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Associate Director in R&D Neuroscience at Johnson & Johnson developing precision medicines for complex brain health challenges. Collaborating with cross - functional teams to drive implementation of innovative strategies.
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Hybrid Associate Director – Device Development, Prefilled Syringes & Auto-Injectors
Posted 12 hours ago
About the role
- Leading device development for prefilled syringes and auto-injectors at Oruka Therapeutics. Seeking experienced professionals to drive end-to-end development from clinical stages through commercialization.
Responsibilities
- Lead development of prefilled syringes, auto-injectors, and related delivery systems from late-stage clinical development through commercialization.
- Define and execute device development strategies, including design, verification, validation, and lifecycle management.
- Oversee combination product integration, ensuring alignment with CMC, clinical, and regulatory strategies.
- Drive human-centered product development, incorporating patient, caregiver, and healthcare provider needs.
- Lead human factors engineering (HFE) activities, including use-related risk analysis, formative and summative (validation) studies.
- Ensure compliance with FDA, EMA, and global HFE/usability requirements.
- Provide subject matter expertise in biomedical engineering and device technologies.
- Lead cross-functional teams across development, clinical, regulatory, quality, and manufacturing.
- Independently manage external partners, including device manufacturers, design firms, and testing laboratories.
- Provide MSAT leadership for device and combination product manufacturing across clinical and commercial stages.
- Partner with CMOs and internal teams to ensure robust manufacturing processes, tech transfer, and scale-up.
- Drive investigations, deviations, CAPAs, and continuous process improvements related to device and combination product manufacturing.
- Support regulatory submissions (e.g., IND, BLA) with device-related content.
- Ensure compliance with combination product regulations (21 CFR Part 4, ISO 13485, IEC 62366, ISO 14971).
Requirements
- PhD, or MS in Biomedical Engineering, Mechanical Engineering, or related field.
- Associate Director: 8+ years of relevant experience.
- Director: 12+ years of relevant experience.
- Significant experience in combination products and drug delivery devices, particularly prefilled syringes and/or auto-injectors.
- Proven track record supporting late-stage development and commercialization.
- Strong knowledge of medical device design and development processes.
- Strong knowledge of human factors engineering / usability engineering.
- Strong knowledge of risk management.
- Strong knowledge of design controls and validation requirements.
- Strong knowledge of MSAT and manufacturing support for combination products.
Benefits
- Competitive salary and benefits package.
- Opportunities for professional growth and development.
- A chance to be part of a vibrant startup culture where your work can directly impact bringing new medicines to patients.
- A supportive and inclusive team environment where everyone is encouraged to bring their authentic selves to work.
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