Manager/Senior Manager, Pharmaceutical Packaging

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Eidos Therapeutics, a subsidiary of BridgeBio Pharma, is a clinical-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 product candidate, 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 finds, develops, and delivers breakthrough medicines for genetic diseases. The company bridges remarkable advancements in genetic science with the entrepreneurial engine required to rapidly create lifesaving medicines for patients with unmet needs. Founded in 2015 by a team of industry veterans, the company has built a portfolio of 20 transformative drugs ranging from pre-clinical to late-stage development in multiple therapeutic areas, including genetic dermatology, oncology, cardiology, neurology, endocrinology, renal disease, and ophthalmology. The company’s focus on scientific excellence and rapid execution aims to translate today’s discoveries into tomorrow’s medicines. We have offices in San Francisco, Palo Alto, Boston, New York, and Raleigh with small satellites in other parts of the country. 

To learn more, visit us at eidostx.com/ www.bridgebio.com

Location

San Francisco, CA

Who You Are

The Manager/Sr. Manager, Pharmaceutical Packaging provides technical and process support for all aspects of clinical and commercial drug product packaging operations at Eidos Therapeutics’ CMOs. Coordinates all aspects of primary/secondary packaging operations, including oversee day-to-day operations, ensure timely completion of associated operations/documentation, and assist in monitoringcGMPcompliance for drug product packaging contract manufacturers.

Responsibilities

  • Serve as the primary Eidos 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
  • Liaison between Eidos Therapeutics’ Formulations Drug Product, Analytical Chemistry, Quality Assurance, Supply Chain Management Departments, and contract manufacturers related to packaging operations
  • Ensure the timely routing and review of all master batch records (MBRs), standard operations procedures (SOPs), Change Controls, tech transfer reports, validation master plans, and other documentation related to the clinical and commercial drug product packaging and shipping at contractors and/or business partners
  • Coordinate all DP Packaging Manufacturing activities at contract manufacturing sites, including but not limited to scheduling of all batches, verifying supply of materials, direct shipment of bulk and finished product at the manufacturing site, track and monitor cycle times, and providing any required associated reports and technical expertise
  • Travel to contract manufacturers or business partners, as required
  • Provide regulatory filing supports (IND, IMPD, NDA, MAA, etc.)
  • Maintain required training status on Eidos specific work instructions and SOP’s
  • Support all investigations which concern DP Packaging Manufacturing 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
  • This role will report to Sr. Director Supply Chain Management

Education, Experience & Skills Requirements

  • Level to be determined based on qualifications relevant to the role
  • B.S. degree in package engineering, mechanical engineering, biomedical engineering, chemical engineering, or a related scientific field and a minimum of 6 years of relevant industry experience is required; Advanced degree(s) with commensurate industry experience is also considered
  • Prior experience in a cGMP-related and regulated industry is highly desirable
  • Knowledge of the FDA regulations, USP, and cGMPs are highly desirable
  • Extensive knowledge and technical experience with full-scale drug product packaging manufacturing, including primary, secondary, and tertiary, bottling/blistering, etc., through to a Finish Goods status, including labeling experience and serialization for clinical and/or commercial
  • Driven for proactive resolution of technical challenges with tact, diplomacy, and composure
  • Broad knowledge of regulatory compliance inclusive of cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations, and able to provide regulatory filing support (IND/IMPD, NDA, MAA, etc.)
  • 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 collaborating with CMOs/CROs
  • Ability to travel up to 25% (domestic and international)

What We Offer

  • Patient Days, where we are fortunate enough to learn more about the lives we are looking to impact and a real exchange of ideas as to 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
  • Learning and development training to help employees be the best version of themselves
  • Collaborative business environment
  • Excellent compensation package (Base, Performance Bonus, Stock, RSU programs)
  • Excellent benefits package
  • Flexible PTO
  • With office locations in San Francisco, Boston, New York, and Raleigh, there are ample cross-collaboration opportunities with other BridgeBio Pharma programs
  • A fast-paced, data-driven, work environment with world-class R&D minds and capabilities
  • Work with the most productive groups of R&D operators in the industry
  • Partnerships with leading institutions
  • A platform for meaningful scientific contributions to shine
  • Commitment to Diversity & Inclusion – with initiatives like Women at Bridge, we are committed to fostering an inclusive environment where every person feels respected for who they are, empowered to contribute, inspired to lead, and supported in their efforts to do so
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Manager/Senior Manager, Pharmaceutical Packaging

Apply Now