Program Manager, Manufacturing

**Description**

A Program Manager, Manufacturing is a unique and exciting position that will oversee the next generation MultiStem® manufacturing process based at a Contract Manufacturing Organization (CMO) in Singapore. The Program Manager will be responsible to act as the Subject Matter Expert (SME) of the MultiStem® process and be the first point of escalation for the clinical and commercial manufacturing campaign. This position will report into the Sr. Director of Program & Portfolio Management and closely collaborate with the cross-functional team based at our US Corporate Site in Cleveland, OH.

**Job Functions**
- Act as Person-in-Plant (PIP) to supervise all aspects of next generation manufacturing of MultiStem® process at contract manufacturer for clinical and commercial manufacturing
- Provide day to day technical oversight of the process and analytical related activities at the CMO to ensure robust and reliable product supply for clinical and commercial requirements
- Provide necessary leadership to monitor and assure CMO has required resources to successfully achieve manufacturing program milestones and goals established
- Interface with Technical, Quality, and Regulatory functions at US Corporate Site for batch record review, deviation resolution, change control and all other documentation relating to the manufacture of MultiStem®
- Participate in the development and approval of protocols to support all phases of the manufacturing process. This includes Master Batch Records, Analytical Methods, Validation Protocols, Raw Material Specifications, Quality System Documents, Regulatory Filing Documentation (INDs, CTAs, J-NDA/MAA/BLA), and on-site Regulatory Inspections by Health Authorities
- Initiates change requests within the Athersys Quality System related to the manufacturing and testing procedures to assure technical feasibility/ suitability and quality compliance
- Work with the CMO to establish and manage metrics used to evaluate, monitor, and improve the performance of the CMO
- Monitor and support lot release activities by assuring timely documentation by internal and external stakeholders
- Monitor and investigate product yield related issues
- Implement and manage control charting process for the critical process parameters, critical quality attribute and process yields; Provide routine updates on process performance
- Collaborate with CMO in monitoring key raw material inventories and providing forecast for media production planning and raw material purchase
- Coordinate shipping of final product to clinical and commercial distribution sites
- In collaboration with Athersys Finance organization, establish and manage annual capital and expense budget to support clinical and commercial supply requirements

**Knowledge/Skills**
- Must possess a thorough understanding of biologic or cell therapy manufacturing
- Demonstrated ability to establish good working relationships with third party service providers
- Highly organized with the ability to work independently to prioritize and meet schedules and deadlines
- Excellent communication skills both written and verbal along with good computer skills
- Enthusiasm for a collaborative work culture

**Education/Experience**
- Bachelor’s Degree in a scientific discipline with relevant biopharmaceutical experience, preferably with Cell Therapy Products
- At least 7 years of relevant industrial, biologic, or cell manufacturing experience with exposure to GMP manufacturing and aseptic processing is preferred
- Experience with aseptic cell culture and cell processing equipment

Schedule:

- Day shift