Associate Director Drug Product Technical Operations

Location: Boston, MA preferred

Associate Director, Drug Product Technical Operations 

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 data-driven and risk-based approaches. 

Drug Product and Combination Product Integration: Partner closely with the Combination Product Development Lead to ensure alignment between drug product characteristics, primary container systems, prefilled syringes, needle safety devices, autoinjectors, fill-finish processes, device performance, and product presentation requirements. 

Cross-functional Collaboration: Partner across Supply Chain, Quality, Regulatory, Clinical, Commercial, Combination Product, Alliance Management, and Program Management to align technical strategy, manufacturing execution, regulatory deliverables, and program milestones. 

Program Management: Own Drug Product timelines, technical risks, decisions, dependencies, and deliverables. Maintain integrated plans and trackers in Smartsheet and communicate progress through clear timeline views using Office Timeline. Ensure actions, decisions, and documentation are accurate, traceable, and inspection-ready. 

Skills and Competencies 

Drug Product Expertise: Strong technical understanding of biologic drug product development and manufacturing, including formulation, aseptic processing, fill-finish, container closure systems, visual inspection, process validation, and commercial manufacturing. 

Technical and Operational Ownership: Ability to combine technical depth with strong operational execution. Demonstrated ability to independently lead complex activities, manage multiple priorities, and drive programs from strategy through execution. 

CMC and Regulatory Knowledge: Strong working knowledge of global CMC requirements, Module 3 authoring, process validation, comparability, lifecycle management, and inspection readiness. 

External Manufacturing Leadership: Proven ability to manage CDMOs and external laboratories, establish accountability, influence partner performance, and resolve technical and operational issues in an outsourced manufacturing model. 

Education, Experience and Qualifications 

• Bachelor's degree in engineering, pharmaceutical sciences, chemistry, biotechnology, life sciences, or a related discipline; advanced degree preferred. 

• 8-12+ years of experience in biologics drug product development, manufacturing, technical operations, process engineering, or CMC. 

• Demonstrated experience leading aseptic fill-finish activities from development and engineering through process validation and commercial readiness. 

• Experience leading drug product technology transfers, process scale-up, process validation, manufacturing investigations, change controls, and lifecycle management activities. 

• Demonstrated experience authoring and reviewing Drug Product Module 3 sections and supporting regulatory submissions, health authority responses, or inspections. 

• Experience managing CDMOs and external technical partners in a GMP-regulated and highly outsourced manufacturing environment. 

• Strong understanding of GMP requirements, aseptic processing, validation principles, deviation management, root cause analysis, CAPA, and risk management. 

• Experience with injectable biologics, prefilled syringes, container closure systems, visual inspection, and combination products is strongly preferred. 

• Experience supporting BLA readiness, process performance qualification, commercial launch, and post-approval manufacturing changes is preferred. 
• Strong organizational, program execution, and documentation management skills. 

 

The salary range for the Associate Director, Drug Product Technical Operations is expected to be between $170,000 and $195,000 per year.  Individual pay may vary based on multiple factors including but not limited to relevant job-related skills, experience, education or training, market factors, and work location.