Sr. Manager, Combination Product Design

The Senior Manager, Device Development is accountable for the technical development of device and combination product programs to ensure commercialization strategy and objectives are met. This role identifies and leads development projects for device and combination product delivery systems, according to established standards for Design Controls and product development processes. This includes providing leadership to a cross-functional team, encompassing all aspects of device development: design input, design output, specification development, test method development, design verification/ validation, process validation, design transfer, and risk management.

The Senior Manager leads the coordination and collaboration with contract development and manufacturing organizations (CDMOs), by serving as the key liaison between internal departments and these key external stakeholders. This role is also responsible for compiling and maintaining the Device History File (DHF) and Device Master Record (DMR) and makes significant contributions to associated regulatory submissions.

Responsibilities:

• Manage Design and Development activities for new and existing drug/device combination products to ensure they meet or exceed requirements and can be manufactured with the highest quality.
• Manage device and combination product development projects effectively using available project management tools.
• Provide subject matter expertise in areas of device development, drug delivery and commercialization.
• Manage the translation of Target Product Profiles (TPPs) into specifications.
• Manage design and development in accordance with regulatory regulations.
• Manage CDMO production for product development, clinical, and commercial launch manufacturing.
• Work in a cross-functional team environment to troubleshoot and resolve technical and manufacturing-related issues.
• Work in compliance with established cGMP quality standards.
• Manage development, manufacturing, and testing operations at contract sites.
• Adhere to departmental and project budgets.
• Contribute to authoring device sections for relevant sections of the eCDT for INDs and NDAs.

Qualifications:

• An M.S. degree in Biomedical or Mechanical Engineering with a minimum of 6 years of relevant pharmaceutical experience is preferred. A Ph.D. with relevant academic research experience may substitute for some industrial experience. Alternatively, a B.S. in Biomedical or Mechanical Engineering with 8 years of industry experience will be considered.
• A minimum of 6 years of experience working with medical devices and pharmaceutical combination products. A minimum of 6 years of experience working in a GMP environment.
• Demonstrated subject matter expertise in medical devices.
• Demonstrated experience in the application of device regulations when drafting FDA and EU submissions.
• Demonstrated experience with engineering documentation and guidelines (i.e. ISO & ASTM).
• Experience in the application of device Quality Management Systems (i.e. 21CFR820 & ISO 13485) and cGMP Part 210 & 211 Requirements for finished pharmaceuticals.
• Demonstrated experience with FDA Design Controls and cGMP principles and related work environments.
• Experience in CAD Software (SOLIDWORKS preferred).
• A minimum of two years of experience with Delivery Device Project Management from Proof-of-Concept stage to Commercialization.
• Proficient with use of Microsoft Word, PowerPoint, Outlook, and Excel and web-based software for various applications.
• Knowledge and understanding of IQ/OQ/PQ process, validation of assembly, processing, and analytical test equipment for device and drug product manufacturing.
• Competencies: Cross functional leadership, Business and strategic alliances and relationships, Results-oriented, Attention to Detail, Interpersonal skills, Verbal and Written Communication skills, Project Management, Analytical skills.
• Working Conditions: Position may require travel and periodic evening and weekend work, as necessary to fulfill obligations and meet corporate goals. This position is based in the Chicago office and requires a minimum of four days per week on-site. On-site requirements may change at management’s discretion.