Full-Time

Senior Director

Commercial Manufacturing & CMC Development

Confirmed live in the last 24 hours

BridgeBio

BridgeBio

501-1,000 employees

Develops medicines for genetic diseases

Compensation Overview

$230k - $275kAnnually

+ Performance Bonus + Equity

Senior, Expert

San Francisco, CA, USA

This is a hybrid position, which implies that the candidate will be required to work in-office for part of the week.

Category
Biology Lab & Research
Biology & Biotech
Requirements
  • 15+ years in the pharmaceutical industry, with a focus on small-molecule development, commercial manufacturing, and CMC leadership.
  • Deep understanding of API and DP manufacturing, GMP regulations, quality systems, and global supply chain management.
  • Demonstrated ability to lead multidisciplinary teams, manage complex projects, and influence strategic decision-making in a matrixed environment.
  • Direct experience with global regulatory filings, inspections, and compliance standards, including authoring and reviewing Module 3 documentation.
Responsibilities
  • Oversee end-to-end commercial manufacturing activities, including supplier selection, technology transfer, and ongoing process optimization for both drug substance and drug product.
  • Ensure GMP compliance, robust quality systems, and regulatory readiness to support commercial supply and global product launches.
  • Drive the CMC strategy from late-phase development through commercialization, collaborating with cross-functional teams (R&D, Quality, Regulatory, Supply Chain) to ensure seamless integration of manufacturing processes.
  • Lead and advise on CMC-related sections for regulatory submissions, ensuring alignment with international health authority expectations.
  • Manage relationships with CDMOs and raw material suppliers, negotiating contracts, setting performance standards, and overseeing quality and timelines.
  • Continuously evaluate the external network, identifying new partners and implementing improvements to enhance cost-effectiveness and supply reliability.
  • Build, mentor, and inspire a high-performing team of CMC professionals, fostering a culture of innovation, accountability, and continuous improvement.
  • Provide strategic guidance on talent development and resource planning to support evolving business needs.
  • Apply broad scientific knowledge of chemistry, process R&D, and manufacturing best practices to resolve technical challenges.
  • Guide process scale-up, technology transfers, and troubleshooting activities to ensure product consistency and on-target performance.
Desired Qualifications
  • Advanced degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field preferred.

BridgeBio Pharma develops medicines specifically for genetic diseases, focusing on conditions with well-understood genetic causes. The company uses a decentralized subsidiary model, allowing each subsidiary to concentrate on therapies for specific diseases while sharing central resources. This structure enhances efficiency and enables the advancement of multiple drug programs at once. BridgeBio utilizes advancements in genome sequencing and molecular biology to identify and develop effective treatments. Their goal is to create significant therapeutic improvements by targeting diseases at their genetic source. With over 15 drug programs aimed at 20 different genetic diseases, BridgeBio aims to reduce the time it takes to bring treatments to market through a diversified approach. The company promotes a culture of independent thinking and transparency, which supports quick, data-driven decision-making.

Company Size

501-1,000

Company Stage

IPO

Headquarters

Palo Alto, California

Founded

2014

Simplify Jobs

Simplify's Take

What believers are saying

  • Increased focus on RNA-based therapies aligns with BridgeBio's genetic disease mission.
  • Decentralized clinical trials enhance data collection, benefiting BridgeBio's model.
  • Growing personalized medicine demand supports BridgeBio's targeted genetic therapies.

What critics are saying

  • Alnylam's RNAi therapy Amvuttra poses competition to BridgeBio's ATTR-CM treatment.
  • Strategic shifts from new leadership may impact genetic disease program focus.
  • Norges Bank's investment may pressure BridgeBio for short-term financial performance.

What makes BridgeBio unique

  • BridgeBio employs a decentralized subsidiary model for efficient drug development.
  • Focuses on genetic diseases with well-understood underlying causes for targeted therapies.
  • Leverages genome sequencing and molecular biology for innovative treatment solutions.

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Benefits

Health Insurance

Performance Bonus

Company Equity

Unlimited Paid Time Off

Growth & Insights and Company News

Headcount

6 month growth

5%

1 year growth

3%

2 year growth

2%
GlobeNewswire
Feb 26th, 2025
BridgeBio Prices Offering of $500 Million Convertible Senior Notes due 2031 to Refinance Senior Secured Debt

Refinancing term debt facility lowers interest expense, eliminates near-term amortization payments, and significantly extends debt maturityOffering priced...

The Manila Times
Jan 8th, 2025
BridgeBio Pharma to Participate in the J.P. Morgan Healthcare Conference

PALO ALTO, Calif., Jan. 08, 2025 (GLOBE NEWSWIRE) - BridgeBio Pharma, Inc. (Nasdaq: BBIO) ("BridgeBio" or the "Company"), a new type of biopharmaceutical company focused on genetic diseases, today announced that co-founder and CEO, Neil Kumar, Ph.D., will present at the 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA on Monday, January 13 at 7:30 am PT.

Access Market Intelligence
Dec 6th, 2024
Orsini and PANTHERx Rare Selected by BridgeBio as Pharmacy Partners for ATTRUBY

PANTHERx Rare, a leader in rare disease product patient access and support services in the United States, also announced that it was selected by BridgeBio for the distribution of Attruby (acoramidis).

PR Newswire
Nov 26th, 2024
Bridgebio Selects Pantherx® Rare Specialty Pharmacy For Distribution Of Attruby™ (Acoramidis)

PITTSBURGH, Nov. 26, 2024 /PRNewswire/ -- PANTHERx® Rare, a leader in rare disease product patient access and support services in the United States, is pleased to announce that it was selected by BridgeBio for the distribution of Attruby™ (acoramidis), a high-affinity transthyretin (TTR) stabilizer for twice daily oral administration, approved for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM).2,5. Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR. Attruby was designed to mimic a naturally occurring "rescue mutation" of the TTR gene (T119M) that targets the root cause of ATTR-CM, destabilization of the native TTR tetramer. Through near-complete TTR stabilization, Attruby has been shown to preserve the native function of TTR as a transport protein of thyroxine and vitamin A and to demonstrate benefit on cardiovascular outcomes. "Panther is committed to providing tailored solutions for people living with rare and devastating conditions and we look forward to the partnership with BridgeBio and serving the needs of patients suffering from transthyretin amyloid cardiomyopathy," said Rob Snyder, Executive Chair, PANTHERx® Rare Pharmacy

MarketBeat
Nov 24th, 2024
Jennison Associates LLC Invests $767,000 in BridgeBio Pharma, Inc. (NASDAQ:BBIO)

Jennison Associates LLC invests $767,000 in BridgeBio Pharma, Inc. (NASDAQ:BBIO).