Teva Pharmaceuticals USA, Inc.

Device Team Lead

Location US-PA-West Chester
Requisition #
18-20778
# Positions
1
Experience (Years)
12
Category
Research & Development - Biopharmaceutics

Overview

As a Device Team Lead – R&D Devices in Teva’s West Chester R&D Devices group, you will lead the development of combination products including injectable drug delivery devices for biologics and/or some small molecules within Teva’s Global R&D organization.  At both a strategic and hands-on, tactical level, you will be responsible to manage and execute engineering activities and items including, but not limited to: defining: project strategies, design & development planning and timeline development, resources requirements (internal and external), risk assessment and management, equipment requirements, project and design inputs, outputs and financial requirements, design review, verification testing, validation, human factors, transfer to manufacturing etc..  You will also ensure that external device developers and suppliers meet timelines and adhere to Quality requirements and expectations, GMPs, relevant industry standards, appropriate pharma and device regulations, and control the acceptance and maintenance of device documentation.  You will lead by influence and technical prowess while working within a matrix organization. This is a working-leadership role.

Responsibilities

KEY FOCUS AREAS

  • Lead engineering efforts for device and combination product development managing your projects with internal and external resources which may not be directly reporting to you.
 
  • Manage relationships with contract design houses, contract manufacturing companies and specialist test houses.
  • Lead the creation of robust and compliant technical and design history documents and files.
  • Author robust and complete regulatory filings to support approval of combination products.
  • Represent your projects and department across the company, frequently presenting to more senior management.
  • Interface with Core and CMC Teams, providing both strategic and tactical input and adjusting project direction and activities as necessary.

 

Some Specific Responsibilities:

  • Lead the evaluation and development and/or selection of primary packaging components for injectable biologics.
  • Develop tactical, detailed project plans and budgets for the development of the device and full combination product.
  • Lead the design and development of drug delivery devices and associated combination products leveraging a complex matrix organization across multiple sites, geographies, time-zones, cultures, etc.
  • Identify, communicate and manage project risks (both safety and business), and challenges.
  • Oversee the generation of methods, specifications, procedures, etc..
  • Identify opportunity to generate intellectual property.
  • Compile documentation in accordance with relevant company and regulatory requirements and expectations.
  • Review detailed design for assembly and manufacture of product
  • Implement transfer of design to manufacture
  • Perform key design reviews at stages as per project requirements and the company’s design control system.
  • Perform product and process root cause analysis and problem solving.
  • Participate in Pre-approval inspection readiness efforts and regulatory inspections as necessary.
  • Plan and support project CapEx activities in collaboration with the Finance Department.

Qualifications

Requirements

B.S. in Mechanical/Biomedical Engineering or similar required with a minimum of 10 years deep experience and proven track record in the development and commercialization of injectable drug delivery devices and Combination Products in the Pharmaceutical and/or Biotech space.  Biotech preferred.   Additional experiences required:

 

  • Deep working knowledge and ability to lead combination product development from concept to commercialization including the integration of drug/device, secondary packaging, labeling, instructions for use and training materials.
  • Deep, understanding of current Primary Packaging requirements for biologics.
  • Strong working knowledge of current standards and regulatory expectations for injection device and combination product development, filing and commercialization.
  • Able to write, review and critique technical drawings, documents and reports.
  • Development of mechanical and/or electromechanical devices/systems.
  • Expert knowledge of GMP, EU and FDA regulatory requirements and FDA Guidance, Quality System Regulation (21 CFR 820), combination product regulations (21 CFR part 4) and EU medical device and medicinal product directives.
  • Expert knowledge of ISO 13485, ISO 14971, ISO 10993, ISO 11608, ISO 11040, and other appropriate standards.  
  • Thorough understanding and demonstration of working knowledge of Risk Management and Human Factors as required for Combination Products.
  • Proficiency in use of project management tools and MS Office Suite.
  • Able to present to large groups and senior management. 
  • Ability to work in a global team environment.

 

Travel Requirements:  Ability to travel globally - approximately 25% or as per project requirements.

 

 

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