Packaging Engineer 3

Summary

Join Eidos Therapeutics, a BridgeBio Pharma affiliate, as a Packaging Engineer 3 and contribute to the development of life-changing medicines for patients with unmet needs. You will provide technical and process support for commercial and clinical drug product packaging operations, coordinating commercial primary/secondary packaging engineering operations and serialization. Responsibilities include serving as the BridgeBio technical contact for drug product packaging, liaising between departments and contract manufacturers, ensuring timely review of documentation, supporting packaging activities at contract sites, managing serialization, and providing regulatory filing support. The role requires a minimum of 5 years of relevant pharmaceutical industry experience and a B.S. degree in a related scientific field is desirable. A hybrid role is preferred, with 2-3 days per week in the San Francisco office, but a remote role may be considered. Eidos offers a competitive compensation and benefits package, including comprehensive healthcare, paid parental leave, and opportunities for professional development.

Requirements

• Technical knowledge of commercial-scale OSD pharmaceutical product packaging and labeling, including primary, secondary, and tertiary packaging, is required
• Knowledge of simulated distribution testing standards (ISTA and/or ASTM) required
• 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
• Experience with cGDP documentation, change control, and quality systems (e.g., Veeva, MasterControl, eQMS) required
• A minimum of 5 years of relevant pharmaceutical industry experience is required
• Prior experience in a pharmaceutical company in a packaging engineering-centric role is required

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

Preferred Qualifications

• Serialization experience including direct use of solution provider (such as Tracelink) interface and knowledge of DSCSA and FMD highly desirable
• Knowledge operating with TOPS and/or CAPE palletizing software is desired
• 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
• A B.S. degree in package engineering or a related scientific field is desirable
• 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

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
• 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
• 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
• $110,000 — $135,000 USD