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Associate Director, Device Team Lead

Date: Dec 1, 2018

Location: West Chester, Pennsylvania, US, 19380

Company: Teva Pharmaceutical Industries Ltd.

Company Info

Teva is a global pharmaceutical leader and the world’s largest generic medicines producer, committed to improving health and increasing access to quality health solutions worldwide.  Our employees are at the core of our success, with colleagues in over 80 countries delivering the world’s largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we’ve built a promising pipeline centered around our core therapeutic areas.  We are continually developing patient-centric solutions and significantly growing both our generic and specialty medicines business through investment in research and development, marketing, business development and innovation.  This is how we improve health and enable people to live better, healthier lives.  Join us on our journey of growth!

Job Description

Device Team Lead

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.

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.

Qualifications

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.  

Function

Research & Development

Sub Function

Drug Development and Preclinical Studies

Reports To

In process of validation

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.


Nearest Major Market: Philadelphia

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