CBM

Full Time EE - Hybrid

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

Center for Breakthrough Medicines is seeking a VV Manufacturing Project Specialist for the execution of Technology Transfer for New Product Programs and Campaign Readiness Activities within the organization’s VV Manufacturing platform. The role will support all aspects of the Viral Vector Philosophy, Strategy, and Execution Plan to make Center for Breakthrough Medicines (CBM) a best-in-class Contract and Development Manufacturing Organization (CDMO).

Responsibilities

• Execution and oversight of Technology Transfer activities for designated New Product Programs and deliverables for VV Manufacturing
• Maintain a culture of Safety, Quality, On-Time 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
• Strong focus on batch success and transparency with each assigned program
• Participate as a key member of the Program Project Teams, working cross-functionally to complete deliverables on time in full
• Escalate issues that would jeopardize the Program, timeline, and milestones
• Development and review of batch records, SOPs, training modules, bill of materials, and Process Development milestones for tech transfer projects
• Own CAPAs, Change Controls, and Deviations as required
• Drive on-time batch release
• Assist and participate in the clean room execution as new programs launch
• Ensure equipment installation and readiness for operational schedule
• Client Facing to support Tech Transfer, Person-In-Plant (PIP) communication and client requests
• Work closely with Process Development to execute on-time technical transfer of new or optimized programs
• Support Quality Audits, Supplier Audits, and Regulatory Inspections
• Support new equipment on-boarding through review and approval of IQ/QQ/PQ documents
• Follow Operational Excellence Standards with department and company goals in mind
• Ensure detailed project planning for tech transfers and on time start dates for all programs

Qualifications

• The ideal candidate is preferred to have a Bachelor’s degree in a technical or applicable discipline or equivalent.
• The ideal candidate is preferred to have minimum 2+ years experience or equivalent
• Regulatory experience with FDA, EU Commercial and Clinical Manufacturing is preferred
• Knowledge of SAP or equivalent ERP systems
• Strong Cross Functional Communication skills
• Strong knowledge of Bio-Manufacturing, cGMP, and Quality Standards
• Shopfloor support is required, and the candidate must be comfortable with Clean Room gowning and can access and walk the floor daily
• 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
• Candidate must be prepared for an exciting, dynamic, and fast paced CDMO/start up environment

Technical Skills and Experience preferred for the role:

• Upstream Processing (Cell Culture, Cell Expansion, Transfection/Infection of Cells)
• Downstream Processing (Purification, Column Chromatography, Ultra Centrifugation, Filtration)
• Drug Product Processing (Formulation, Aseptic Filling, Vial Inspection, and Packaging)
• Solution preparation and single use component preparation and sterilization
• Technical Transfers
• Equipment and Material Procurement
• Detailed Project Planning
• Document Creation
• Quality Change Controls, CAPAs, Deviations
• Participation in Risk Assessments
• Problem Solving

As an Equal Opportunity Employer, we believe in each person’s potential. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, sexual orientation, gender identity, disability or any other protected category including veteran status.