Oversight of the Drug Product Operations for the viral vector platform at the Center for Breakthrough Medicine. Supporting all aspects of the Viral Vector Philosophy, Strategy, and Execution Plan to make CBM the best in class CDMO facility. 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.
Oversight of the Drug Product Operations which includes Formulation, Filling, Inspection and Packaging 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 Client Success and Transparency with each program.
Management of the personnel and staffing Plan.
Accountable for training and onboarding. Development and execution of accelerated training program.
Ensuring equipment installation and readiness for operational schedule.
Client Facing to support Tech Transfer and Manufacturing PIP and requests.
Work Seamlessly with Cross functional Team to support New Product Introduction and Continuous Improvement within VV and CBM.
Review and approve batch records, SOPs, validation protocols, and reports related to process and equipment stand up.
Strong knowledge of cGMP and Regulatory Standards.
Support Quality Audits, Supplier Audits, and Regulatory Inspections.
Develop Capacity and Staffing modeling to support Manufacturing Operations.
Develop and Implement Operational Excellence Standards with OE department to ensure all Safety, Quality, Delivery, Cost, Innovation.
Ensure accurate ERP, Inventory, and supply chain execution.
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 VV team.
Ensure timely batch records review and deviation closure to support batch release.
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.
Shopfloor support is required and the candidate must be comfortable with Clean Room gowning and can access and walk the floor daily.
Education & Experience
The ideal candidate is preferred to have a Bachelors Degree in a technical or applicable discipline or equivalent. Masters degree is preferred.
The Ideal candidate is preferred to have 10+ years experience or equivalent.
Strong Knowledge of cGMP 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 teams
Strong Cross Functional Communication or indirect management of a project team is preferred.
Technical Skills and Experience specific to the role:
Visual Inspection (Manual Preferred)
Cold Chain Shipping
Primary and Secondary Packaging
Isolator, RABS, or Equivalent Equipment Technology
Aseptic Process Simulations or Media Quals.
Automated Recipes, PLCs, HMI, and/or SCADE Delta V, Wonderware, etc.
Smoke Studies, Aseptic Air Flow
Sterile Gowning and Aseptic Technique