Laboratory Medical Director, LifebankUSA and Tissue Products

Celularity Inc., headquartered in Florham Park, N.J., is a clinical-stage biotechnology company leading the next evolution in cellular medicine with the development of off-the-shelf allogeneic cellular therapies derived from the postpartum human placenta. Celularity’s innovative approach harnesses the unique therapeutic potential of cells derived from the postpartum placenta, including CAR-T, genetically-modified and unmodified NK cell, and pluripotent stem cell investigational therapies targeting unmet and underserved clinical needs in cancer, and infectious and degenerative diseases.

Celularity is seeking a dynamic individual to join a motivated team supporting the company’s Manufacturing Operations functions.  The Laboratory Medical Director,  is responsible for the medical oversight, development, implementation and quality of the policies and procedures required for the services and manufacturing of the company’s multiple Human Cells and Tissue-Based Products (HCT/Ps). In conjunction with the Quality group, ensure all policies and procedures in compliance with appropriate federal and state agencies and various accrediting bodies. Will work with the Medical Affairs team in the support of manufactured products as needed.

• Set medical criteria and standards for donor qualification (history, disease testing, etc.). Continually evaluate state and federal requirements, CDC and WHO guidelines and revise criteria as required.
• Medical and technical oversight of all processes related to the acquisition, processing, storage, and release of the company’s HCT/P products processed or distributed for human use (and the various products offered through the LifebankUSA program.
• Review donor records and TTD test results for evidence of risk factors and determine donor eligibility for clinical use of donated materials, as needed. Similar assessments are to be made for donors enrolled in LifebankUSA private banking program.
• Within LifebankUSA banking program, review and edit scripts as necessary for customer service and donor representatives.
• Communicate with donors and/or their physicians when transmission of abnormal lab results or other information is indicated. Track abnormal and/or positive results for trends.
• Educate donors regarding program offering and associated questions.
• Oversee proficiency testing program for LifebankUSA products.
• Review, approve, and edit as necessary all therapeutic and scientific claims in educational and promotional materials per AABB/AATB requirements.
• Manage inventory of donor registry units and correspond with registries and hospitals across the globe to ensure patients in need receive the best-suited blood products available to them. Ensure these products are released at the highest quality and in a timely manner.
• Provide operational and/or medical support as needed at clinical research sites related to the company’s HCT/P products.
• Collaborate with investigators and/or internal departments on the design and review of study-related documents and manuscripts.
• Serve as medical liaison to the medical community for patient advocacy outreach.
• Provide medical and technical leadership with all registrations, accreditations and licensures, including those required by FDA, AABB, AATB, and states.
• Perform compliance duties, including review/revision of SOPs and adherence to regulations and standards. Review and sign off on related quality assurance and quality control records.
• Support Manufacturing Operations as with development activities and process improvement initiatives. Serve in project management capacity as needed.

Minimum Qualifications (Must have)

• Licensed physician.
• Licensure to be held in New Jersey and New York.
• 5+ years’ Medical Laboratory Director experience with 2+ years’ experience in a clinical lab and blood/tissue bank.
• 2+ years’ experience or training in clinical hematology/oncology that includes experience in bone marrow transplantation or two years’ experience in transfusion/laboratory medicine in addition to either one year’s experience in hematopoietic progenitor cell collection or performance or supervision of at least 25 hematopoietic progenitor cell collection procedures.
• Supervision of at least 25 HPC collections and/or transplantation procedures.
• 2+ years’ leadership at organization offering products/services under HCT/P and/or GMP standards.
• Proven track record managing facilities that meet regulatory guidelines with history of successful regulatory audits.
• Strong organizational and time management skills.
• Ability to work well in a team environment.
• Excellent verbal and written communication skills as well as strong focus and attention to detail.

Preferred Qualifications 

• 2+ years’ relevant experience with clinical manufacturing and operation within cGMP environments.
• Understanding of federal regulations for Quality Systems (21CFR820) and GMP manufacturing (21CFR 210,211).
• Demonstrated scientific creativity, technical proficiency, and knowledge of scientific concepts.
• Understanding of clinical cGMP manufacturing operations.
• Knowledge of GxP regulations (cGTP, cGDP, cGMP).
• Experience in a fast-paced, scientific start-up environment.
• Dynamic individual with the ability to communicate and engage others.