Bicara Therapeutics

Bicara Therapeutics

Senior Director, Commercial Packaging, Serialization and Global Logistics

Boston · Director

Sponsorship not specifiedDetected 82 days ago
GCPBudgetingValuationSupply ChainLogisticsPerformance ManagementGMPFDA RegulatoryLeadershipCollaborationAdaptabilityRegulatory Affairs

About the role

  • Bicara Therapeutics is seeking a Senior Director of Global Logistics, Commercial Packaging and Serialization that will play a pivotal role in shaping and executing Bicara's global Supply Chain strategy.
  • This role will have immediate impact on establishment and oversight of our commercial packaging and distribution along with strategy and operational oversight of the end-to-end global logistics across both clinical and commercial supply chain.
  • This role is based in our Boston office and follows a hybrid schedule, with three in-office days each week.

Responsibilities

  • Provides strategic leadership, functional oversight and operational oversight during the commercial packager selection process. Oversees the RFP process and packaging partner selection, contracting, qualification and ongoing performance management.
  • Ensures that packaging design, artwork implementation, and labeling strategies support regulatory & global compliance requirements while meeting Bicara's commercial objectives.
  • Drives all commercial packaging aspects of the future BLA submission and commercial market launches.
  • Establishes and maintains robust artwork governance, label control process and change management in collaboration with Regulatory Affairs and Quality to ensure continued alignment with approved filings for BLA and ex-US dossiers.
  • Drives the design and implementation of tamper-evident, anti-counterfeiting, and patient safety features across all commercial products.
  • Manages the CMO relationship - meets regularly to monitor performance, manage materials, and ensure adherence to packaging schedule. Manages commercial packaging budget and invoicing.
  • Owns the global serialization strategy including system architecture with internal IT and external partners, drives partner integration and governance across a fully outsourced network.
  • Establish and maintain serialization SOPs and partner with relevant groups to ensure audit readiness for any regulatory inspections related to traceability, data integrity and supply chain security.
  • Collaborate cross-functionally with IT, Quality, Regulatory and other stakeholders to ensure that Bicara's serialization strategy supports patient safety, anti-counterfeiting measures, returns management, and uninterrupted commercial supply.
  • Own Bicara's cold chain strategy and execution, including qualification, validation, monitoring, and operational optimization of shipping lane and systems.

Requirements

  • Bachelor's degree in Business, Supply Chain, Engineering, or a closely related field is required.
  • 12+ years of progressive experience in Supply Chain with strong focus on global logistics, trade compliance, commercial packaging, serialization, and 3PL implementation and oversight within the Life Sciences industry.
  • Functional knowledge of global trade compliance regulations.
  • Experience with cold-chain logistics (2-8°C and frozen) for biologics or other temperature-sensitive products.
  • Balance strategic design with hands-on operational oversight, stepping into tactical issues when required to protect supply continuity.
  • Bachelor's degree in Business, Supply Chain, Engineering, or a closely related field is required. An advanced degree (e.g., MS, PharmD, MBA) is preferred.
  • Deep understanding of GMP, GCP, GDP, and global regulations as applicable to the role. Functional knowledge of global trade compliance regulations.
  • Demonstrated senior leadership experience working within a fully virtual biotech establishment with complex global network of external partners.
  • Highly adaptable and comfortable working in a fast-paced, cross-functional environment with evolving priorities.
  • Strong financial acumen across financial planning, budgeting, and financial KPIs.
  • Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation. Founded in 2020, we've built a global team of over 100 employees headquartered in Boston, with a clear focus on advancing our lead asset, ficerafusp alfa, or FICERA - a potentially first-in-class bifunctional EGFR-directed antibody combined with a TGF-β ligand trap. Our innovative approach combines tumor-targeting with tumor modulation, where one arm localizes to the tumor while the other serves as a modulator, designed to deliver superior efficacy, improved safety, and enhanced durability directly at the tumor site. FICERA specifically addresses a key challenge in solid tumor treatment by enabling immune cell penetration into tumors, reducing fibrosis and immunosuppression while reversing TGF-β-driven resistance mechanisms - ultimately designed to drive the deep, durable responses that may translate into better outcomes and survival for patients. For more information, please visit www.bicara.com http://www.bicara.com.
  • Here at Bicara, we believe in building diverse teams and cultivating a culture where all voices are included. We encourage people from all backgrounds to apply.
  • Bicara Therapeutics is an equal opportunity employer and will not discriminate against any employee or applicant on the basis of age, color, disability, gender, national origin, race, religion, sexual orientation, veteran status, or any classification protected by federal, state, or local law.

Nice to have

  • An advanced degree (e.g., MS, PharmD, MBA) is preferred.

Company info

  • Bicara Therapeutics is a clinical-stage biotech company pioneering bifunctional antibodies for targeted tumor modulation.
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