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Director, Device Development

Company: Otsuka
Location: Philadelphia
Posted on: November 22, 2021

Job Description:

Position Summary
Reporting to the Senior Director of Technical Services and Device Development & Technology, the Director - Device Development & Technology is a technical expert in the field of combination products & drug delivery devices who can successfully serve in a variety of manufacturing, strategy and engineering/technically focused roles to execute management of combination product /device development from conception to Phase 1 to post-approval and through commercialization. Leverages technical proficiency, creativity and cross functional collaboration to empower decision making. Committed to serving as a partner to all relevant internal and external functional representatives (Manufacturing, Supply Chain, Quality, Regulatory, etc.) to deliver products that are commercially viable and that meet the highest standards of quality and safety for patients.

The Director will lead the organization in defining, coordinating and executing device strategy to support pipeline. Accountable for generating all required documents to support design control requirements (21 CFR 820, ISO 13485 ISO 14971) and regulatory requirements for combination products (21 CFR Part 4). Serves as primary point of contact and escalation point for interactions with vendors, suppliers, testing laboratories, and contract manufacturing organizations (CMOs) to develop and deliver drug/device combination products.

Key Competencies in Team leadership/Regulatory filing processes of combination product device/Risk assessments and FMEA techniques/Combination product device design/Biocompatibility testing/Combination product device manufacturing

The position may involve frequent domestic and international travel up to 20 - 25% as projects require.

Key Job Responsibilities

  • Establish the vision for the Device Development & Technology group
    • Establishes, develops and executes vision and strategy for device design from development through commercialization.
    • Work with the Senior Director, TS & DD Technology, and other functions including Supply Chain, Global Clinical Development, Clinical Supplies Operations, Quality Control, Commercial, Global Regulatory and Global Quality Management to support strategies for department improvements and aligns with the business and OPCJ/OPDC/MDD development programs
    • Leads the device development team by providing technical guidance and mentorship with oversight of all departmental and functional deliverables.
      • Develop and support the strategic and tactical activities of the department:
      • Responsible for drug/device combination products development and validation through the product lifecycle including human factor studies and regulatory filings from product launch to BLA approval and post launch support activities.
      • Directly accountable for CMC support of regulatory filings (IND, NDA, BLA) for combination products in US and ROW (EU, Japan) while working with OPCJ, OPDC, MDD and OAPI departments.
      • Responsible for life-cycle management of combination product related device by evaluating and recommending strategic directions.
      • Responsible for identifying and managing the development and implementation of policies, procedures, and standards for the Device Development & Technology department.
      • Responsible for authoring and/or contributing to product requirements, specifications, verification and validation plans and reports and other design history file (DHF) documentation as required.
      • Responsible for designing and developing robust test protocols to challenge product performance while ensuring adherence to regulatory requirements and applicable standards.
      • Accountable for leading safety risk management assessment activities and defining the critical components of the design, device risk management activities and execute Human Factors Engineering & Usability activities.
      • Responsible for ensuring efficient transfer of products and on-going product support all products to CMO's from device perspective and working with suppliers to ensure the robustness of their designs and processes.
        • Third Party Vendor Selection and Due Diligence - working with key stakeholders (e.g. QM, Sourcing, Finance) to support a program for Vendor Management of all activities to balance internal versus external resources and supply chain due-diligence has been completed for potential product acquisitions thus enabling optimal integration of all newly acquired device products
        • Support strategic sourcing evaluations with key suppliers and partners to leverage optimal supply base costs for all products.
        • Due diligence Ensure rigorous supply chain due-diligence has been completed for potential device acquisitions
          • Staff Development Provide direction and career development opportunities for subordinates. Coach staff in evaluating device development, trouble-shooting and general
            • Department Budget Develop and control department budget appropriately.
              Work with peers within Technical Operations to pro-actively drive COGS lower through the Strategic Plan period.
              • Knowledge, Skills, Competencies, Education, and Experience
                • Bachelor's degree in Engineering or similar related field. Masters or advanced degree preferred.
                • Minimum 15 years of experience in Pharmaceutical Device related departments in the Pharmaceutical/Device industry with 10+ years managing technical resources.
                • Ability to work/lead in a dynamic group that takes a multi-disciplined team approach to executing and achieving departmental and corporate goals
                • Must have managed a significant project budget, > $ 5 Million
                • Demonstrated effective leadership skills especially the management of high-visibility project teams
                • Working knowledge of pharmaceutical products including tablets, capsules, and parenterals as well as devices.
                • In-depth understanding of validation, stability testing, process validation/verification, quality assurance, and regulatory requirements as they pertain to packaging and devices.
                • Ability to work strategically and independently with internal and external groups on multiple projects.
                • Excellent written and verbal communication skills with demonstrated ability to establish and maintain effective communications internally and with external manufacturing partners.
                • Competency in use of business and project management computer software (such as MSProject and MSOffice).
                • Demonstrated effective leadership skills in building high performance teams.
                • In-depth understanding of method validation, stability testing, process validation, quality assurance, and regulatory requirements for devices and drug/device combination products.
                • In-depth understanding of US FDA CMC Regulatory device approval requirements and processes. Familiarity with other health authority (EMA, PMDA) requirements a plus.
                • Ability to work strategically and independently with internal and external groups on multiple projects.
                • Excellent written and verbal communication skills with demonstrated ability to establish and maintain effective communications internally and with external manufacturing partners.
                • Proficient in the use of computers and computer software, including Microsoft Word, Excel, PowerPoint and Project
                • Excellent interpersonal and communication skills
                • Ability to operate in a multi-cultural, multifaceted corporate environment
                • Be task & detail orientedPhysical Demands and Work Environment
                  Travel (approximately 20 - 25%)

                  Come discover more about Otsuka and our benefit offerings; .

                  Disclaimer: This job description is intended to describe the general nature and level of the work being performed by the people assigned to this position. It is not intended to include every job duty and responsibility specific to the position. Otsuka reserves the right to amend and change responsibilities to meet business and organizational needs as necessary. Otsuka is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to their protected veteran or disabled status, or any protected status.

                  Statement Regarding Job Recruiting Fraud Scams

                  Job postings, job offers, or introductions to enter into a business relationship with Otsuka through a third-party vendor may be unauthorized. Avoid being the subject of a scam by dealing only directly with Otsuka through its official Otsuka Career website . Any authorized third-party vendor job boards should redirect any inquiry to this Otsuka Career website.

Keywords: Otsuka, Philadelphia , Director, Device Development, Executive , Philadelphia, Pennsylvania

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