1+ months

Associate Director, CMC Leader, Biologics

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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

Responsibilities:

  • Lead cross-functional Teams for assigned projects and ensure team focus and accountability to achieve goals and deliverables
  • Act as the departmental  representative accountable to Project Teams for all CMC aspects (strategic and operational) for assigned projects
  • Define all CMC activities required for implementation of the Product Development Plan and ensure alignment with business objectives
  • Develop the Product Definition and CMC Strategy documents with appropriate input from cross-functional team members
  • Collaborate with functional representatives to anticipate and identify project risks and develop action and resolution plans
  • Lead development of the CMC plan (activities and timelines) and ensure proper integration and alignment with the overall project plan
  • 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 monthly status reports, internal team documents
  • Interface with the Technical Review Committee (TRC), Pharmaceutical Development Committee (PDC), and other project governance bodies (internal and external) as required
  • Ensure coordination with Operations to align efforts with commercial supply strategy and the targeted commercial scale of manufacturing
  • Prepare monthly status reports, internal team documents
  • Interface with the relevant Teva governance bodies including Technical Review Committee
  • Responsibility for generating and updating annual operating plan/budget and long range forecasting models
  • Coordinate with Teva Global Finance to supply LBEs (last, best estimates) of project budgets twice per quarter   

Professional Experience:

  • 10+ years pharma/biotech industry experience with deep technical experience in one or more areas of CMC development with at least 3 years in project management
  • Direct and broad experience in cross-functional CMC biopharmaceutical product development is required
  • Experience with early-stage CMC development and clinical manufacturing of biologics is strongly preferred
  • Experience leading global and/or virtual teams is highly preferred
  • Direct experience with CMC technical content for regulatory submissions is preferred

 

 Skills/Knowledge/Competencies:

  • Working knowledge of all phases of drug development
  • Demonstrated strong understanding of project management principles applicable to the biopharmaceutical environment
  • Excellent communication skills, both oral and written, as well as proven conflict management and negotiation skills
  • Demonstrated ability to balance scientific, technical, and business objectives
  • Demonstrated leadership skills are required
  • Excellent interpersonal skills with the ability to adapt effectively to rapidly changing organization issues, structures, and dynamics
  • Demonstrated ability to work with cross-functional teams in a matrix environment and influence stakeholders is required
  • Demonstrated ability to make difficult decisions in a timely fashion along with excellent follow through and organizational skills to assure team and organizational alignment to these decisions
  • Advanced planning and monitoring skills with strong attention to detail including direct experience with project management tools (e.g., Microsoft Project)
  • Demonstrated capability to efficiently managing multiple concurrent programs
  • Well-organized with ability to effectively prioritize

 

 

Education:

  • Advanced degree in a relevant technical discipline (e.g. Biochemistry, Microbiology, Biochemical engineering)
  • Project Management Professional (PMP) certification is preferred

Posted: 2020-06-05 Expires: 2020-08-31

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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Associate Director, CMC Leader, Biologics

Teva Pharmaceuticals

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