- Location
- Remote - Netherlands; Remote - United States
- Workplace
- Remote
- Department
- Manufacturing
- Seniority
- Director
- Education
- Bachelor
- Source
- Greenhouse
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
You lead commercial manufacturing and packaging for our products, with a particular focus on packaging and ex-US supply. You own the external network that turns bulk drug product into a compliant, serialized, market-ready commercial pack — managing artwork, serialization, packaging validation and the CMO partnerships. This role scales in step with our commercial expansion, you will help stand up the capability, not simply inherit it.
Responsibilities
- Own commercial packaging engineering — primary, secondary and serialized packaging — from design and qualification through steady-state supply, ensuring every configuration is manufacturable, compliant and patient-ready.
- Lead ex-US commercial manufacturing and distribution, managing CMOs with our international affiliates, and packaging partners across international markets to meet demand, quality and regulatory requirements.
- Own end-to-end artwork management.
- Own serialization and track-and-trace compliance (e.g. EU FMD, DSCSA and equivalent ex-US requirements), ensuring systems, master data and partners are aligned market by market.
- Lead packaging and process validation, protocols and change control in partnership with Quality and Regulatory, maintaining a state of inspection readiness.
- Manage the commercial manufacturing budget, capacity commitments and supplier performance, negotiating and governing agreements with external partners.
- Partner cross-functionally with Regulatory, Quality, Commercial and Supply Planning to support launches, market expansions and lifecycle changes on time and in full.
Where You'll Work
This is a U.S.-based remote role that will require quarterly, or as needed visits to our San Francisco Office.
Who You Are
Historically the "Experience, Education, & Skills Requirement" section
(5-7 bullets max)
- Bachelor's degree in packaging engineering, engineering, pharmaceutical sciences or a related field; 10+ years in commercial pharmaceutical manufacturing and supply.
- Demonstrated packaging engineering background across primary and secondary drug-product packaging.
- Hands-on ex-US commercial manufacturing and distribution experience, managing CMOs and partners across international markets.
- Deep, practical expertise in artwork management, serialization / track-and-trace, and packaging & process validation.
- Strong command of GMP, change control and regulatory expectations for commercial packaging across multiple geographies.
- Experience launching a commercial product in the US and ex-US markets (EU, LATAM, Japan and others).
- Familiarity with EU FMD, US DSCSA and comparable global serialization regulations.
- Travel – 20%-25% total time will be used for travel
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
