Executive Director, Commercial Manufacturing Operations Jobs in Philadelphia, PA at Iovance Biotherapeutics, Inc.
Title: Executive Director, Commercial Manufacturing Operations
Company: Iovance Biotherapeutics, Inc.
Location: Philadelphia, PA
Salary: $250K — $500K+*
Category: Pharmaceuticals & Biotech
The Executive Director will be responsible for leading the Commercial Manufacturing into and through the next phase of commercial manufacturing operations for Iovance. This individual will oversee the manufacture of clinical and commercial cell therapy products through both in-house manufacturing and external manufacturing partners. This position will be responsible for the expansion of Iovance’s commercial manufacturing capabilities with CDMO partners and be part of a team to further expand Iovance’s in-house manufacturing capabilities in the Philadelphia region.
This individual will advise and influence Iovance Leadership team on manufacturing best practices (policy, governance, strategic planning, operating model and processes etc.) This role is responsible for planning and executing short and medium range cell therapy manufacturing planning to support Iovance’s commercial launch.
Provide leadership and direction for all aspects of the Operations function for Regulatory licensure activities including representing their areas of responsibility during agency inspections and formulation of inspection responses.
Oversee, either directly or indirectly, Manufacturing investigations, CAPA, process variances and deviations. Ensure that all Manufacturing owned change control, CAPA, and deviations are completed by the due date.
Identify operational issues associated with the established manufacturing/clinical plans, develop options available for resolving issues, develop key conclusions and recommendations based upon the plans and effectively and proactively communicate options, conclusions, and recommendations to management as needed.
Reduce risk through effective risk mitigation programs that focus on appropriate second source strategies, increasing capacities of our contract manufacturers and shortening supply chain cycle times.
Manage headcount and participate in setting the organization’s annual budget and quarterly forecasting processes. Effectively recruit, retain, develop, and lead a team of professionals.
Establish, communicate, and sustain metrics to monitor manufacturing performance and compliance, and report and present in management meetings as appropriate applying Operational Excellence methodologies.
Work directly with all US and EU manufacturing organizations to ensure compliance of local and international GMP/regulation requirements and perform risk assessment to determine criticality.
Develop comprehensive Commercial Manufacturing strategy for both CMOs and Iovance Commercial Manufacturing facility. Represent Iovance as core representative for all Warehousing, Supply chain efforts for the new commercial manufacturing facility.
Establish procedures and policies regarding commercial operations with CDMO.
Minimize variability and align operations, demand planning and sourcing to ensure minimum financial impact and uninterrupted manufacturing operations and cold chain workflow
Work closely with Technical Operations to identify process improvements.
Oversee the communication of business performance against key performance indicators and associated metrics for production plan adherence and other Operational KPIs. Act as a first line resource to manage the interface between CMO functions pertaining to operations and liaise with internal teams to address issues as needed.
Education and Qualifications:
Bachelor’s degree in Life Sciences, Engineering or related business…