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Project Management Lead, CMC Biologics Product Development

Teva Pharmaceutical


Location:
West Chester, Pennsylvania 19380
Date:
08/08/2017
2017-08-082017-09-07
Job Type:
Employee
Job Status:
Full Time
Teva Pharmaceutical
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Job Details

Project Manager Lead, CMC Biologics Product Development

Clinical Manufacturing

 

Located in West Chester, PA, Teva Biopharmaceuticals, USA is responsible for the development of CMC Biologics. Teva Biopharmaceuticals, USA is a division of Teva Pharmaceuticals, with over $20 billion in annual revenue.  The rapidly growing staff of Biologics CMC, now nearly a hundred, 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.

 The Project Manager CMC Biologics Lead will be responsible for leading multiple CMC Teams spanning from pre-IND through BLA filing. This includes, but is not limited to, implementation of the CMC development strategy, adherence to Stage Gate process and approval by governance bodies, the identification and mitigation of CMC risks, creation and adherence to budget and timelines, technical content for IND and BLA filings, and the delivery of clinical drug supplies in accordance with development plans.  The Project Manager CMC Biologics lead is the single CMC representative accountable to Project Teams for all CMC aspects (strategic and operational) for assigned projects.   

The Project Manager CMC Biologics Lead will have demonstrated team leadership skills (as a team member or a team leader) and experience working in a multi-disciplinary, highly matrixed environment, with evidence of delivering results in this setting, including: in-depth experience and technical knowledge of the CMC Biologics development process. The incumbent will have demonstrated Biologics drug development experience in one or more areas of CMC.  Importantly, the incumbent will serve as key interface with Clinical, Non-Clinical, Regulatory Affairs, and Operations colleagues on Global Project Teams.

 MAJOR DUTIES AND RESPONSIBILITIES

Lead cross-functional CMC Teams for assigned projects and ensure team focus and accountability to achieve goals and deliverables

Act as the single CMC 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

 

Requirements

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 preferred

 Professional Experience

For Manager Level:   5 plus years pharma/biotech industry experience with deep technical experience in one or more areas of CMC development

For Sr. Manager level: 7 plus years pharma/biotech industry experience with deep technical experience in one or more areas of CMC development

For Associate Director level: 10 plus years pharma/biotech industry experience with deep technical experience in one or more areas of CMC development.

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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