Senior Manager Analytical Operations

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

Benefits offered by this job

Market-leading compensation

401(k) with employer match

Employee Stock Purchase Program (ESPP)

Pre-tax commuter benefits

Referral bonus

Subsidized lunch and parking

Comprehensive medical, dental and VISN

Hybrid work model

Job summary

BridgeBio seeks a motivated analytical development scientist and quality control professional to manage analytical development, QC, and stability activities at contract manufacturing sites and to contribute to regulatory submissions. This position requires collaboration with Drug Substance, Drug Product, and Quality Assurance groups.

This role demands 10+ years in Analytical Development/Quality Control, familiarity with cGMPs/ICH, and proficiency with JMP, Veeva Vault, TrackWise, and LIMS; 5-15%

Qualifications

• 10+ years in Analytical Development and/or Quality Control in a pharmaceutical setting.
• Familiarity with CMC analytical regulatory requirements and IND/IMPD/BLA/NDA/MAA filings.
• Proficient in analytical techniques for biologic and small molecule development.
• Strong communication with vendors; manage project timelines and updates.
• Thorough understanding of cGMP, USP, ICH guidelines and industry best practices.
• Stability program management, data trending (JMP) and shelf-life assignment.
• Experience with QA to close investigations and deviations; CAPA leadership.
• Proficient with QA systems such as Veeva Vault, TrackWise, and LIMS.

Responsibilities

• Manage contract drug substance and drug product analytical development and QC activities.
• Review analytical method transfer documentation and validation protocols/reports.
• Review stability protocols and monitor stability program.
• Author, review, and approve analytical technical reports.
• Author, review, and adjudicate CMC sections for US and ex-US filings.
• Collaborate with QA to close investigations and deviations.
• Manage reference standards and critical reagents programs across CDMOs.
• Direct batch release support by reviewing sampling plans and data; generate CoAs/CoTs.
• Partner with QA to manage change controls; lead OOS/OOT investigations and CAPAs.
• Develop, revise, and approve SOPs and QC processes to improve compliance.

Skills

Analytical Development

Quality Control

Stability Program Management

cGMPs

ICH Guidelines

JMP

Veeva Vault

TrackWise

LIMS

Regulatory filings (IND/IMPD/BLA/NDA//

Tools

JMP

Veeva Vault

TrackWise

LIMS

Job description

Mavericks Wanted

When was the last time you achieved the impossible? If that thought feels overwhelming, you might want to pause here, but if it sparks excitement...read on

In 2015, we pioneered a "moneyball for biotech" approach, pooling projects and promising early-stage research from academia together under one financial umbrella to reduce risk and unleash innovation. This model allows science and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare disease, and develop life-changing medicines for patients with unmet needs as fast as humanly possible.

Together we define white space, push boundaries, and empower people to solve problems. If you're someone who defies convention, join us and work alongside some of the most respected minds in the industry. Together, we'll ask "why not?" and help reengineer the future of biopharma. At BridgeBio, we value curiosity and experimentation-including the ethical & thoughtful use of AI to improve clarity, speed, and quality of work.

What You'll Do

BridgeBio seeks a motivated, knowledgeable, and hands-on analytical development scientist and quality control professional to manage analytical development, QC, and stability activities at contract manufacturing sites and to contribute to the development of clinical assets and regulatory submissions. This position requires close collaboration with the Drug Substance, Drug Product, and Quality Assurance groups. This candidate should know the various analytical techniques across modalities. In addition, this individual should be experienced in test method development, analytical method transfer, phase-appropriate method validation, and stability program management (including data trending and analysis) for both drug substances and drug products. A thorough understanding of relevant ICH quality guidelines and excellent communication skills (both verbal and written) is required.

Responsibilities

• Management of contract drug substance and drug product analytical development and quality control activities and timelines


• Review analytical method transfer documentation


• Review analytical method validation protocols/ reports


• Review stability protocols and monitor stability program


• Author, review, and approve analytical technical reports


• Author, review, and adjudicate relevant CMC sections for US and ex-US regulatory filings.


• Collaborate with Quality Assurance to close investigations and deviations


• Manage reference standards and critical reagents programs, including qualification, re-testing strategies, and bridging activities across CDMOs


• Direct batch release support by reviewing and approving sampling plans and analytical data; generate and maintain CoAs, CoTs, and product specifications


• Partner with QA to manage change controls; lead OOS/OOT and deviation investigations to identify root causes and implement CAPAs


• Develop, revise, and approve SOPs and QC processes, enhancing compliance, consistency, and operational efficiency

Where You'll Work

This is a U.S-based remote/hybrid/on-site role that will require as needed visits to our San Francisco Office.

Who You Are

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 of IND/IMPD/BLA/NDA/MAA filings and responses to regulatory inquiries


• Independently proficient in a variety of analytical techniques in support of biologic and small molecule development.


• Ability to communicate effectively with vendors regarding project scope, scientific results and project updates. Ability to understand project timelines and appropriately prioritize activities to achieve project goals.


• Thorough understanding of cGMPs, USP and ICH guidelines, and industry best practices.


• Subject matter expertise in stability program management, including protocol design, data trending and analysis (e.g., using JMP), and shelf-life assignment/extension.


• Proficient with enterprise quality management systems such as Veeva Vault, TrackWise, and LIMS.


• The position will require an ability to adapt to changes in priorities on short notice and will also require an ability to make decisions, independently, under tight timelines.


• Position requires 5-15% travel. Must have the ability to travel internationally.

At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states.

Salary

$130,000-$159,700 USD

As a global company, our comprehensive benefits may vary based on location. We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return.

For BridgeBio Full-Time U.S Based Roles:

Financial & Rewards

• Market-leading compensation

• 401(k) with employer match

• Employee Stock Purchase Program (ESPP)

• Pre-tax commuter benefits (transit and parking)

• Referral bonus for hired candidates

• Subsidized lunch and parking on in-office days

Health & Well-Being

• 100% employer-paid medical, dental, and vision premiums for you and your dependents

• Health Savings Account (HSA) with annual employer contributions, plus Flexible Spending Accounts (FSA)

• Fertility & family-forming benefits

• Expanded mental health support (therapy and coaching resources)

• Hybrid work model with flexibility

• Flexible, "take-what-you-need" paid time off and company-paid holidays

• Comprehensive paid medical and parental leave to care for yourself and your family

Skill Development & Career Paths:

• People are part of our growth and success story - from discovery to active drug trials and FDA pipelines, there are endless opportunities for skill development and internal mobility

• We provide career pathing through regular feedback, continuous education and professional development programs via LinkedIn Learning, LifeLabs, & BetterUp Coaching

• We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities