CBM

Full Time EE - Onsite

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.

Summary

Cell and Gene Therapies Drug Product Development (CGDPD) is a department within a Process Development Division in Center of Breakthrough Medicines. CGDPD is responsible for drug product formulation, process development and tech transfer for manufacturing of various modalities of allogeneic and autologous cell and gene therapies. CGDPD represents a unique diverse team of scientists and engineers driving end-to-end Drug Product development efforts in advanced therapies. Director, Drug Product Development Head will play a critical role critical role in leading formulation, in-use stability and process development studies for clinical and commercial cell and gene therapy drug products. This role encompasses support of early phase development as well as late-stage BLA work packages in support of commercialization of clients’ products. The successful candidate will be responsible for driving various activities, including, but not limited to described below:

Responsibilities

• Manage a team of scientists and engineers to develop, optimize and implement formulation and manufacturing process for cell and gene therapy drug products.
• Drive innovations through evaluation of novel cell and gene therapy DP formulation and manufacturing approaches, identification of new instrumentation and testing of emerging platforms.
• Plan, oversee and interpret formulation development experiments for various modalities of cell therapies such as CAR-Ts, CAR-NKs, TILs, Tregs, iPSC and others.
• Plan and execute studies to understand and control interaction of DP with product contact material surfaces in manufacturing and clinical settings.
• Develop robust manufacturing process and scale up procedures for engineering and GMP DP batches by applying QBD approaches as per Health Authority requirements.
• Author/review technical reports, data summaries and CMC related documents required for regulatory submissions.
• Design and support container closure selection and development for cell and gene therapies.
• Lead technical discussions aimed at resolution of issues with suppliers, processes, and deviations
• Interface with clients to establish/maintain a positive relationship, ensure expectations are clear, plan for right-first-time execution, and complete studies to successfully deliver against the program
• Ability to work under pressure and deliver high quality clinical trial and manufacturing batches.
• Works closely with tech transfer team to make sure that DP manufacturing processes meets requirements of target product profile.
• Other duties as needed.

Qualifications

• Thorough understanding of formulation and process development for novel modalities.
• Proven track record in building and leading diverse development teams in innovator pharmaceutical companies and CDMOs is must.
• Experience with authoring regulatory documents for IND/IMPDs and BLAs
• Excellent verbal and written skills, allowing for an open and effective dialogue throughout the company.
• Attention to detail and quality are critical to success.

Education & Experience

• Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or equivalent life sciences field with 10+ years’ experience, MS with 15+ years, BS with 17+ years.