|Title:||Director, Manufacturing Project Management|
|Department:||Manufacturing Sciences and Technology|
Director, Manufacturing Project Management
About SwanBio Therapeutics
SwanBio is a privately held, newly established biotechnology company focused on the discovery and development of innovative gene therapy products for the treatment of central nervous system (CNS) disorders and diseases. SwanBio has a deeply experienced leadership team and is building an open, innovative culture that trusts its people, processes and science to deliver scientific, clinical and business success. Our lead investor, Syncona, is a premier health care company with a proven track record of successful long-term investment strategies in Gene and Cell Culture companies. Our goal is to become a world-leader in treating neurodegenerative diseases. With locations in Philadelphia and Boston, the SwanBio Team is building a strong pipeline of gene therapy development programs with a directed focus on critical unmet medical needs for CNS diseases.
About the Opportunity
SwanBio Therapeutics seeks a strong and highly-skilled project manager to help build out the company’s integrated strategic and operational plans for the manufacture of its lead clinical program and the structuring and establishment of a manufacturing platform-based supply chain for future clinical and commercial programs. This person will support scientific program leaders and other functional leaders in project and portfolio scenario-building and planning. This position provides a critical role within the company with responsibility to track key manufacturing milestones and dependencies. This position will have a dual reporting relationship, reporting to both the Global Program Management Vice President and the Chief Technology and Manufacturing Officer. He/She will be an integral supporting member of the CMC leadership team responsible for building a center of excellence with deep expertise in gene therapy (e.g., AAV-based therapeutic dose forms) manufacturing processing and, more generally, biologics processing to aid in the identification of scientific and technological opportunities to improve upon product quality, product cost, process robustness, process productivity, and quality compliance. It is essential that the incumbent is a strong team member with the ability to create platforms that capture strategy and operational dependencies.
- Manage projects of varying complexity and/or multiple projects independently within the CMC department;
- Develop and coordinate resource planning across functions to ensure adequate resourcing;
- Develop and maintain high-level and detailed manufacturing project / program timelines ensuring consistency with current input from functional leads and overall program leadership;
- Work closely with Global Program Management organization to ensure integration of manufacturing timeline information with overall program planning;
- Ensure that near-term and longer-term functional timelines remain aligned with longer-term global project timelines;
- Track all aspects of the various timeline components and raise potential problems / conflicts / issues with program leadership participating in the problem-solving and resolution of potential on-going timeline challenges;
- Lead manufacturing team meetings with focus on overall timelines, including setting agendas and issuing minutes from key meetings; interface effectively with CDMOs/CROs and external project team members, maintaining regular communication to ensure timely updates on current project status, issues, contingencies, and milestones.
- Identify, communicate and manage risks registers in relation to manufacturing activities;
- Prepare monthly manufacturing project update reports and timeline revisions, as required;
- Provide important role of ensuring that decisions made at the program level are assessed as to their impact on the current manufacturing timeline plan, budget and resource availability;
- Provide important role as part of the CMC Team of ensuring financial oversight of ongoing program(s) including working closely with Finance in budget reviews, accruals and forecasts; will also participate in identifying and negotiating change orders, requesting/tracking purchase orders, approve completion of work components of invoices, and participate in / conduct financial review meetings with vendors;
- As part of the manufacturing team and in alignment with the Global Program Management, recommend and implement best practices (e.g., resource planning, risk management);
- Will be leader of a departmental team focused on establishing and supporting a highly functioning project management tracking and performance metric system;
- Present updates to senior leadership, as well as colleagues, on a regular basis within routine company meetings.
- Bachelor’s degree in healthcare related area or business;
- Minimum of 8 years of pharmaceutical experience (preferably, in both small and larger companies);
- Requires 3 - 5 years of drug development project management experience working with third party CMOs;
- MS/ MBA or PhD preferred;
- PMP certification preferred;
- Excellent project management and communication skills with the ability to operate both tactically and strategically;
- Strong conflict resolution and consensus building skills with a motivation to deliver positive team-based results;
- Proven leadership skills, maturity, and emotional intelligence necessary to the successful influencing of others without authority over their work.
About the Benefits The successful Candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs including bonus and stock option plans. Additionally, SwanBio Therapeutics offers all team members a comprehensive benefits program including: medical, dental, vision care, 401(k), paid vacation and Holiday time.
SwanBio Therapeutics is an equal opportunity employer.