about 1 month ago
Associate Director/Director, CMC Lead - Cell Therapy
In office/Hybrid Schedule in Massachusetts or New Jersey
- Lead and represent the cross-functional CMC team with focus on late-stage programs through global commercial license application and approval
- Define and implement the Integrated CMC Product Development strategy for the programs and drive alignment with functional leaders across CTDO and other key stakeholders
- Work across functions to ensure development and manufacturing activities are delivered in accordance with DPT timelines and executed on time according to plan
- Align CMC team members and sub-teams across geographic locations on content and strategy and create synergy in activities taking place at multiple sites. This includes external/internal manufacturing campaigns, process/analytical development, functional characterization, release testing, tech. transfer, comparability campaigns, stability studies, regulatory filings, and other CMC-related activities.
- Lead the CMC Team to track, compile, review, and ensure timely delivery of documents in support of regulatory filings and responses. Ensure the proper scientific rigor to deliver successful clinical outcomes, meet registration needs.
- Lead the cross-functional joint project team in managing the technology transfer and development/manufacturing/testing/logistics CMC activities at the CDMO/CRO/CMO.
- Work with CMC project managers and functional leads to ensure appropriate resourcing and budget development by strategic assessment of milestones and corresponding resource requirements, while providing periodic review of forecasted expenditures. Regularly communicates cross functionally to assess and confirm appropriate allocation and utilization of resources.
- Provide guidance and mentorship to the functional leads/subject matter experts within the CMC team. Maximize alignment, cooperation, input, decision making, commitment and synergy of CMC team members to ensure their technical contributions meet/exceed program objectives. Builds and motivates teams to become high performing.
- Actively involve and support the initiatives to support CTDO Pipeline and Product Lifecycle Strategy (PPLS) business operations, such as streamline development strategies across early to late stage projects, and establish knowledge management system.
Requirements for Associate Director:
- BS/MS or PhD in a scientific field with ≥10 years of experience in product development
- Demonstrated ability for critical thinking and innovation; highly motivated, willingness to acquire new skills and ability to work under ambiguous environment
- In-depth technical understanding of drug development of gene or cell therapy products (preferred)
- Demonstrated successful track record to work with matrix teams to successfully drive results. Proficiency in strategic planning, cross-functional performance management, people dynamic management, and technical leadership.
- Experienced with CMC Regulatory strategy to drive resolution of health authority questions or requests and the milestones and activities necessary to drive regulatory filing documentation.
- Proven leadership experience and savvy influence skills with the desire and ability to work in a fast-paced, collaborative environment. Strong collaboration and team-building, communication, and organizational skills required.
- Excellent written and verbal communication skills