Senior Manager, Combination Product Development

This is an Individual Contributor position, reporting to the Director of Device Development and Technology. This individual is knowledgeable in the field of combination products &drug delivery devices Primary expertise shouldbe demonstrated in engineering, device quality systems (CFR 820, ISO 13485), human factors engineering principals, risk management for medical devices (ISO 14971), etc. The successful candidate should demonstrate strong technical writing and presentation skills and be able to translate technical information to non-technical audiences.

This position requires 5-8 years of applicable experience in the pharmaceutical, biotechnology or medical device industries.

The candidate will be responsible for the management of design history files and support authoring of technicaldossiers for combination product and device projects for new and existing platforms. Additional responsibilities include facilitation of risk assessments, coordination of human factors usability studies, creation and management of product and component specifications, design control documents, engineering protocols, technical reports, and frequent presentations to project teams and management.

This position will frequentlyrequire management of outside resources as well as assigned and/or unassigned leadership of project teams in a matrix organization. Technical Writing experience required.

The position may involve frequent domestic and international travel up to 15-20% or as required by the project.

• Support the vision for the Device Development function
• Support a vision with appropriate strategies that supports the OPDC objectives and aligns with the business and OPCJ/OPDC/MDD development programs
• Work with members of Device Development and Technology, and other functions including Packaging,Supply Chain, Clinical Supplies Operations, Quality Control, Regulatory and Quality Management tosupport strategies for product and process improvements.
• Develop and support the strategic activities of the department
• Support appropriate filing strategies working with OPCJ, OPDC, MDD and OAPIdepartments to support registration of all new products and life-cycle management products.
• Evaluate new and innovative delivery device technologies to support new and life-cycle management projects.
• Develop and perform the tactical activities
• Ensure efficient transfer of products and on-going product support all products to CMO's from deviceperspective.
• Develop and maintain departmental knowledge, experience, and expertise in state-of-the-art devices for pharmaceutical products.
• Assure adherence to latest worldwide regulatory rules and guidance concerning devices and work todevelop device risk mitigation.
• Create, maintain, and update device related documents required for regulatory filings and compliance
• Facilitate studies as required.
• Write protocols, reports, specifications, procedures, change control requests, technical assessments, etc.
• Program management of Device projects
• Develop project plans and corresponding project managements tools to support the execution of all projects
• Manage cross functional teams (including 3rd party resources)
• Execute Human Factors Engineering & Usability activities

Knowledge/

Experience and Skills:

• 5-8 years' experience in Pharmaceuticals, Medical Devices, Biotechnology, or other related industries
• In-depth understanding of device verification including functional testing, process validation/verification, quality assurance, and regulatory requirements as they pertain to and devices.
• Ability to work strategically and independently with internal and external groups.
• Demonstrated leadership skills especially the management of high-visibility project teams
• Demonstrat…