Associate Director, Aseptic Processing and Component / Equipment Preparation

Company Info

If you’re like people at Teva, you dare to be different. We’re making well-being a way of life for our customers and our colleagues. Join us in helping to make healthcare more accessible to more patients, while supporting one of the most innovative teams in the industry.

 

Teva’s Irvine, CA production site is one of our complex manufacturing and supply chain operations.

 

We are strengthening and adding to our critical teams with great talent and capabilities. Teva, a global organization, with a brand of evolving success.  Be part of it!

 

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.

 

 

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:
• Ensure personnel perform equipment / component preparation, aseptic filling and monitoring of sterile injectable and cleaning / sanitization of aseptic areas.
• 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 OEE, daily updates, staffing oversight, personnel accountability is maintained, work schedules are met, planning in collaboration with other production department, and equipment preventative maintenance is planned and scheduled.
• 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 cGMP documentation, ERP transactions, raw materials are cycled, bulk solution accountability executed, yields / batch record documentation, logbooks entries, histograms are performed timely and correctly.
• 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 managed for cost savings staging manufacturing inventories are performed consistently.

Qualifications

 

Requirements:
• Bachelor’s Degree required
• 5 years of experience managing others both directly and indirectly required.
• 10 years pharmaceutical industry experience preferred.
• Sterile/aseptic manufacturing experience required.
• LEAN experience a plus.
• Experience with Root Cause analysis, and investigative writing required.
• cGMP background in a commercial manufacturing environment (sterile parenterals).
• Mechanical background with knowledge of formulation processing and related equipment.
• Knowledge and experience in product scale-ups and new product introduction.
• Knowledge of environmental monitoring. Background in RABs and barriers protection.
• 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
• Mechanical background manufacturing suspension product, and working knowledge and experience in supply chain.
 

Function

Sub Function

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