Director Bioanalysis and Biologics Analytical Method Development

Location
Exton, PA
Posted
Dec 21, 2020
Ref
DBBA
Required Education
Masters Degree/MBA
Position Type
Full time

Immunome 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, Bioanalysis and Biologics Analytical Method Development, will oversee the management of bioanalysis of our preclinical and clinical programs. This position reports to the Vice President, Product Development and will be responsible for developing strategy, identifying CROs, and executing all aspects of PK/PD and ADA/NAb method development, sample testing, and associated documentations. This position will also be responsible for the establishment of a Biologics Analytical Method Development (BAMD) team and supporting all related Analytical method development and testing activities of monoclonal antibodies (in-house and outsourcing).

Specific Responsibilities and Duties:

  • Clearly define and successfully execute program-specific strategies in Bioanalysis and BAMD.
  • Manage Bioanalysis outsourcing activities with both academic institutions and CROs on objectives and priority setting to deliver robust and reliable bioanalytical assays, and timely sample testing and final reports.
  • Coordinate the preparation of bioanalytical and analytical sections of regulatory submissions, and address any questions from the regulatory agencies.
  • Provide bioanalytical and analytical input and collaborate across all functional areas, including research, process development, preclinical, clinical development, project management, biostatistics, data management, QA, and regulatory affairs.
  • Responsible for assessing risks and developing mitigation strategy in Bioanalysis and BAMD, and communicating and escalating of any issues to senior leadership.
  • Participate at program meetings with CROs/CDMOs, keep meeting minutes, follow-through on action items, update management and implement management directives.
  • Establish quality standards adhering to GLP, GCLP and GMP regulations.
  • Build team of lab scientists and train them to support critical development activities.  

Required Education, Skills, And Abilities

 

  • Ph.D. with 10+ years relevant experience or M.S./B.S. with 15+ years, in conducting bioanalytical and analytical method development, validation, and sample analysis.
  • Experience leading a scientific group is required.
  • Project management experience preferred
  • Demonstrate technical proficiency, scientific creativity and independent thought, as well as ability to collaborate with others.
  • Strong written and oral communications skills.
  • Excellent time management skills.
  • Ability to recruit and manage a team.