1+ months

AD, Pharmaceutical Manufacturing (Aseptic)

Irvine, CA 92606
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

Teva is searching for an Associate Director, Aseptic Processing and Component / Equipment Preparation to join our team in Irvine, CA!

This role is responsible for managing and directing staff to ensure proper and continuous function of the Aseptic Filling and Lyophilization operations.

As the AD, Aseptic Processing, you will ensure that all operations of the Aseptic Processing areas are performed in accordance with cGMP guidelines as well as applicable Teva CORP SOPs.

 

You will:

  • Direct personnel to perform catching, loading, and off-loading of product into autoclave trays/trucks or bulk boxes, and ensure Product Catching areas are kept in accordance with cGMP guidelines and applicable Teva SOPs.
  • Support the production schedule in terms of staffing, work schedules, planning activities, and equipment preventative maintenance.
  • Ensure personnel perform aseptic filling of pharmaceutical products and cleaning / sanitization of aseptic areas.
  • Work closely with QC Chemistry, Microbiology and Scheduling to provide a smooth and efficient workflow.
  • Provide support to MS&T in the development of new product processes including the filling and accountabilities sections of batch records.
  • Ensure personnel complete and review all filling, bulk solution accountability, yield batch record documentation, and histograms.
  • Perform / support investigation and completion of process investigational reports.
  • Provide support to MS&T teams for new product development in the area of aseptic filling, vial wash, vial depyrogenation, lyophilization and terminal sterilization processes.
  • Write new SOPs and amend current SOPs to accurately cover all significant activities within the department.
  • Coordinate technical assistance for MS&T and Engineering protocols, coordinate activities for process enhancement projects and support new product development projects. 
  • Prepare and monitor the annual department budget.
  • Ensure that weekly and monthly inventories are performed.
Qualifications
  • Bachelors Degree in Science, or related fields preferred; equivalent experience may be accepted in lieu of degree.
  • Minimum of five years of experience managing others both directly and indirectly required.
  • Minimum of ten years pharmaceutical industry experience preferred.
  • Sterile/aseptic manufacturing experience required. LEAN experience a plus.
  • Strong cGMP background in a commercial manufacturing environment (sterile parenterals).
  • Strong mechanical background with knowledge of formulation processing and related equipment.
  • Working knowledge and experience in product scale-ups and new product introduction.
  • Experience with Root Cause analysis, and investigative writing required.
  • Working knowledge of environmental monitoring. Background in RABs and barriers protection.
  • Working knowledge and experience in the execution of air flow studies.
  • cGMP background and working knowledge / experience, Oil based products, Water based products, and Solvent based products
  • Strong mechanical background manufacturing suspension product, and working knowledge and experience in supply chain.
Function
Manufacturing
Sub Function
Manufacturing/Operations
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: 2020-05-18 Expires: 2020-09-09

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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AD, Pharmaceutical Manufacturing (Aseptic)

Teva Pharmaceuticals
Irvine, CA 92606

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