Job Details
Summary
This position will be responsible for managing Cartesian's mRNA manufacturing operations across all clinical programs. This position will play a critical role in ensuring the supply of mRNA that meets quality requirements for use in manufacturing Cartesian's mRNA cell therapy programs at multiple stages of clinical development.
Principal Duties/Responsibilities:
- Oversee and manage mRNA production activities for all clinical programs
- Lead an integrated process development, analytical development, and manufacturing team across upstream and downstream functions for mRNA production
- With Cartesian's technical subject matter experts, define and execute development plans that will establish suitable manufacturing processes and control strategies for mRNA
- Partner with the program leader to shape program strategy and execution plan, including development of project timelines, deliverables, and budgets.
- Manage execution schedules of internal and/or external teams to ensure program timelines and deliverables are satisfied within budget
- Contribute to regulatory filings through authorship of technical reports
- Collaborate with functional leads to define program strategy, develop opportunities for innovation, and proactively identify and escalate gaps and challenges
- Develop presentations to summarize progress for the team and for Cartesian's senior leadership.
- Tracking activities against program timelines and budget.
- Administering the day-to-day activities, including, facilitating cross-functional team meetings, leading discussions to drive decision-making, preparing agenda and meeting minutes, and defining and resolving action items.
- Working with the Finance group to implement and track the program budget.
- Contributing to Program Management initiatives to support the development and scaling of capabilities, tools, and processes.
Qualifications:
- Ph.D. in Chemical/Biomedical Engineering, Biochemistry, or a related discipline with 8+ years of relevant industrial experience, M.S. with 10+ years, or B.S with 12+ years
- Strong technical experience in mRNA manufacturing and/or analytics
- Experience executing program development activities as part of a successful IND-enabling and/or clinical program
- Demonstrated ability to hire and develop top scientists/associates
- Strategic thinker with an innovative mindset
- Excellent interpersonal and communication skills (both verbal and written)
- Proven track record of successful project management experience in drug development across multiple phases (pre-clinical and clinical Phase 1-3).
- Prior experience managing or working within cross-functional project teams with timeline management and budgetary responsibility.
- Strong knowledge of project management tools and software (e.g., Asana, MS Project, and timeline visualization software).
- Must be adept at working in a fluid environment and foster a strong collaborative spirit internally and externally.
- Strong personal skills to influence without authority, motivate others and manage conflict.
- Strong written and oral communication skills as well as demonstrated organizational aptitude.
- Preferred: Project/program management training.
- Preferred: Ph.D. or PharmD
Work Environment:
The position requires hands-on work setting up and operating equipment in R&D and manufacturing environments. An employee in this position works in an environment in which safety, environmental and health concerns may demand constant attention. Strict adherence to Cartesian's policies, rules and regulations is required. While performing the duties of this job, the employee handles hazardous chemicals in the laboratory. The employee will be required to wear all appropriate safety equipment including but not limited to eye protection, gloves, shoes, and lab coat. Position may require extended periods of standing.