Director Biologics CMC
Immunome (www.immunome.com) is a rapidly growing biotechnology company utilizing a proprietary human memory B cell platform to discover and develop first-in-class antibody therapeutics, with a focus on oncology and infectious diseases including COVID-19. We have an ambitious vision and a growing pipeline of novel antibody product candidates to treat solid tumors and infectious diseases using our proprietary antibody discovery engine. To achieve our mission, we seek a highly motivated professional who shares our dedication to patients and our passion for discovery, development, and commercialization of monoclonal antibody therapies.
The Director, Biologics CMC, will oversee the management of our development programs and be reporting to the Vice President, Product Development. This position works with both internal scientific colleagues and external vendors/CROs/CDMOs in Research, Lead Development, Antibody Engineering, Translational Biology, Process Development, CMC, QA, Regulatory and clinical development functions of Organization. This position will be responsible for all aspects of CMC activities, from process development, manufacturing and testing to preparation of CMC documents and IND filings.
Specific Responsibilities and Duties:
- Clearly define and successfully execute program-specific CMC strategies in product development and regulatory filings.
- Manage third party activities related to project planning, deliverables, scheduling, timeline, resourcing, raw material vendors, testing CROs, and development and manufacturing CDMOs.
- Responsible for assessing risks and developing mitigation strategy, and communicating and escalating of any CMC and timeline issues to leadership.
- Participate in meetings with CDMOs, take meeting minutes, follow-through on action items, update management and implement management directives.
- Coordinate the preparation of CMC sections (Module 3 of CTD) of regulatory submissions, and address any questions from the regulatory agencies.
- May require periodic travel to CROs/CDMOs for audits, inspections, meetings or as a person-in-the plant during GMP production.
Required Education, Skills, And Abilities
- Ph.D with 10+ years relevant experience or M.S./B.S. with 15+ years, in conducting Biologics R&D, project management, and CMC activities.
- In-depth knowledge of FDA, EMA and ICH regulations and guidelines.
- Experience in Biologics process and product development, leading the team and working across different functional groups.
- Previous contributions to IND filings preferred.
- Client-side experience working with vendors, CROs, and CDMOs
- Experience in Microsoft Project or other project management tools.
- Strong written and oral communication and collaboration skills
- Experience negotiating with vendors and collaborators.
- Excellent time and project management capabilities and ability to be effective under tight timelines and in a high-growth environment.