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Associate Director, Manufacturing Science and Technology (MS&T)

Date: Aug 12, 2019

Location: Parsippany, New Jersey, US, 07054

Company: Teva Pharmaceuticals

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!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. For more information on Teva, check us out at www.tevapharm.com or www.tevausa.com

 

Job Description

 

Position Summary:  

You will leverage your subject matter expertise in sterile formulations, processes and technologies and your experience in aseptic manufacturing to oversee activities at Teva’s network of contract manufacturers.  You will drive product robustness for all products in area of responsibility and lead validation and process activities for products developed and manufactured at outside contract  facilities.  This position may be based at Teva’s Parsippany, NJ headquarters or West Chester, PA site.

 

Key Responsibilities 

  • Provide product stewardship by ensuring the performance of all Teva products are monitored and maintained in a validated state
  • Support root cause investigations by providing technical intelligence to deviations, technical complaints, OOS & CAPAs.
  • Identify and execute continuous improvement opportunities and quality improvements
  • Lead New Product Launch technical teams and lead technical activities related to transfers of Drug Product Manufacture and Packaging
  • Work in close collaboration with the TPO MS&T (Third Party Operations Manufacturing Science and Technology) Regional Lead and TPO MS&T Global Head to ensure all applicable global initiatives are implemented within the region in line with the MS&T vision and mission
  • Support due diligence activities for selection of new suppliers
  • Participate in the R&D – Site Handshake process and adopt end to end product stewardship in line with QBD principles and practices to ensure products moving through the pipeline are ready for commercial launch.
  • Drive technology based subject matter expertise
  • Ensure key projects such as launches, API changes, tech transfers and product/process remediation are delivered on time, on budget and meet the target success criteria
  • Provide project team support and functions as a key member of the Supplier Relationship Team

Qualifications

Education

  • Bachelor’s Degree in Applied Science,  Chemistry, Chemical Engineering, or related pharma/scientific discipline required
  • Masters or PHD in Pharma, Science or Engineering preferred

 

 

Required Experience    

  • Minimum 5 years related pharmaceutical  experience including R&D, manufacturing, validation, product transfer, analytical/ process engineering with a strong working knowledge of GMP and US FDA regulations, SOPs, and  current industry standards
  • Must be a Subject Matter Expert (SME) in Sterile Technology
  • Experience with aseptic manufacturing including PST (Process Simulation Test) with media fill, sterilization and decontamination techniques (sterile cleaning, sterilization in autoclave, VHP, dry fogging), CIP, SIP, filtration, housekeeping in sterile areas, glove management requirements,  and aseptic interventions
  • Experience with lyophilization, including basic knowledge of the equipment and cycle development red.
  • Experience writing validation/technical protocols and reports
  • Strong working knowledge of experimental design and logic flow criteria with subsequent resolution skills
  • Experience with statistical tools to analyze data and provide technical leadership in the areas of formulation development and process optimization of pharmaceutical products
  • Must be proficient with Microsoft Office applications.
  • Experience translating business directions into successful supplier strategies to support the end result
  • Must be able to travel up to 20% domestically

Function

Manufacturing

Sub Function

Technical Transfer

Reports To

Director, Manufacturing Science and Technology

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, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws.


Nearest Major Market: New York City
Nearest Secondary Market: Newark