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Assoc Manager, Upstream Manufacturing

Date: Aug 5, 2022

Location: West Chester, US, 19380

Company: Teva Pharmaceuticals

Who are we?

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

Position Responsibilities: 

  • On-the-floor supervisor for all upstream operations. Primarily focused on vial thaw, seed expansion, and large scale activities.
  • Operates and maintains production equipment as it relates to the cell culture process – including analytical instrumentation to support upstream activities and in-process testing. 
  • Leads or performs a variety of complex tasks under general guidance and in accordance with cGMPs.
  • Responsible for drafting of batch records and SOPs, executing, documenting and reviewing data, and review and approval of manufacturing documents according to cGMP guidelines.
  • Acts as the lead investigator, reviewer, and approver for deviations and assesses product quality impact.  Through this responsibility creates an investigation team with colleagues and coordinates team meetings and tasks to identify a root cause and determination of CAPAs.
  • Change owner for implementation or revision of equipment, documentation, and material specifications; initiation, execution, and closure of change controls and CAPA’s.
  • Maintains daily work schedule and assigns daily tasks to associates.
  • Takes the lead on the production floor with planning of activities and provides guidance and training and coaching to senior and junior staff on execution.
  • Proposes and executes implementation of improvements to optimize manufacturing processes. Monitor processes and results and suggests methods to ensure process success.
  • Develops effective working relationships with both internal and external partners.
  • Works with direct reports on development and maintaining performance objectives.
  • Assists and acts as an SME in audits from internal or external partners.
  • 1st shift and/or possible swing shift, if necessary to meet manufacturing process schedule; occasional off shift work and weekend / holiday work will be required. On-call required for acknowledging alarms from equipment during off shift hours.
     

Qualifications

Required Qualifications:

  • BS/MS degree with a minimum of 6 years of experience in the upstream cell culture process for monoclonal antibodies with team lead / supervisory experience.
  • Experienced with manufacturing of drug substance following SOPs and batch records within a cGMP regulated environment.

Preferred Qualifications:

  • Ability to observe technical issues and direct and lead troubleshooting of process and equipment problems.
  • Ability to operate with minimal supervision of complex systems and equipment and optimizes their use in manufacturing in accordance with the cGMPs.
  • Ability to work on complex assignments of diverse scope and ability to exercise judgment within defined procedures and practices to determine appropriate actions.
  • Demonstrated ability to mentor and train colleagues.
  • Lean Six Sigma experience and/or certification

Function

Sub Function

Reports To

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.

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.


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