This position will serve the role of Senior Engineer III, device and container closure system for device development of Alexion products including continuous product improvement within the Development function of Alexion. The candidate will serve as the technical lead for device and container closure system for pipeline products as well as lifecycle management. The candidate will evaluate device and container closure system design and development with vendors, and support the technology transfer efforts for fill finish and drug product assembly. This position will interact with multiple functional teams including Clinical, Manufacturing, Marketing, Purchasing, Quality, Regulatory, and Supply Chain, from clinical development through registration and commercial support. This will be a field based position and expected to report to New Haven site every other week minimally and as needed.
- Lead technical assessment and recommendation of device and/or container closure system for drug delivery.
- Oversee and develop internal and external capability of device and container closure characterization for functionality, integrity and regulatory.
- Support fill finish operation and component qualification for parenterals.
- Work and manage key interfaces in global operation, quality assurance, pharmacovigilance, global medical sciences and regulatory to progress device/combination product development deliverables.
- Interface with device and container closure system partner, internal and external manufacturing from development to commercialization.
- Provides strategic input to compliance on the novel container closure for drug delivery and device technologies.
- Communicate effectively, both verbally and in writing, internally across departments and with external suppliers.
- Ensure all designs function as required and comply with the Company’s quality assurance requirements as well as applicable regulatory requirements.
- This will be a field based position, expected to report to New Haven site every other week minimally and as needed.
- Strong leadership for technical and project management for all aspects of device and container closure system development and commercialization.
- Extensive experience in multiple materials characterization, surface analysis, and pharmaceutical analytical techniques in the field of biotechnology/pharmaceuticals, specialty polymers for device and container closure system.
- Proven expertise in primary containers and their interactions with protein; in depth knowledge in drug delivery, parenteral, and protein formulation.
- Demonstrated ability to facilitate the interface between the pharmaceutical company and the container closure and medical device vendor base
- Strong communication, collaboration and team building skills; ability to connect with all levels of the organization. Proficient in writing internal reports, project summaries, and internal/external presentations
- Deep knowledge of the regulatory and compliance requirements of container closure, device design controls and combination products.
- Bachelor, Master’s or PhD Degree in Engineering (Biomedical, Chemical or Materials Science and Engineering) plus 10-15 year experience (5-10 year for PhD) in medical device/ container closure development with 5+ years in combination product commercialization.
Field, United States
Some opportunities happen only once in a lifetime - like a job where you have the extraordinary opportunity to change lives. At Alexion, such opportunities arise through our unwavering mission to serve patients and families affected by rare diseases. These patients are our guiding star, and we act with integrity, urgency, and discipline because we know their lives are at stake.