Associate Director, Combination Product Development Lead
Vor Bio
2 days ago
Remote friendly (Boston, MA)
United States
Operations
Associate Director, Combination Product Development Lead
Location: Boston, MA preferred
Roles And Responsibilities
- Combination Product Development: Lead development of combination product systems from late-stage development through commercialization. Translate user needs into product requirements and executable development plans with defined milestones, risks, and timelines. Drive design verification and validation (test strategy, execution, documentation). Ensure alignment between device design, container closure systems, and fill–finish processes.
- DHF Ownership & Compliance: Own and maintain the end-to-end Design History File / Design Development File (DHF/DDF) across device platforms to ensure compliance and quality. Partner with Quality for reviews, audits, and inspection readiness.
- Drug Product Considerations: Apply working knowledge of injectable drug product characteristics (e.g., viscosity, injection forces, dose delivery) to inform device design and performance. Anticipate and resolve device–drug product interaction challenges.
- Risk Management & Usability: Lead risk management (hazard analysis, FMEA) and ensure proactive risk identification and mitigation. Support human factors and usability efforts.
- External Partner Management: Coordinate development activities across external vendors/partners; ensure technical/quality/timeline deliverables are integrated into the DHF and overall program. Support governance meetings and resolve risks/dependencies.
- Cross-functional Collaboration: Partner with Supply Chain, Quality, Clinical, Commercial, Regulatory, and Manufacturing to align priorities, timelines, and deliverables. Support regulatory submissions with complete and consistent device/combination product documentation.
- Program Management: Track timelines, risks, decisions, and deliverables. Maintain plans/trackers in Smartsheet and communicate progress (Office Timeline). Ensure controlled, accurate, inspection-ready documentation.
Skills And Competencies
- Combination Product Expertise: Combination product development, design controls, risk management, verification and validation.
- Execution & Ownership: Operate independently; manage complexity; drive programs with clarity/accountability.
- Cross-functional Leadership: Align stakeholders in a fast-paced, matrixed environment.
- Problem Solving: Analytical/technical problem solving; anticipate risks; drive solutions.
- Communication: Translate complex technical topics into actionable insights.
Education, Experience And Qualifications
- Bachelor’s degree in engineering or life sciences; advanced degree preferred.
- 8–12+ years of experience in combination product, drug–device, or medical device development.
- Demonstrated experience owning a DHF/DDF through development and commercialization.
- Hands-on experience with parenteral injectors.
- Working knowledge of injectable drug product properties and their impact on device performance.
- Experience managing external development and manufacturing partners in a regulated environment.
- Strong organizational, program execution, and documentation management skills.
Compensation And Benefits (as stated)
- Salary range: $170,000–$195,000 per year (individual pay may vary).
- Benefits: comprehensive health coverage, flexible paid time off, generous parental leave, competitive 401(k).
Application Instructions
- Please visit https://www.vorbio.com/ for more information.
Location: Boston, MA preferred
Roles And Responsibilities
- Combination Product Development: Lead development of combination product systems from late-stage development through commercialization. Translate user needs into product requirements and executable development plans with defined milestones, risks, and timelines. Drive design verification and validation (test strategy, execution, documentation). Ensure alignment between device design, container closure systems, and fill–finish processes.
- DHF Ownership & Compliance: Own and maintain the end-to-end Design History File / Design Development File (DHF/DDF) across device platforms to ensure compliance and quality. Partner with Quality for reviews, audits, and inspection readiness.
- Drug Product Considerations: Apply working knowledge of injectable drug product characteristics (e.g., viscosity, injection forces, dose delivery) to inform device design and performance. Anticipate and resolve device–drug product interaction challenges.
- Risk Management & Usability: Lead risk management (hazard analysis, FMEA) and ensure proactive risk identification and mitigation. Support human factors and usability efforts.
- External Partner Management: Coordinate development activities across external vendors/partners; ensure technical/quality/timeline deliverables are integrated into the DHF and overall program. Support governance meetings and resolve risks/dependencies.
- Cross-functional Collaboration: Partner with Supply Chain, Quality, Clinical, Commercial, Regulatory, and Manufacturing to align priorities, timelines, and deliverables. Support regulatory submissions with complete and consistent device/combination product documentation.
- Program Management: Track timelines, risks, decisions, and deliverables. Maintain plans/trackers in Smartsheet and communicate progress (Office Timeline). Ensure controlled, accurate, inspection-ready documentation.
Skills And Competencies
- Combination Product Expertise: Combination product development, design controls, risk management, verification and validation.
- Execution & Ownership: Operate independently; manage complexity; drive programs with clarity/accountability.
- Cross-functional Leadership: Align stakeholders in a fast-paced, matrixed environment.
- Problem Solving: Analytical/technical problem solving; anticipate risks; drive solutions.
- Communication: Translate complex technical topics into actionable insights.
Education, Experience And Qualifications
- Bachelor’s degree in engineering or life sciences; advanced degree preferred.
- 8–12+ years of experience in combination product, drug–device, or medical device development.
- Demonstrated experience owning a DHF/DDF through development and commercialization.
- Hands-on experience with parenteral injectors.
- Working knowledge of injectable drug product properties and their impact on device performance.
- Experience managing external development and manufacturing partners in a regulated environment.
- Strong organizational, program execution, and documentation management skills.
Compensation And Benefits (as stated)
- Salary range: $170,000–$195,000 per year (individual pay may vary).
- Benefits: comprehensive health coverage, flexible paid time off, generous parental leave, competitive 401(k).
Application Instructions
- Please visit https://www.vorbio.com/ for more information.