Head of Analytical Development
Cambridge, MA, USA
Posted on Thursday, November 9, 2023
At eGenesis, we aspire to deliver safe and effective human transplantable cells, tissue and organs utilizing the latest advancements in genome editing.
eGenesis is seeking a Head of Analytical Development to provide tactical and strategic leadership to eGenesis’s Analytical Development activities. In this position you will bring strong drug development experience and the ability to build and deploy tools and best practices to ensure the successful execution of assay development, method qualification, data analysis and validation and method transfer. In this role, you will lead a team of scientists and work closely with Quality Control, Regulatory, and Technical Operations.
- Lead and set the strategy for evaluating and implementing new technologies within the Analytical Development department, with a particular emphasis on state-of-the-art DNA and RNA methodologies
- Communicate with development SME and lead assist in method remediation/trouble shooting
- Perform analytical characterization of human transgenes as needed
- Authorize electronic notebook, SOPs and study reports
- Develop new techniques as needed to expand the analytical capacity
- Develop analytical methods that are accurate, precise, specific, and robust
- Author method validation protocols
- Execute method validation and prepare the necessary reports
- Review analytical testing records of raw materials, stability, and product for accuracy and adherence to test methods
- PhD with 12 years of experience or MS in immunology or related degree with 14+ years of relevant experience in biotechnology
- Experience in immunology analytical methods
- Demonstrated effective leadership skills, has an easily recognized executive presence, and is a proven relationship builder who is effective via influence
- Ability to operate effectively within an entrepreneurial and science-driven company environment; self-motivated, assertive, able to inspire others, driven and hands-on with unquestionable integrity and the highest ethical standards.
- Strong understanding of overall drug development strategies, spanning across all critical product development disciplines (nonclinical, clinical, CMC, RA/QA, commercial strategy and development)
- Strong understanding of GXPs and other applicable compliance requirements