Associate Director (m/f/d), Devices & Combination Products, Biologics

Who we are

 

We want to improve the life of our patients. That is our daily mission. We are proud of our 2,900 employees who provide millions of people with essential medicines every day. Health needs a healthy environment - we are committed to this and, as an environmental pioneer in the German pharmaceutical industry, we set our German sites carbon-neutral in 2021. 

 

And that's not all: we are represented in over 60 countries worldwide, the market leader in generics and the home of Germany's well-known pharmaceutical brand ratiopharm. As a full-service provider, we offer a wide range of approximately 3,500 products. These includes innovative medicines, generics, biosimilars and over-the-counter medicines. In our global network, we are constantly developing new, innovative therapies to further improve healthcare for all people. Several teams located at the German site are part of Global and European departments and thus contribute to Teva’s success around the globe.

In a nutshell: We are Teva - and we are very proud of it!

 

If you feel like us and if you are someone who enjoys exploring unknown paths - then we would like to get to know you. Are you also enthusiastic about global markets and pioneering technologies? And would you like to develop the future of healthcare at a leading provider of medicines? Fantastic! Then become part of our team!

Curious about the German site? Fantastic, then take a look: https://www.youtube.com/embed/73i_f4kpfVU?rel=0&showinfo

A day as Associate Director (m/f/d), Devices & Combination Products, Biologics

 

In your new role as Associate Director (m/f/d), Devices & Combination Products, Biologics you will work 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). You will be the primary technical lead for product quality investigations, and you are 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 that are located mostly in EU and Asia/Pacific.
Furthermore, you are also expected to take an active role in collaborating with R&D and Global Manufacturing Science & Technology from conception to post-launch to ensure robust commercial manufacturing. You will work together with different stakeholders to select Contract Development and Manufacturing Organizations (CDMOs) and develop a robust product and process that is capable of be commercialized.  Additionally, you will oversee Process Failure Modes and Effects Analysis (pFMEA), and Design for Manufacture (DFM) and Design for Assembly (DFA) activities. 
You will participate in assessments of CDMOs for ongoing business and product reviews with selected third parties. The job will also require an oversight of Process Performance Qualification (PPQ), 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, Corrective and Preventive Action (CAPA) implementation plans and effectiveness checks. 

Who are we searching for

 

You are

• A trusted and excellent communicator who enjoys leading
• A Well-Organized hard worker that is not afraid of challenges 
• Able to navigate effectively within a cross-functional team environment and interface with colleagues at all levels (Experienced in supporting multi-site and multi-design device/combination product development is preferred)
• Willing to travel  

You have

• A Degree in science, engineering, or technical field, with background in in Mechanical Engineering or Biomedical Engineering being highly desirable
• At least 5 years of experience in the medical device and/or combination products field
• Working experience of medical device GMP Quality Systems and related requirements (FDA 21 CFR820, ISO 13485, other knowledge of device regulations relating to drug injection systems is highly desirable) 
• Medical device/combination product industrial and/or design control experience with emphasis on Device Manufacturing & Assembly Equipment (manual and automated assembly) and Validation requirements including IOQ, PQ, etc.
• Previous experience with drug devices (syringes, auto-injectors, nasal sprays, transdermal patches, inhalers or o