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.
Oversight of the New Product Introduction, Campaign Readiness (CR) and Continuous Improvement (CI) Department of the Viral Vector (VV) Manufacturing platform at the Center for Breakthrough Medicine (CBM). Supporting all aspects of the Viral Vector Philosophy, Strategy, and Execution Plan to make CBM the best-in-class Contract Development and Manufacturing Organization (CDMO). Viral Vector will make up the largest revenue generating platform with over 15 High Throughput Suites and 5 manufacturing floors. This will include stand up of the organization, hiring, onboarding and training, development of processes and work streams, and equipment installation and qualification. Following stand up; this candidate will be responsible for the tactical and strategic management of Operations but must also contribute to other functions of the platform and company.
This is a dayshift position, reporting M-F however the candidate must be able to be flexible to support 24/7; especially during critical validation or operational times.
- Oversight of the New Product Introduction, Campaign Readiness and Continuous Improvement of Viral Vector.
- Support and maintain a culture of Safety, Quality, Delivery, and Operational Performance based on CBM Goals and Vision.
- Maintain Cost Mindfulness and promote Innovation and Team work to meet or exceed Revenue and EBITDA targets.
- Drive Batch Success and Transparency with each VV program.
- Management of Manufacturing Project Lead Organization and staffing Plan to ensure success and on time delivery of Technology Transfer deliverables.
- Accountable for training and onboarding of Manufacturing Project Leads.
- Ensures timely completion and compliance with SOPs and cGMP compliance and all other relevant company training requirements
- Client Facing to support Tech Transfer, Person-In-Plant(PIP) communication and client requests.
- Work Seamlessly with Cross functional Team (Internal and External Stakeholders) to support New Product Introduction and Campaign Readiness within VV and CBM.
- Accountable for the creation of batch records, SOPs, risk assessments, validation protocols, and validation reports related to process and equipment stand up.
- Ensures timely and effective communications with business units and leadership teams
- Strong knowledge of cGMP and Regulatory Standards.
- Support Quality Audits, Supplier Audits, and Regulatory Inspections.
- Develop Capacity Model to support NPI, CR CI requirements for VV
- Work closely with Process Development to execute on Time Technical Transfer of new or optimized programs.
- Develop and Implement Operational Excellence Standards with OE department to ensure all Safety, Quality, Delivery, Cost, Innovation.
- Drive Talent Development and Retention by ensuring development plans are in place for the VV organization and a clear performance ladder is in place for NPI/CR/CIteam.
- Ensure detailed project planning for Technology Transfers/Campaign Readiness and on time start dates for all VV programs.
- Support Quality Change Control Requests, CAPAs, and all supporting documents for NPI, CR and CI in VV.
- Support Internal and External Audits.
- The ideal candidate is preferred to have a Bachelor’s Degree in a technical or applicable discipline or equivalent. Master’s degree is preferred.
- The Ideal candidate is preferred to have minimum 10 years’ of related experience in cGMP Manufacturing.
- Strong Knowledge of cGMP principles or Commercial Biopharma experience.
- Regulatory experience with FDA, EU is Required. Clinical also a plus.
- Knowledge of SAP or equivalent ERP systems.
- Multiple years of experience with people management and building of high performing teams
- Strong Cross Functional Communication or indirect management of a project team is preferred.
- Technical Skills and Experience specific to the role:
- Upstream Processing (Cell Culture, Expansion, Transfection/Infection of Cells).
- Downstream Processing (Purification, Column Chromatography, Ultra Centrifugation, Filtration).
- Drug Product Processing (Formulation, Aseptic Filling, VI, and Packaging).
- Buffer and single use component preparation and sterilization.
- Technical Transfers
- Equipment and Material Procurement
- Detailed Project Planning
- Cross Functional Team Management
- Document Creation
- Quality Change Controls, CAPAs, Deviations
- Risk Assessment Execution.
- Problem Solving and Innovation Programs
- Change Management