of regulatory requirements in setting specifications.

Pay and Benefits

Salary: USD 163,800 - 177,400 annually

Equity and Bonus:Equity

Perks:401kHealth InsuranceDentalVisionEspp

Key Requirements

•At least 7 years of experience in analytical development in a pharmaceutical setting.
•Proven leadership experience in managing analytical chemists at various levels externally (CMO mgmt.).
•Proficient in analytical techniques (HPLC, LC/MS, GC, GC/MS, USP dissolution, pH meters, UV/Vis spectroscopy, KF) and analytical method validation.
•Knowledge of CMC analytical regulatory requirements and authoring IND/IMPD filings, with experience applying ICH/FDA/EMA guidelines to pharmaceutical development and CMC strategy.
•Travel up to 20% and ability to adapt to changing priorities, with strong vendor communication and project prioritization.

Experience:7+ yearsPharmaceuticalBiopharmaCMCRegulatory

Skills:CommunicationLeadershipVendor managementProject managementPrioritization

Languages:English

Tech Stack:HPLCLC/MSGCGC/MSUSP dissolution testingPH metersUV/Vis spectroscopyKFRegulatory submissionsIND/IMPD

Company Brief

BridgeBio

Industry: Biotech

Company Size: Large (251 to 1,000 employees)

Growth: Public Company

Valuation: Public Company (Market Cap in USD)

Funding: IPO / Publicly Listed

Headquarters: Palo Alto, United States

Founded: 2015

Website LinkedIn