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Associate Director, CMC Project Management

Date: Oct 8, 2021

Location: West Chester, Pennsylvania, US, 19380

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!

Job Description

As the Associate Director of CMC Project Management you will report to the Director of CMC Project Management and be a key talent responsible for the implementation of the CMC development strategy across multiple Biologics programs spanning from pre-IND through BLA filing.  

 

You will be responsible for coordinating the cross functional CMC teams with broader global project teams serving as the key interface with Clinical, Non-Clinical, Regulatory Affairs, and Operations colleagues on Global Project Teams. Furthermore, you may also have the responsibility of leading projects related to the medicinal chemistry of drug discovery. 

 

The position requires project management skills for the timely completion of departmental and corporate goals. 

 

As the Associate Director you will define all CMC activities required for implementation of the Product Development Plan and ensure alignment with business objectives.  You will develop Product Definition and CMC Strategy documents with appropriate input from cross-functional team members and you will collaborate with functional representatives to anticipate and identify project risks and develop action and resolution plans.

 

Other duties:

  • Maintain the CMC plan and timelines; monitor and control deliverables, budget and scope
  • Establish and maintain effective communication channels to provide accurate information to the CMC Biologics leadership team, functional line management, Project Team leadership, and management
  • Prepare status reports for updating senior management and creation/maintenance of internal team documents
  • Interface with Technical Review and Project Governance Committees (internal and external) as required
  • Ensure coordination with Operations to align efforts with commercial supply strategy and the targeted commercial scale of manufacturing
  • Responsible for generating and updating annual operating plan/budget and long range forecasting models

Qualifications

What you will bring to the role:

  • Bachelor’s degree in Chemistry, Biology, or other scientific or health related field of study
  • Minimum 10 years of experience in the pharmaceutical industry, relating to CMC biologics development. 
  • Minimum of 3 years of experience in project management or leading cross-functional teams 

 

Preferred Qualifications:

  • Advanced degree in Science / Business 
  • Project Management Professional (PMP) certification 
  • Experience leading global and/or virtual teams
  • Direct experience with CMC technical content for regulatory submissions
  • Experience with discovery to early-stage CMC development of small-molecules
  • Experience with early-stage CMC development and clinical manufacturing of biologics 

Function

Research & Development

Sub Function

Pharma R&D Project/Program Management

Reports To

Director, CMC Project Management

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. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.  


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