CMC - Lead to Intervacc

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. Why Work at Vor? Impact: Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple autoimmune diseases. Growth: Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, commercial strategy, and beyond. Innovation: Work on a platform with potential beyond one indication — a therapy that has already shown consistent results across lupus, IgA nephropathy, and Sjögren’s syndrome. Belonging: Join a culture where every voice is heard, and where our shared mission unites us across functions and geographies.   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.   At Vor, we support our team with robust benefits, including comprehensive health coverage, flexible paid time off, generous parental leave, and a competitive 401(k). From education assistance to wellness resources and financial security, we invest in your well-being so you can thrive at work and beyond. As an equal opportunity employer, we at Vor Bio know that diversity inspires innovation, inclusiveness, and creativity. We invite you to come as you are. All applicants will be considered for employment agnostic to race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. Please visit our website at https://www.vorbio.com/ for more information.

Do you want to use your strong analytical, problem-solving skills to help find treatments for rare disease patients? About Healx Healx is an AI-powered tech bio company that is redesigning drug discovery. With 10,000 rare diseases affecting 400 million people globally, 90% of which have no approved treatment, Healx is on a mission to pioneer the next generation of drug discovery to help rare disease patients in need. We combine data, artificial intelligence and deep pharmacology expertise to develop treatments more quickly and cheaply than traditional drug discovery. Diversity and inclusion sits at the heart of our mission to help people with rare diseases, and we believe that attracting and empowering a diverse team is critical to achieving this goal. We welcome applications from people from all backgrounds and walks of life. Below we have included the qualities that we feel are required for you to excel in this role; however we appreciate that people can apply transferable skills from all walks of life and experience. If you think you have what it takes, love our mission and resonate with our values but are worried you don't tick every box – we still want to hear from you and encourage you to apply! Our Values Care for Rare – Rare disease patients are at the heart of what we do  Grow as individuals – We are learners always seeking to enhance our expertise  Win as a team – We strive to remain inclusive and diverse and we celebrate successes and lessons together Innovate and deliver – Our mission requires rapid innovation and calculated risks that won’t compromise our high standards  The role Healx is looking for a part-time (60% - 80%) experienced Senior QA Auditor to join the team to lead strong analytical, problem-solving activities that ensure all clinical research (GCP) and manufacturing (GMP) related activities performed by Healx personnel and vendors are carried out in accordance with industry expectations, SOPs, and international regulations.   Healx’s Senior QA Auditor will be working closely with Healx’s Clinical team, they will ensure Healx is inspection-ready and drives continuous quality improvement across both clinical and manufacturing activities. They will ensure all clinical research activities at Healx complies with GCP standards, SOPs, and international regulations, execute Healx’s annual audit plan, and support the team with risk management planning and training. The GMP aspect of this role involves ensuring Healx’s investigational products meet strict GMP standards through Healx’s QMS management.  Key duties include working with Healx’s CMC Director to manage review batch records, auditing (internal, external, supplier), deviation/CAPA investigation, conducting root cause analysis, documentation and change control, handling out-of-spec results, product release and ensuring adherence to regulations.  You will partner closely and report to the Global Head of Clinical Development to provide the strategic oversight and tactical execution of the Quality Management System (QMS).  You’ll be closely collaborating with CMC, Regulatory Affairs, Pre-Clinical and Clinical Operations personnel to maintain compliance and drive continuous improvement in Healx’s QMS and manufacturing of Healx’s investigational products.