Director – Immune Evasion
Location: Germantown, MD
Role and responsibilities:
Seraxis is a rapidly growing regenerative medicine company focused primarily on a replacement cell therapy for insulin-dependent diabetes. Seraxis is working to launch multiple clinical trials in 2023.
We are seeking an exceptional and highly motivated Director of Immune Evasion to join our dynamic team. In the field of cell replacement therapy, two strategies are employed to avoid immune suppression in the host of an allogeneic transplant: a physical device that prohibits cellular contact between the graft and the host, and; genetically modified cell lines that are less capable of stimulating the host immune system. Seraxis has developed both of these strategies, the SeraGraft Device and a hypoimmunogenic version of its proprietary cell line. The duties of this position focus on characterization and testing of these two technologies to support clinical applications.
The position requires demonstrated ability to work in a fast-paced, hands-on, and collaborative environment. Strong commitment to quality, compliance and scientific excellence is necessary. The selected candidate will benefit from a unique opportunity to become a major contributor to the success of a well-positioned and growth-oriented cell replacement therapy company.
The job responsibilities include:
- Oversee and perform characterization and testing of SeraGraft to meet international regulatory standards for clinical testing
- Familiarity with ISO10993-1 and biological evaluation of medical devices is required
- Oversee and perform characterization and testing of hypoimmunogenic cell line to meet international regulatory standards for clinical testing
- Oversee collaborations related to immune evasion strategies
- Develop and support the implementation of processes and SOPs related to SeraGraft manufacture and use
- Participate in the design and implementation of biocompatibility and safety testing of SeraGraft
- Work within a GLP/GMP regulated environment
Qualifications and Skills:
- Ph.D. in Biology, Immunology, Biochemistry or related discipline with 5+ years of experience related to immunology, anti-immunity, graft rejection, or biocompatible device development.
- Demonstrated knowledge of cGMP practices, ICH/ FDA guidance documents and quality system.
- In-depth scientific knowledge and technical proficiency.
- Excellent oral and written communication skills.
- Demonstrated ability to work in a cross-functional team environment and to design experiments and research strategy.
Job type: Full time
Salary range: Competitive. Stock options. 401K
Seraxis is an Equal Opportunity Employer. Please email cover letter and resume to email@example.com.