What are the responsibilities and job description for the Associate Director/Director, CMC Program Management position at Stealth Mode Biotechnology Company?
About Us:
We are a startup biotechnology company dedicated to the development of novel cell therapies to cure cancers. The company was founded on pioneering work carried out in the laboratories of Dr. Carl June and Dr. Andy Minn (University of Pennsylvania), Dr. Kole Roybal (UCSF), and Dr. Christopher Garcia (Stanford University). We are using viral vectors, universal targets, and novel cytokine biology to enhance CAR T activity in solid tumors. Our therapeutic approach has potential to be used across multiple tumor types, enabling us to treat significant numbers of cancer patients.
Based in Philadelphia and San Francisco, we are backed with significant investment by prestigious investors including ARCH Ventures and the Parker Institute for Cancer Immunotherapy. At our company, you would become one of our early team members where you would help to define and hone our science, be a vital part of building our culture, and contribute to the company’s future success. Here, you would collaborate with a top-notch team who care about patients and each other. We have an ownership mindset and are innovative, curious, driven, and resilient. We take time to build relationships because trust unlocks our ability to debate, share, forgive, and grow together - ultimately in service of our vision to create a universal cure for cancerous solid tumors and improve outcomes for patients.
The Role:
The Associate Director/Director, CMC Program Management is a highly impactful and dynamic role that will drive planning, oversight, and execution of CMC deliverables and activities for Dispatch programs. This individual will also play a key role in managing and ensuring accountability of key external CMC partners and Contract Manufacturing Organizations (CMOs). The successful candidate will be an effective communicator, be able to influence cross-functional team members, and ensure coordination with overall program strategy and Asset Team objectives.
Key Responsibilities:
Project Management & Cross-functional Collaboration
- In alignment with overall program objectives and strategy, develop and manage detailed project plans and timelines focused on CMC activities, including but not limited to process development, analytical development, manufacturing, operations, quality, and Regulatory CMC.
- Manage cross-functional teams and meetings, ensuring accurate and timely communication of project activities (minutes, action items) to key CMC stakeholders and broader Dispatch Asset Teams.
- Proactively track project progress and identify key milestones, risks, bottlenecks, and mitigations; support scenario planning and identification of acceleration opportunities.
- Collaborate with Regulatory Affairs to ensure CMC team deliverables for health authority interactions and filings are completed in a timely manner (pre-IND/HA meetings, INDs, CTAs, etc.).
- Hold functional teams accountable for committed objectives and timelines.
- Ensure teams adhere to project budgets and resource allocation.
- As necessary, provide broader development-focused program management support to Dispatch Asset Teams.
Vendor and Partner Management
- Serve as key point of contact and oversee management of current and future external contract manufacturing organizations (CMOs) and CMC partners.
- Oversee coordination, execution, and maintenance of CDAs and other related contractual agreements as needed with CMC vendors & partners.
- Provide overall project management support for appropriate joint partner & CMO workstreams.
Required Experience & Skills:
- Bachelor’s and/or Master’s Degree in a scientific discipline
- Minimum of 8 years of experience in the biopharma industry, with a focus on managing and/or leading projects from a technical development perspective
- Strong understanding of CMC development, including GMP manufacturing, process development, analytical development, quality, operations, and Regulatory CMC
- Demonstrated ability to work with urgency and manage multiple complex projects in a lean and fast-paced environment
- Proficiency with project management tools and software (MS Project, AirTable, Smartsheets, etc.)
- Exceptional organizational, communication, and problem-solving skills
Preferred Experience & Skills:
- PMP certification or equivalent is preferred
- Experience working with and managing external partners (CMOs, CROs) is strongly preferred
- Previous experience with cell therapies and viral delivery platforms is highly valued
- Prior experience in development-stage or startup biotechnology companies
- Core understanding of early drug development and operating as part of a matrix team
- Experience working in oncology, rare diseases or other therapeutic areas of high unmet need
Working Here:
- We offer a highly competitive compensation package with meaningful ownership
- Excellent coverage for medical, vision, dental
- 401(k) with generous match
- Life insurance
- Premium PTO policy
- Additional substantial benefits
We are an equal opportunity employer.
We are committed to inclusion and diversity, and we do not discriminate on the basis of race, gender, religion, gender, sexual orientation, age, color, marital status, veteran status, disability status, national origin, or any characteristic protected under applicable law.