Job Summary (Primary function)
The Biopharmaceutical Development Device Engineering Director will be responsible for the design, development, and implementation of drug delivery devices and systems that support our biopharmaceutical products. This role requires a strong understanding of engineering principles, materials science, and regulatory requirements specific to medical devices and will be a key contributor within the CMC organization. The successful candidate must be a confident downstream specialist with a proven track record in the design, development, submission, launch and manufacturing of these drug delivery systems, while collaborating effectively with diverse teams.
Essential Functions of the Job (Key responsibilities)
·Lead device development activities with confidence and experience to deliver on commitments, including timeline management, budget management, scope, contracts and other device / molecule and business needs.
·Drive the technical and project management aspects of device development for pipeline products and future lifecycle management activities.
·Oversee and integrate design and development activities of vendors for device and combination products. This includes developing the DHF and all required documents within (i.e. PRD, DIR, V&V matrix, Risk Mgmt, Design Reviews and Design Transfer) and the support of technology transfer efforts for final drug product assembly.
·Evaluate device designs for Functionality, Manufacturability, Assembly and Reliability. This includes, but is not limited to, assessing tolerance analyses, Finite Element Analysis (FEA) modeling, Computational Fluid Dynamics, Mold Flow, and other traditional engineering techniques.
·Drive risk management activities both internally and externally with vendors (dFMEA, uFMEA, pFMEA).
·Interface with device partner and external development/manufacturing on fill-finish, drug delivery device scale-up from development to commercial scale industrialization.
·Evaluate existing and required test methods ensuring they are in-place and qualified in a timely manner to support both clinical and commercial supply.
·Ensure all designs function as required and comply with company quality and applicable healthcare authority regulatory requirements.
·Integrate Human Factors Planning activities and deliverables with overall project timelines and regulatory requirements.
·In collaboration with Quality and Regulatory teams, lead the device submission and response activities to regulatory authorities (such as Investigational New Drug (IND) and Biologics License Application (BLA) applications), including overseeing the preparation of technical reports, data summaries and CMC related documents, quality checks and review for scientific integrity.
·Analyze and interpret results and methods, troubleshoot processes, generate solutions to problems and meet related regulatory requirements.
·Create and review technical documents, reports, and presentations for cross functional teams.
·Manage related SOPs, change controls, deviations and CAPAs.
·Willingness to travel, both domestically and internationally, when required, estimating approximately 10-15% of time, with accommodations available for individuals with disabilities.
Qualifications (Minimal acceptable level of education, work experience, and competency)
·Degree (such as Bachelor’s, Master’s, or Ph.D.) in Mechanical Engineering, Biomedical Engineering, or a related discipline, or equivalent relevant experience.
·Significant relevant biopharmaceutical industry experience working in development of drug/device combination products required, with experience working on large molecule programs (monoclonal antibodies preferred) for subcutaneous administration highly valued.
·Demonstrated experience in phase-based design control activities with integrated risk management deliverables and engineering studies from research through registration and launch.
·Understanding of primary containers and their interactions with protein, in-depth knowledge of drug delivery, parenteral and protein formulation.
·Ability to work/lead in a dynamic group that takes a multi-disciplined team approach to executing and achieving departmental and corporate goals.
·Natural entrepreneurial spirit with a hands-on, roll-up-your-sleeves approach with high sense of urgency and dedication to drive for results.
·Strong communication skills (written, verbal and presentation), problem-solving, leadership, and negotiation and decision-making skills.
·Ability to think outside of the box and challenge the status quo while fostering an inclusive environment with diversity of thought.
·Collaborative, self-motivated team player capable of critical and strategic thinking, and able to manage multiple tasks effectively in a dynamic organization.
·Fluency with industry-related guidance & ISO standards.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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