Principal Scientist - DP MSAT

Principal Scientist - DP MSAT

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. CBMs 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. CBMs horizontal and vertical integration provides one source throughout a products life cycle.

CBMs 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, tech transfer and support 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.Drug Product Manufacturing Science and Technology (DP MSAT) is a team within a Cell and Gene Therapies Drug Product Development in Center of Breakthrough Medicines. DP MSAT provides technical support for enabling readiness, robustness and GMP compliance of fill/finish manufacturing processes for gene and cell therapy products. Associate Director of DP MSAT ensures that formulation, fill/finish and cryopreservation steps in drug product manufacturing processes are optimized, scalable and compliant through strong collaboration and guidance from Drug Product Process Development, Quality and Manufacturing teams.

Responsibilities

• Lead and coordinate drug product manufacturing effort between Process Development and Manufacturing organizations.
• Contribute to overarching Process Development goals by ensuring the effective integration of process knowledge into manufacturing operations.
• Work closely with Manufacturing team to ensure that drug product operations are thoroughly supported by high quality process documentation (batch records, forms, SOPs), controlled processes and verified technology.
• Responsible for change control ownership, investigations, and other quality system deliverables.
• Support fill/finish manufacturing processes from early clinical phase through and commercial manufacturing.
• Design and ensure DP process control strategies, including execution of process risk assessment, justification of process parameters range, and criticality analysis.
• Collaborate with Cell & Gene Therapy Drug Product Development and Quality organizations to establish and maintain the control of the process.
• Accountable for DP process FMEA original drafting and revision through drug product life cycle.
• Leverage DP MSAT teams technical knowledge and expertise to lead investigations from initial analysis, root cause determination to establishment and execution of effective CAPAs.
• Provide on-the floor support during engineering and GMP DP manufacturing runs. Prevent and resolve issues taking place during production through use of process analytical technologies and product monitoring.

Required Qualifications:

• Ph.D. in Chemical Engineering, Bioengineering, Biotechnology, or equivalent life sciences field with 7+ years experience, MS with 9+ years, BS with 13+ years
• Proven experience with equipment and manufacturing processes commonly used for allogeneic & autologous cell therapies and fill/finish of viral vectors.
• Robust experience in technology transfer from development into a cGMP Manufacturing.
• Direct experience of working in quality systems, authoring and review of GMP and technical documents.

• Previous experience in facility commissioning, equipment qualification and maintenance is highly preferred.
• Thorough understanding of GMP requirements and their relation to process operations.
• Demonstrated project management capabilities.
• Self-motivated with strong interpersonal and organizational skills.
• Emotional intelligence to communicate and interact internally and with clients to drive program deliverables.

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