Packaging Engineer 3

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.

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 Packaging Engineer 3 reports directly to the Director, Pharmaceutical Packaging. This position provides technical and process support for commercial and clinical drug product packaging operations at BridgeBio CPOs. It coordinates commercial primary/secondary packaging engineering operations and serialization, including overseeing day-to-day operations, ensuring timely completion of associated operations/documentation, and assisting in the monitoring of cGMP compliance at drug product packaging contract manufacturers.

Responsibilities

• Serve as the 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
• Liaison between Bridgebio Affiliate Drug Product, Analytical Chemistry, Quality Assurance, Regulatory 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 operating 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
• Support all DP Packaging activities at contract packaging sites, including—but not limited to—verifying the supply of materials, direct shipment of bulk and finished products at the manufacturing site, and providing any required associated reports and technical expertise
• Aid in the management of BridgeBio commercial serialization and train others as the SME as needed
• Travel to contract manufacturers or business partners, as required. Travel estimate: 15% (domestic and international)
• Provide regulatory filing support (IND, IMPD, NDA, MAA, etc.)
• Maintain required training status on Bridgebio and/or Affiliate-specific work instructions and SOPs
• Support all investigations that concern DP Packaging 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

Knowledge, skills, and abilities:

• Technical knowledge of commercial-scale OSD pharmaceutical product packaging and labeling, including primary, secondary, and tertiary packaging, is required
• Serialization experience including direct use of solution provider (such as Tracelink) interface and knowledge of DSCSA and FMD highly desirable
• Knowledge of simulated distribution testing standards (ISTA and/or ASTM) required
• Knowledge operating with TOPS and/or CAPE palletizing software is desired
• Proven ability to author technical protocols, reports, and assessments
• Experience in direct collaboration with CMOs/CPOs/external vendors
• Driven for proactive resolution of technical challenges with tact, diplomacy, and composure in a highly cross-functional environment
• Broad knowledge of regulatory compliance, including cGMP, FDA regulations, familiarity with ICH guidelines and EU regulations, and able to provide regulatory filing support (IND/IMPD, NDA, MAA, etc.) desired
• Knowledge of primary/secondary packaging materials and ability to provide leadership in material selection and implementation
• Strong interpersonal, written, and oral communication skills. Able to provide clear direction to others in ambiguous situations and environments

Where You'll Work

A hybrid role is preferred, requiring in-office collaboration 2- 3x per week in our San Francisco Office. A remote role can be considered based on the candidate.

Who You Are

A minimum of 5 years of relevant pharmaceutical industry experience is required. A B.S. degree in package engineering or a related scientific field is desirable.

• Prior experience in a pharmaceutical company in a packaging engineering-centric role is required
• Experience with cGDP documentation, change control, and quality systems (e.g., Veeva, MasterControl, eQMS) required
• Direct experience with serialization solution (Tracelink, Systech, etc) desired
• Experience in collaborating with CMOs in a virtual company is desired
• Experience with global product launches and CMC regulatory requirements is desired

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. 

Financial Benefits:

• Market leading compensation 
• 401K with 100% employer match on first 3% & 50% on the next 2%
• Employee stock purchase program
• Pre-tax commuter benefits
• Referral program with $2,500 award for hired referrals

Health & Wellbeing:

• 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