Associate Director Drug Product Technical Operations

Associate Director Drug Product Technical Operations

Join us in tackling autoimmune disease at its root.

At Vor, we believe science can do more than manage symptoms. It can change the course of disease. By advancing telitacicept, a first- and potentially best-in-class dual BAFF/APRIL inhibitor, we are silencing upstream survival signals and stopping downstream autoimmune cascades. Together, we are addressing disease at its root cause and rewriting what is possible for patients worldwide.

When you join Vor, you're not just working on a medicine. You're part of a mission to redefine the future of autoimmune care.

Location:

Boston, MA preferred

Position Summary

We are seeking an Associate Director, Drug Product Technical Operations to lead the technical and operational execution of drug product activities across Vor's external manufacturing network.

This role will have end-to-end accountability for drug product manufacturing from late-stage development through commercialization, including manufacturing strategy, technology transfer, aseptic fill-finish, process validation, lifecycle management, commercial readiness, and Drug Product Module 3 content.

You will operate at the intersection of technical operations, manufacturing, Quality, Regulatory, Supply Chain, Clinical, and external partner execution. You will serve as the technical owner for Drug Product activities while also driving day-to-day operational execution, with direct impact on product quality, regulatory timelines, supply continuity, and commercial launch readiness.

Roles and Responsibilities

• Drug Product Technical Leadership: Serve as the technical owner for drug product development and manufacturing activities across formulation, compounding, sterile filtration, aseptic fill-finish, visual inspection, container closure systems, and packaging. Apply technical judgment to define manufacturing approaches, evaluate process performance, and resolve complex drug product issues.
• Manufacturing Operations: Lead planning, readiness, and execution of engineering, clinical, validation, and commercial manufacturing campaigns across external manufacturing sites. Ensure materials, documentation, equipment, methods, and cross-functional decisions are in place to support successful and timely campaign execution.
• CMC Strategy: Partner with senior leadership to define and execute the Drug Product CMC strategy across development and commercialization. Support decisions related to manufacturing network design, scale-up, process changes, regulatory strategy, technical risk, supply continuity, and lifecycle management.
• Process Validation and Commercial Readiness: Lead development and execution of drug product validation strategies, including engineering runs, media fills, process performance qualification, hold-time studies, shipping studies, cleaning validation, and continued process verification. Drive readiness for BLA submission, pre-approval inspection, commercial launch, and routine supply.
• Technology Transfer and Lifecycle Management: Lead drug product technology transfers, process scale-up, site transfers, process improvements, and post-approval changes. Ensure technical requirements, knowledge transfer, comparability considerations, validation needs, and regulatory impacts are clearly defined and executed.
• Module 3 and Regulatory CMC Ownership: Lead authoring, technical review, and maintenance of Drug Product Module 3 content for INDs, BLAs, supplements, and global regulatory submissions. Partner with Regulatory Affairs and Quality to ensure manufacturing descriptions, process controls, validation strategies, comparability assessments, container closure information, and supporting technical documentation are complete, consistent, and submission-ready.
• Health Authority and Inspection Support: Support health authority meetings, information requests, regulatory responses, audits, and inspections. Provide clear technical rationale for manufacturing strategies, process changes, validation approaches, deviations, and risk assessments.
• External Partner Management: Serve as Vor's primary technical and operational interface with Drug Product CDMOs, testing laboratories, and other external partners. Lead technical governance meetings, establish clear expectations, track commitments, and drive timely resolution of risks, issues, and dependencies.
• Manufacturing Documentation: Review and approve, as appropriate, master and executed batch records, protocols, reports, specifications, change controls, deviations, investigations, CAPAs, risk assessments, validation documents, and campaign summaries. Ensure documentation is technically sound, controlled, and inspection-ready.
• Deviation and Investigation Leadership: Provide technical leadership for manufacturing deviations, atypical results, batch-impact assessments, root cause investigations, and corrective and preventive actions. Ensure issues are escalated appropriately and resolved using…