Manager, Pharmaceutical Packaging
BridgeBio - San Francisco, California, United States, 94199
Work at BridgeBio
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Overview
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 under one financial umbrella to reduce risk and unleash innovation. This model allowsscience and small teams of experts to lead the way. We build bridges to groundbreaking advancements in rare diseases 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. Affiliate Overview
Eidos Therapeutics, an affiliate within BridgeBio Pharma,is a commercial-stage biopharmaceutical company focused on Transthyretin Amyloid Cardiomyopathy (ATTR-CM). What You’ll Do
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 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 Who You Are
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 Rewarding Those Who Make the Mission Possible We have high expectations for our team members. We make sure those working hard for patients are rewarded and cared for in return. Market leading compensation 401K with 100% employer match on first 3% & 50% on the next 2% Employee stock purchase program Referral program with $2,500 award for hired referrals Comprehensive health care with 100% premiums covered - no cost to you and dependents Mental health support via Spring Health (6 therapy sessions & 6 coaching sessions) Hybrid work model - employees have the autonomy in where and how they do their work Unlimited flexible paid time off - take the time that you need Paid parental leave - 4 months for birthing parents & 2 months for non-birthing parents Flex spending accounts & company-provided group term life & disability Subsidized lunch via Forkable on days worked from our office 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, Spring Health & BetterUp Coaching We celebrate strong performance with financial rewards, peer-to-peer recognition, and growth opportunities At BridgeBio, we strive to provide a market-competitive total rewards package, including base pay, an annual performance bonus, company equity, and generous health benefits. Below is the anticipated salary range for candidates for this role who will work in California. The final salary offered to a successful candidate will depend on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, educational background, location of residence and performance during the interview process. BridgeBio is a multi-state employer, and this salary range may not reflect positions based in other states. $140,000 - $178,000 USD Apply for this job
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