The Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.
CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.
CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.
The Discovery Labs is a Global Platform Company inclusive of CBM, The Discovery Labs Properties, UniteIQ incubator labs, and The Colony, a unique investment and resource model enabling groundbreaking therapies to be brought to life.
The Project Manager, Process Development is a hands-on, cross-functional leader with a passion for driving results in a dynamic customer-focused environment. This key leadership position is accountable for operational leadership of a cross-functional team and collaborates with internal and external key stakeholders to drive results for customer projects. The Project Manager possesses a scientific background, including laboratory and/or API/Drug Product manufacturing in a GLP/GMP environment. A working manager, this coach and leader is the liaison for key strategic accounts and responsible for all assigned personnel management and project deliverables. The position requires superior leadership behaviors of Center for Breakthrough Medicine’s core competencies and non-negotiables, as well as expertise in the functional competencies associated w/ the business unit assigned.
- Provides operational leadership to a cross-functional team for customer projects in external collaborations, laboratory services, and/or manufacturing in a GLP/GMP environment
- Collaborates with internal and external key stakeholders to drive superior results for an assigned portfolio of customer projects
- Serves as the liaison for key projects and is responsible for all assigned personnel management, daily project management, oversight and key deliverables of an assigned portfolio of projects
- Assists to procure resource assignments from appropriate departments and managing scope of work definition with responsible project managers, including escalations
- Establishes and oversees overall project plans, scope and work plans throughout the project life cycle
- Manages a cross-functional project lifecycle including customer interactions, scheduling, resource allocation, and finances while providing key updates to leadership
- Ensures timely and effective communications with business units and leadership teams
- Fosters a positive customer experience and relationship
- Engages in strategy decisions with Operations, Commercial and Quality teams, and drives metric reporting and continuous improvements
- Develops, monitors, and ensures that global Key Performance Indicators (KPIs) are being fulfilled
- Actively engages in and supports business development efforts through ongoing contact with assigned customers and project scoping
- Ensures collaboration with appropriate team members across different functions for driving business decisions and client communications
- Ensures timely completion and compliance with SOPs and cGMP compliance and all other relevant company training requirements
- Fosters a high performing cross-functional team through effective selection, training, and development, coaching and mentoring and performance management
- Bachelor’s degree in a scientific or engineering discipline required; Master’s degree preferred
- 7 years of related pharmaceutical experience required, including relevant experience in laboratory services, and/or manufacturing in a GMP environment
- 2 years of project management experience managing multi-disciplinary project teams in a service business required
- 2 years of prior supervisory or managerial experience preferred
- Advanced formal training, degree or certification(s) preferred
- Excellent leadership, written and verbal communication skills and ability to influence others
- Excellent critical thinking and problem-solving skills
- Detailed and results orientated
- Excellent negotiation and facilitation skills, with strong customer-service focus
- Able to professionally handle multiple and sometimes competing priorities
- Strong aptitude for technical comprehension enabling rapid learning in a highly regulated environment
- Ability to lead multi-disciplinary project teams
- Strong understanding of pharmaceutical product development and manufacturing
- Strong knowledge of FDA regulation/ICH guidelines, U.S. drug development process and project management practices
- Proficiency in Microsoft Office programs including Word, Excel and MS Project
- Proficiency with ERP, CRM, and Documentation Systems
- Ensures accuracy and relevance of assigned training curriculum
- Drives timely completion of training for employees to meet regulatory requirements
- Performance Management, coaching, mentorship, and development of employees