Manager, Pharmaceutical Packaging

About Eidos Therapeutics & BridgeBio Pharma

Eidos Therapeutics, an affiliate of BridgeBio Pharma, is a Phase 3 developmental-stage biopharmaceutical company focused on addressing the large and growing unmet need in diseases caused by transthyretin, or TTR, amyloidosis, or ATTR. We seek to treat this well-defined family of diseases at their collective source by stabilizing TTR. Our investigational product, acoramidis (AG10), is an orally administered small molecule designed to potently stabilize TTR, a potentially best-in-class treatment aiming to halt the progression of ATTR diseases.

BridgeBio is a biopharmaceutical company founded to discover, create, test, and deliver transformative medicines to treat patients who suffer from genetic diseases and cancers with clear genetic drivers. We bridge the gap between remarkable advancements in genetic science in academic institutions and the delivery of meaningful medicines to patients. Founded in 2015, the company has built a portfolio of 30+ drug development programs ranging from preclinical to late-stage development in multiple therapeutic areas including genetic dermatology, precision oncology, cardiology, endocrinology, neurology, pulmonology, and renal disease, with two approved drugs. 

Our focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have U.S. offices in San Francisco, Palo Alto, and Raleigh, with small satellites in other parts of the country. We also have international offices in Montreal, Canada, and Zurich, Switzerland, and are expanding across Europe. 

To learn more about our story and company culture, visit us at eidostx.com/ | https://bridgebio.com

Who You Are

The Manager, Pharmaceutical Packaging, reports directly to the Director of Packaging. This position will have an emphasis on commercial pharmaceutical labeling process, infrastructure, and cross-functional task management with a global perspective. This position may also provide technical and process support for commercial and clinical drug product packaging and labeling operations at BridgeBio both internally and its CPOs. This position may aid in the coordination of aspects of commercial primary/secondary packaging, labeling and serialization, including oversee day-to-day operations, ensure timely completion of associated operations/documentation and assist in the monitoring of cGMP compliance at drug product packaging contract manufacturers.  

Responsibilities

• Function as key labeling process subject matter expert and liaise between Bridgebio Affiliate Drug Product, Analytical Chemistry, Quality Assurance, Regulatory Assurance, Supply Chain Management Departments and contract manufacturers related to packaging operations
• Provide regulatory filing support (IND, IMPD, NDA, MAA, etc.)
• Provide leadership in the assessment and establishment of commercial pharmaceutical labeling process and system
• Serve as the primary BridgeBio technical contact for Drug Product Packaging, to lead efforts to implement the package / labeling design, serialization and perform shipping validation, working with CMOs, component suppliers and related design service providers
• Ensure the timely routing and review of all master batch records (MBRs), standard operations procedures (SOPs), Change Controls, tech transfer reports, validation master plans, commercial labeling (primary/secondary) and other documentation related to commercial and/or clinical drug product packaging and shipping at contractors and/or business partners
• Travel to contract manufacturers or business partners, as required. Travel estimate: 10% (domestic and international)
• Maintain required training status on Bridgebio and/or Affiliate specific work instructions and SOP's
• Support all investigations which concern DP Packaging Manufacturing/Labeling or associated shipping operations, when required
• Ensure product integrity and company reputation by assisting in the monitoring of cGMP compliance at drug product contract manufacturers

No matter your role at BridgeBio, successful team members are:

• Patient Champions, who put patients first and uphold strict ethical standards
• Entrepreneurial Operators, who drive toward practical solutions and have an ownership mindset
• Truth Seekers, who are detailed, rational, and humble problem solvers
• Individuals Who Inspire Excellence in themselves and those around them
• High-quality executors, who execute against goals and milestones with quality, precision, and speed

Education, Experience & Skills Requirements

• Minimum of 7 years of relevant pharmaceutical industry experience is required. B.S. degree in package engineering or a related scientific field is desirable
• Prior experience in pharmaceutical or biopharmaceutical industry is required 
• Prior experience directly working with FDA and ex-US labeling regulations/process is highly desirable
• Direct experience with software based labeling review and approval process is highly desirable
• Knowledge of pharmaceutical labeling creation process and regulatory requirements with direct experience implementing process steps required 
• Familiarity with Esko, Perigord, Veeva labeling management solutions highly desired 
• Broad knowledge of regulatory compliance inclusive of cGMP, FDA/EMA regulations, able to provide regulatory filing support (IND/IMPD, NDA, MAA, etc.) 
• Knowledge and technical experience with full-scale drug product packaging including primary, secondary, and tertiary, bottling/blistering, etc., through to a Finish Goods status  
• Knowledge of DSCSA, FMD, and HDA guidelines  
• Driven for proactive resolution of technical challenges with tact, diplomacy and composure
• Proficient in Excel, PowerPoint, Visio, Word, etc. in addition to experience working within shared work environments. Experience with documentation, change control and quality systems
• Strong interpersonal, written and oral communication skills. Able to provide clear direction to others in ambiguous situations and environments
• Experience in direct collaboration with CMOs/CPOs/external vendors 

What We Offer

• Patient Days, where we are fortunate to hear directly from individuals living with the conditions we are seeking to impact throughout the year and learn how we can improve our efforts
• A culture inspired by our values: put patients first, think independently, be radically transparent, every minute counts, and let the science speak
• An unyielding commitment to always putting patients first. Learn more about how we do this here
• A de-centralized model that enables our program teams to focus on advancing science and helping patients. Our affiliate structure is designed to eliminate bureaucracy and put decision-making power in the hands of those closest to the science
• A place where you own the vision – both for your program and your own career path
• A collaborative, fast-paced, data-driven environment where we inspire ourselves and each other to always perform at the top of our game
• Access to learning and development resources to help you get in the best professional shape of your life
• Robust and market-competitive compensation & benefits package (Base, Performance Bonus, Equity, health, welfare & retirement programs)
• Flexible PTO
• Rapid career advancement for strong performers
• Potential ability to work on multiple BridgeBio Pharma programs across multiple therapeutic areas over time 
• Partnerships with leading institutions
• Commitment to Diversity, Equity & Inclusion