1+ months

Associate Director, Manufacturing Science & Technology

Parsippany, NJ 07054
Company Info

Teva is a global pharmaceutical leader and the worlds 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 worlds largest medicine cabinet to 200 million people every day. We offer a uniquely diverse portfolio of products and solutions for patients and we have 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!

 

We offer a competitive benefits package including Medical, Dental, Vision and Prescription coverage starting on the first day. We also offer Disability and Life Insurance, Paid Time Off, 6% match on the 401(k), Employee Stock Purchase Plan and Tuition Assistance.

 

This position is located in Parsippany, NJ 

Job Description

 

The Associate Director, Manufacturing Science & Technology works with internal and external manufacturing partners as well as local and international Teva R&D sites to support ongoing commercial manufacture of in-line products and development and launch of new products for multiple device-based drug delivery systems (drug injection, nasal spray, transdermal, inhalation). The position will be the primary technical lead for product quality investigations, and expected to coordinate with local and international teams within Teva to complete investigations, as well as lead implementation of process solutions with internal and external partners.

 

The incumbent expected to take an active role in collaborating with R&D and GMS&T from conception to launch in order to ensure robust commercial manufacturing. During product development, the engineer will work hand-in-hand with R&D partners to select CMOs and develop a robust product and process that is capable of be commercialized.  Additionally, the incumbent will oversee Process Failure Modes and Effects Analysis (pFMEA), and Design for Manufacture (DFM) and Design for Assembly (DFA) activities. The incumbent will participate in assessments of CMOs, CDOs, and other external business partners for initial selection, as well as for ongoing business and product reviews with selected third parties. The job will require oversight of PPQ activities at CMOs, including defining a validation strategy and overseeing protocol preparation and execution, to ensure the product is being produced within a validated state. Additional responsibilities will also include reviewing documents to support in-line products including change controls, manufacturing investigations, CAPA implementation plans and effectiveness checks.  


Travel Requirements:  


Up to 30%.  Must have ability to travel internationally.  Ability to travel long distances, including extensive air travel could be intermittently required.   

 

Essential Duties & Responsibilities: Percentage of Time -

 

1.    Serve as technical leader for third party device manufacturing, device investigation and implementation of process solutions    40%
2    Actively participate in creation and review of risk management documents    10%
3.    Participate in IQ/OQ/PQ activities including the drafting or review of protocols and validation reports.    10%
4.    Participate in selection and qualification of device CMOs.  Travel as required    10%
5.    Work with project leaders and both internal and external team members to ensure proper DFx for commercialization of new products    20%
6.    Create process and equipment documentation for improvements and initial installation    10%
 

Qualifications
  • Bachelors Degree in science, engineering, or technical field.  
  • Minimum six (6) years experience in the medical device and/or combination products field as a device engineer
  • Working experience of medical device GMP Quality Systems and related requirements (FDA 21 CFR820, ISO 13485) is required.
  • Medical device/combination product industrial and/or design control experience.
Function
Manufacturing
Sub Function
Technical Transfer
Reports To

Director, MS&T 

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply: Internal Career Site

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Categories

Posted: 2020-08-18 Expires: 2020-10-16

Join us at the forefront of pharmaceutical research and production. With state-of-the-art facilities, highly skilled colleagues, and a high-powered organizational culture, Teva offers you countless possibilities to make a real difference in people's lives and add value to your career.

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Associate Director, Manufacturing Science & Technology

Teva Pharmaceuticals
Parsippany, NJ 07054

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