Vor Bio
Associate Director, Combination Product Development Lead
Boston, MA · Director
Sponsorship not specifiedDetected 51 days ago
Supply ChainMedical DevicesLeadershipCommunicationCollaborationProblem Solving
About the role
- When you join Vor, you're not just working on a medicine.
- Impact: Contribute directly to a medicine with best-in-disease Phase 3 results in myasthenia gravis and expansion into multiple autoimmune diseases.
- Anticipate and resolve device-drug product interaction challenges to ensure consistent and reliable delivery.
Responsibilities
- Lead development of combination product systems from late-stage development through commercialization.
- Drive design verification and validation activities, including test strategy, execution, and documentation.
- Ensure alignment between device design, container closure systems, and fill-finish processes.
- Own and maintain the end-to-end Design History File / Design Development File (DHF/DDF) across device platforms, ensuring compliance and quality.
- Partner with Quality to support reviews, audits, and inspection readiness.
- Lead risk management activities, including hazard analysis and FMEA, and ensure risks are proactively identified and mitigated.
- Support human factors and usability efforts to ensure alignment with patient needs and intended use.
- Manage and coordinate development activities across external vendors and partners.
- Support governance meetings and drive resolution of risks and dependencies.
- Partner across Supply Chain, Quality, Clinical, Commercial, Regulatory, and Manufacturing teams to align on priorities, timelines, and deliverables.
Requirements
- Proven ability to work across functions and align stakeholders in a fast-paced, matrixed environment.
- Strong understanding of combination product development, design controls, risk management, and verification and validation.
- Bachelor's degree in engineering or life sciences; advanced degree preferred
- Hands-on experience with parenteral injectors.
Nice to have
- Boston, MA preferred
- Roles and Responsibilities
Skills
- Ensure documentation is controlled, accurate, and inspection-ready.
- Skills and Competencies
Compensation
- The salary range for the Associate Director, Combination Product Development Lead is expected to be between $170,000 and $195,000 per year.
Benefits
- Education, Experience and Qualifications
- 8-12+ years of experience in combination product, drug-device, or medical device development
- 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.
- All applicants will be considered for employment agnostic to race, age, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.
- 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.
Company info
- Be part of a rapidly scaling company with opportunities to grow your career in science, clinical development, commercial strategy, and beyond.
- At Vor, we believe science can do more than manage symptoms.
- 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.
- You're part of a mission to redefine the future of autoimmune care.
Equal opportunity
- As an equal opportunity employer, we at Vor Bio know that diversity inspires innovation, inclusiveness, and creativity.
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This listing is sourced directly from Vor Bio's careers page and normalized into a canonical job model.