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 Head of Process Development has overall responsibility for technical product lifecycle management in the Discovery Labs asset pipeline. This includes preparing the business case, as well as, the oversight and management of technology transfer (new product introductions) into Manufacturing. Developing Life Cycle strategies and plans, including clinical and commercial phases, process improvements and post approval commitments. The individual will be accountable for the successful execution of the corresponding plans in compliance with Agency and Industry Guidance. During the clinical/commercial manufacturing preparation phase, this role will lead the delivery of all pre-run deliverables such as Materials List, Process Transfer Documents, Manufacturing Batch Records, Process Monitoring plans, etc.
• Lead and oversee all process and analytical transfers to and from internal and external business partners.
• Own and execute Quality by Design (QbD) for programs.
• Leverage all of The Center for Breakthrough Medicine’s process development expertise to support late stage clinical programs.
• Responsible for the development schedule adhering to appropriate level of documentation, budget, schedule, and safety commitments.
• Support the commercial function in the assessment of new opportunities and provide appropriate Technical and programmatic input to prospective customers, including the demonstration of capability at customer visits.
• Build, hire and develop a team of PhD & non-PhD staff that has the capability to design, plan, and execute experiments to develop and understand processes for production of therapeutic proteins.
• Make decisions, based on the professional judgment, experience, budget, cGMP regulations, and the ethical guidelines of good business practices.
• Proactively develop and sustain strong relationships with current customer accounts and contractual services suppliers to the unit.
• Evaluate the functional strengths and developmental areas in the Process Sciences team and drive a culture of continuous improvement.
• Manage team of senior managers and professionals within Process Sciences. Hires and develops employees within the department in support of site objectives. Assigns work, provides feedback and coaching, and takes necessary disciplinary actions.
• Work with internal stakeholders in manufacturing, process development & optimization, project management etc. to facilitate successful customer management.
• Independently review the design, execution, data and reporting on the development work completed within the Process Development group. Is expected to resolve (or have resolved) all technical issues.
• Key input into the development of manufacturing platforms and novel technologies.
Experience and Qualifications:
• Ph.D. in biochemical engineering or biological sciences with 15-20 years experience required.
• Solid foundation in the fundamentals of biochemical engineering and cell biology.
• Entrepreneurial experience dealing with customers in product development.
• Working knowledge of cGMPs related to the production of microbial therapeutics.
• Ten to fifteen years of development and scale-up experience.
• Experience with microbial fermentation technologies, protein purification, protein characterization, and downstream processing are essential.
• Ability to work by influencing peers and their reports and gain their cooperation in dealing with multiple priorities in the delivery of projects.
• Strategic leadership and conceptual thinking to ensure that a cost-effective organization is put in place and developed.
• Rational persuasion particularly in the discussions with customers.
• Strong people management and organizational skills; ability to prioritize and manage through complex processes/projects.
• Ability to interpret and manipulate data, define problems, establish facts, draw valid conclusions and make decisions.
• Ability to deal with abstract and concrete variables in situations where only limited standardization exists.
• Extremely high levels of initiative and tenacity.
• Excellent oral and written communication skil