Position: Associate Director, CMC Program Management
Reports to: VP, Manufacturing and Operations
Seeking an experienced Associate Director, CMC Program Management, with a strong biologics product development background to support its CMC team in coordinating activities related to development, manufacturing and validation of both early and later stage programs at ContraFect. Roles and responsibilities include:
- Facilitate development and oversee execution of CMC project plans, including but not limited to planning of clinical manufacturing, process characterization and validation activities, analytical method feasibility, qualification and validation, PAI readiness activities.
- Create and manage integrated Gannt charts using Microsoft project software, tracking tasks and percent completion. Work with contract manufacturing and research organizations (CMOs and CROs) ensuring their individual Gannt chart or other type of project plans are routinely updated and integrated into an internal master schedule.
- Lead CMC team in the identification of risks to achieving goals and milestones, ranking of those risks, and development and implementation of mitigation activities where warranted.
- Server as primary contact between ContraFect and Contract Manufacturing Organizations, including oversight of Joint Program Team and Joint Steering Team Meetings.
- Develop and update dashboards on a routine basis that clearly communicate status of CMC team’s goals, issues, risks and mitigation strategy.
- Schedule and coordinate CMC team meetings, agendas and minutes.
- Coordinate development of slide decks as needed for updates to Sr. Management including ability to visualize information (i.e. timing, issues etc…) to enable decision making.
- Work in collaboration with the VP of Program Management and PM support staff to provide CMC updates for government funded contract reporting.
- B.S. degree in scientific field plus at least 7 years of experience in the biotechnology or pharmaceutical industry.
- Minimum of 5 years’ experience in Project or Program Management at a biotechnology or pharmaceutical company with direct involvement in the CMC area.
- PMP certification is required. Microsoft Project, PowerPoint, Excel skills are essential.
- Strong understanding of pharmaceutical product development, including US and EU pharmaceutical regulations.
- Excellent interpersonal and organizational skills, with an ability to build relationships at all levels of the organization, including external vendors and senior management.
- Excellent oral and written communication skills
- Prior experience working with CROs/CDMOs is preferred
- Ability to multi-task, prioritize complex daily workload and work in a virtual environment
- Respect. People matter.
- Patient- Focus. Act with urgency and passion to save lives.
- Leadership. Set high standards, and empower others to do the same.
- Innovation. Challenge the status quo to deliver solutions.
- Collaboration. Work together to achieve our vision.
- Quality. Strive for excellence in all that we do.
- Integrity. Courage to be honest, ethical, and transparent.
Salary: Commensurate with experience.
Please fill out the form below to submit your resume.