Associate Director, Project Management Biologics CMC Lead

Teva Pharmaceuticals USA
Job Location
West Chester, PA 19380
Job Description

Located in West Chester, PA, Teva Biopharmaceuticals, USA is accountable for the development and oversight of all CMC aspects related to Biologics programs at Teva. Teva Biopharmaceuticals, USA is a division of Teva Pharmaceuticals, with over $20 billion in annual revenue. The rapidly growing staff of Biologics CMC, specializes in the development of innovative biologics, biosimilars, and extended half-life bio-betters. We currently are developing products in various stages of clinical development from IND through BLA filing. TBU combines the financial stability of a large company with a small-company mentality emphasizing scientific-rigor and flexibility within a Regulatory and Quality context. 

Special Requirement: 
This role requires significant Biologics Science background with experience managing cross functional biologics CMC Projects and Teams. 

The Associate Director of CMC Project Management reports to the Sr. Director of Global Biologics R&D will be a key talent responsible for the implementation of the CMC development strategy across multiple Biologics programs spanning from pre-IND through BLA filing. The Associate Director 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. 

• Serve as the primary Biologics CMC interface with Teva global program leaders communicating CMC project team plans and updates against the approved work plan. Act as the single CMC representative accountable to Project Teams for all CMC aspects (strategic and operational) for assigned projects 
• Lead cross-functional CMC Teams for assigned projects and ensure team focus and accountability to achieve goals and deliverables. Lead development of the CMC plan (activities and timelines) and ensure proper integration and alignment with the overall project plan. Develop and maintain comprehensive Gantt charts in MS Project covering all CMC activities through BLA for multiple clinical development 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 
• 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 relevant Teva governance bodies including Technical Review Committee (TRC), Pharmaceutical Development Committee (PDC), and other review/oversight committees (internal and external) as required 
• Ensure coordination with Operations to align efforts with commercial supply strategy and the targeted commercial scale of manufacturing


Qualifications Education 

•BS/MS or PhD preferred or other advanced degree in a relevant technical discipline (e.g. Biochemistry, Microbiology, Biochemical engineering) 
•Project Management Professional (PMP) certification is a plus. 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 

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