Job Overview
Employment Type
Full-time
Compensation
Type:
Salary
Rate:
Range $214,400.00 - $242,700.00
Work Schedule
Standard Hours
Flexible
Weekend Shifts
Benefits
Market leading compensation
401k with employer match
Employee Stock Purchase Program
Pre-tax commuter benefits
Referral program
Comprehensive health care with 100 percent premiums covered
mental health support
hybrid work model
unlimited flexible paid time off
Paid parental leave
Flex Spending Accounts
Company-provided group term life and disability
Subsidized lunch
Career pathing and professional development programs
financial rewards
Peer-to-peer recognition
Job Description
BridgeBio Pharma is an innovative biotech company redefining the landscape of medical research and development through collaborative and risk-reducing models. Founded in 2015, BridgeBio pioneered a unique 'moneyball for biotech' approach that consolidates promising early-stage research from academia under a single financial umbrella. This strategy accelerates the development of breakthrough treatments by empowering small teams of experts and scientists to lead projects efficiently, particularly in the rare disease space. The company is deeply committed to unlocking innovation and delivering life-changing medicines to patients with unmet medical needs as rapidly as possible. BridgeBio’s model fosters a culture of boundary-pushing and problem-solving,... Show More
Job Requirements
- At least fifteen (15) years of experience in supply chain management and/or manufacturing functions in the pharmaceutical and/or biotechnology industries
- Bachelor's or Master's degree in a scientific discipline
- Detailed understanding of the pharmaceutical business, including clinical development and commercial manufacturing
- Proven experience with forecasting, demand/supply planning, inventory management, packaging, labeling and distribution
- Proven experience managing and developing a team of professionals
- Experience with SAP or similar ERP platform
- Experience with product serialization and DSCSA standards
- Experience with Veeva or other QMS platform
- Experience with clinical blinding practices
- Experience in assisting set-up of IRT Systems for global clinical studies
- Demonstrated skills in project management and vendor management
- Working knowledge of drug development process (Phase I-IV)
- Working knowledge of current GMP/GCP/GDP guidance and regulations
- Familiar with US and EU import/export regulations
- Excellent attention to detail, strong data analysis, problem solving and decision-making ability
- Proven ability to develop, communicate, and gain support for execution plans with stakeholders
- Ability to handle multiple projects simultaneously
- APICS certification or supply chain education preferred
- Position may require occasional evening and/or weekend commitments
- Position may require occasional travel up to 20 percent domestic and international
- Salary commensurate with experience and qualifications
Job Qualifications
- At least fifteen (15) years of experience in Supply Chain Management and/or Manufacturing functions in the pharmaceutical and/or biotechnology industries
- Bachelor's or Master's Degree in a scientific discipline
- Detailed understanding of the pharmaceutical business, including both clinical development and manufacturing and commercial manufacturing and supply chain
- Proven experience with forecasting, demand/supply planning, inventory management, packaging, labeling and distribution including cold chain, import/export and reverse logistics
- Proven experience managing and developing a team of professionals
- Experience with SAP or similar ERP platform
- Experience with product serialization, TraceLink or other similar platform and DSCSA standards
- Experience with Veeva, or other similar QMS platform
- Experience with clinical blinding practices
- Experience in assisting set-up of IRT Systems for global clinical studies
- Demonstrated skills in project management and vendor management
- Working knowledge of drug development process (Phase I-IV)
- Working knowledge of current GMP/GCP/GDP guidance and regulations
- Familiar with US and EU import/export regulations
- Excellent attention to detail, strong data analysis, problems solving and decision-making ability all while working in a fast-paced and dynamic environment
- Proven ability to effectively develop, communicate, and gain support for execution plans with a wide range of stakeholders
- Ability to handle multiple projects simultaneously
- APICS certification or supply chain education preferred
Job Duties
- Manage a global team of supply chain professionals, responsible for both clinical and commercial end-to-end supply chain
- Manage all aspects of commercial supply chain, including Drug Substance and Drug Product Contract Manufacturing Organizations (CMOs), Packaging and Labeling activities with Contract Packaging organizations (CPOs), Finished Good receiving, put away, storage and distribution activities at Third Part Logistics Providers (3PLs)
- Coordinate logistics of material transfer for clinical and commercial drug substance, drug product and components to/from international CMOs/CPOs, managing exportation, applicable USDA/FDA licenses and permits, VAT recovery and customs brokers
- Own the global Sales & Operations Planning (S&OP) process for all commercial products, coordinating with global market access team for demand planning, finance team for financial planning and driving ownership of final supply plan to be communicated to global partners
- Own and actively manage the commercial supply plan, all commercial inventory, both in process and finished goods
- manage shelf life and expiration
- Own and manage all serialization activities for commercial products globally
- Manage clinical packaging and labeling activities including label design, translation, production, distribution and inventory management
- Provide clinical demand signals, translate the total demand into a demand forecast over time based on a clinical protocol or study overview
- Prepare a clinical supply plan to support the demand, including determination of supply overage amounts, monitor inventory and provide regular inventory update to project teams
- Monitor clinical drug expiry/retest dating
- initiate inventory release and re-supply, serving as the unblinded inventory manager
- Manage domestic and international distribution and logistics for clinical programs, including importing and exporting clinical supplies and developing distribution instructions with clinical supply vendors
- Support budget activities, including managing supplier contracts, PO generation and invoicing approvals for clinical and commercial purchases
- Work collaboratively with QA to manage supply chain activities such as batch release, final release, temperature excursions and to support the investigation of any deviations in a timely manner
- Work with CMC as a liaison to clinical operations and also on the evaluation of new CMOs or CPOs for commercial supply chain
- Work with Global Trade & Distribution and global Finance teams to manage global 3PLs, ensuring quality Finished Good inventory management, distribution and logistics, sales and revenue reporting
- Generate and maintain global SOPs in Veeva QMS and ensure updates and compliance with industry standards
- Develop and maintain strong internal cross-functional collaboration with stakeholders, such as CMC, Clinical Operations, Market Access, Finance, Quality, and Regulatory Affairs
Job Qualifications
Experience
Expert Level (7+ years)
Job Location
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