Jennifer Dashnau Ph D MBA

SVP, Technical Operations at Context Therapeutics, overseeing end‑to‑end CMC strategy and operational execution across a portfolio of bispecific T‑cell engagers. I lead process and analytical development, external manufacturing, supply chain, and quality to enable rapid, compliant, and phase‑appropriate advancement of our programs. My work focuses on building a scalable Tech Ops organization, strengthening CDMO partnerships, and ensuring robust readiness for late‑stage development, pivotal trials, and commercialization. I’m passionate about translating innovative science into manufacturable, high‑quality therapies that meet patient need.

• Provided strategic leadership for the Analytical Research & Development organization, including development of the long-range operating plan and budget. • Developed sophisticated financial planning model, resulting in exceptional budget control with actuals maintained within +/-5% of budget annually. • Served as Integration Lead for the acquisition of Clade Therapeutics, demonstrating strong leadership in developing and executing the Day One, First 100 Days, and long term plans for stabilizing and transforming the organization.

• Built high-performing analytical development and quality control organizations from the ground up, establishing analytical strategy and overseeing internal and external testing. • Established a novel CMC regulatory strategy for genetically-engineered, iPSC-derived cell therapies, working across industry and regulators to shape evolving regulatory expectations and guidance documents. • Managed Module 3 authorship for the company's first IND (CNTY-101), resulting in FDA acceptance with no major CMC-related comments.

• Spearheaded a transformative initiative to refresh the long-term manufacturing strategy for the Merck Manufacturing Division, impacting 90 global manufacturing sites. • Led collaboration between executive leadership and external consultants to survey Industry 4.0 trends, identify strategic goals and objectives, and develop key performance indicators. • Developed a comprehensive communication plan, incorporating change management principles, for rollout to the Top 200 Vice Presidents. • Implemented a Hoshin Kanri framework, establishing a "catchball" process to foster top-down and bottom-up alignment of annual objectives with the overarching strategy.

• Pioneered an accelerated development playbook as part of the Late-Stage Development Team framework, reducing the late-stage biologics development timeline to less than 15 months. • Led strategic development and growth of three internal analytical laboratories, overseeing 30 scientists and the design of two new laboratories to address the escalating demand for KEYTRUDA and ZINPLAVA testing. • Implemented a modular resource model leveraging Lean Six Sigma methodology, achieving a 5-fold increase in laboratory throughput and 50% reduction in turnaround time.

• Championed a multi-department team of over 60 contributors from analytical development and quality control to mitigate risks and enhance robustness of legacy analytical methods for the hexavalent vaccine joint-venture with Sanofi Pasteur (VAXELIS®). • Devised a risk-based approach to systematically address and remediate analytical validation gaps, completing remediation of 80 assay validation packages within 11 months and ensuring compliance.

• Led a team of engineers, overseeing development, process scale up, technology transfer, validation, and continuous process verification for late-stage and commercial vaccines, including GARDASIL® and GARDASIL®9. • Successfully developed, transferred, and validated the optimized downstream purification process for GARDASIL®, resulting in a 50% yield improvement and $250M cost savings. • Led the development, transfer, and validation of the GARDASIL®9 fermentation and downstream purification process for five new serotypes across multiple commercial-scale facilities (3000L and 6000L), to support global regulatory approval of the second-generation human papillomavirus vaccine. • Developed the framework for evaluating process and facility comparability, championing multiple comparability assessments and regulatory authorship for post-approval changes.

Performed GMP quality control testing and evaluation of Vitros Chemistry Products (thin-film technology) on Vitros 750/950 Chemistry Systems

Redesigned training materials, developed laboratory coursework, managed teaching assistants, and instructed undergraduate-level biology and biotechnology laboratory courses including Introduction to Developmental Biology Laboratory, Genetics Laboratory, General Biology Laboratory.

Provided program and account management support for department focused on improving information technology accessibility internationally in underserved populations – specifically for deaf and hearing-impaired students in the secondary education setting.