Job Description: CMC Project Manager (PM) – Sr. Project Manager (Sr. PM)
Reporting to the Vice President of Pharmaceutical Development, this individual will serve as an integral member of technical process development, analytical, and manufacturing teams at Elicio Therapeutics. This person will partner or support the CMC and technical leads to develop and analyze product development scenarios as well as manage complex early and late stage project activities. This cross-functional position requires in-depth understanding of the operations and planning of at least one key area in CMC product development such as: drug substance, drug product, combination product, or analytical development and quality control. Working knowledge of clinical and commercial supply and CMC regulatory is a plus. The project manager will participate in external vendor selection as well as contract and alliance management.
- Develop and manage integrated project plans for one or more products
- Participate in scenario development and strategic planning
- Partner with technical project leaders to run project meetings, communicate progress, coordinate and prioritize activities
- Prepare clear communication documents such as meeting minutes and registers capturing decisions, actions, risks and assumptions
- Facilitate routine project health assessments including risk identification, mitigation development, and communication/escalation to key stakeholders as appropriate
- Facilitate material transfers (domestic and international)
- Assist with supply chain management and forecasting
- Assist project teams with preparation for governance meetings and portfolio reviews
- Mange contracts with external vendors (includes support of scope development, negotiations, progress and invoicing)
- Key contributor to budget development and long-range forecasting
Education & Professional Experience
- Requires a Bachelor’s degree in Science, Engineering or a related field with 5-7 years relevant industry experience in biopharma manufacturing/business; or Master’s Degree in Science, Engineering, Business or a related field with 3-5 years relevant industry experience
- A minimum of 2 years project management experience as either a designated project manager or PM responsibilities as part of a technical role
- Strong written/oral communication skills including meeting management, and presentation development and delivery
- Strong business acumen
- Ability to foster effective relationships and collaboration, motivate others, influence without authority
- Prior experience working with CDMOs
- Working knowledge of both large and small molecule process development and GMP manufacturing
- Informed on current biopharmaceutical industry requirements, news and trends and ability to apply to programs
- Independent, motivated team member with experience in a fast paced environment
Travel: Travel is required (up to 10%)
Physical Requirements: Subject to periods of sitting or standing, vision is required to monitor data. Work is generally performed in an office environment.
About Elicio Therapeutics
Elicio Therapeutics is advancing the Amphiphile technology across immunotherapy platforms to defeat cancers and infectious diseases. By combining expertise in materials science, immunology, and immuno-oncology, Elicio is engineering potent Amphiphile immunotherapies that precisely target and fully engage the lymph nodes, the site in our bodies where the immune response is orchestrated. Elicio is engineering lymph node targeted cell therapy activators, immunomodulators, adjuvants and vaccines for an array of aggressive cancers and infectious diseases. The Amphiphile platform emerged from laboratories of Darrell Irvine, Howard Hughes Investigator and Professor of Biomedical Engineering in the Koch Institute of Integrative Cancer Research at MIT. For more information, please visit https://elicio.com.
About the Amphiphile Platform
The Elicio Amphiphile platform enables precise targeting and delivery of immunogens and cell-therapy activators directly to the lymphatic system, the “brain center” of the immune response, to significantly amplify and enhance the body’s own system of defenses, defeat solid and hematologic cancers, and prevent their recurrence. Once in the lymph nodes, Amphiphile immunotherapies are taken up by antigen presenting cells (APC’s) to orchestrate signaling to natural or engineered immune cells in order to maximize therapeutic immune responses to disease. This strategy has been used to improve the activity of immunostimulatory agents, antigens, adjuvants, and cell-therapies that generate little to no response when used in the conventional forms. By precisely targeting these immunotherapies to the lymph nodes, Amphiphiles can unlock their full potential to generate and amplify anti-tumor immune responses. This substantially enhanced anti-tumor functionality and long-term protective memory may someday unlock the full potential of the immune response to eliminate cancer.