Cord Blood Registry (CBR®) Overview:
Cord Blood Registry is a wholly owned subsidiary of AMAG Pharmaceuticals, Inc. AMAG is a biopharmaceutical company focused on bringing therapeutics to market that provide clear benefits and help improve people’s lives. Our products support the care of patients and families facing complex and potentially serious conditions such as high-risk pregnancies, iron deficiency anemia and cancer. Through CBR®, we also help families to preserve newborn stem cells, which are used today in transplant medicine for certain cancers and blood, immune and metabolic disorders. These stem cells also have the potential to play a valuable role in the ongoing development of regenerative medicine. Across our therapeutic areas, we work closely with the medical and patient communities we serve, always seeking to better understand their experiences and needs. These collaborations inform and inspire our work every day to develop and deliver important therapeutics, conduct clinical research in areas of unmet need, create educational and support programs, and expanding our product portfolio with additional therapeutics that could benefit from our business and clinical expertise.
Responsible for directing activities that support and monitor the quality of CBR client products by overseeing daily operations in the Quality Control and Hematology functional areas. Ensure compliance to corporate policies, AABB and other regulatory and quality organizations and standards, and cGLP best practices.
Duties & Responsibilities:
Essential Duties and Responsibilities include the following; other duties may be assigned:
- Ensure compliance with all applicable regulations, standards, systems, procedures and practices.
- Partner with Medical Director, Quality Assurance and Product Operations leadership to ensure on-going compliance and product quality.
- Work with QC, hematology and product operations stakeholders to establish procedures and execute daily workload and projects.
- Maintain an up-to-date knowledge of applicable federal and state regulations and guidelines.
- Institute and maintain quality control, programs, including but not limited to, product sterility testing, environmental monitoring, long-term stability testing and in-process product quality control testing and monitoring.
- Support Quality Assurance in addressing issues documented within the Quality Management System.
- Ensures proper validation of all new or changed procedures, equipment, and processes that directly impact product quality prior to use in the facility.
- Review and approve applicable validation data and summary reports.
- Oversee the testing of equipment for proper operation.
- Assists in design of experiments for Research and Development projects.
- Provide leadership support for the strategic development of regulatory submissions and quality management policies and practices.
- Participate on CBR’s Quality Change Control Board, CAPA Review Board and Management Review Board..
- Work with CBR’s Medical and Technical Laboratory Director(s) to maintain laboratory proficiency/competency program.
- Report out on product quality metrics no less than quarterly.
- Responsible for the overall direction, coordination, and evaluation of QC and Hematology team members.
- Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws.
- Responsibilities include interviewing, hiring and training team members; planning, assigning, and directing work; appraising performance; addressing complaints and resolving problems.
- Perform job functions in fiscally responsible manner.
- Perform duties associated with being a member of Lab Management team, including ‘Manager on-call’ responsibilities.
- Master’s degree in a life sciences discipline and a minimum of 7 years related laboratory experience
- OR Bachelor’s degree in a life sciences discipline and a minimum of 10 years related laboratory experience
- 5 years of management experience as well as demonstrated leadership and technical experience.
- Previous experience with biological products in an FDA regulated environment.
- Ability to clearly communicate information/ideas/recommendations (verbally and in writing) with technical, administrative and management personnel
- Excellent written and oral communication skills in English language. Ability to read, analyze, and interpret the most complex documents.
- Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.
- Proven ability to mentor, develop, supports, and collaborates with staff.
- Strong educator that is able to convey complex information and ideas easily.
- Pro-active, strategic thinker who is results oriented while taking the long term view.
Special Working Conditions:
- While performing the duties of this Job, the employee is regularly required to sit; use hands to finger, handle, or feel and talk or hear; to stand; walk and reach with hands and arms. The employee must occasionally lift and/or move up to 25 pounds.
- While performing the duties of this Job, the employee is frequently exposed to moving mechanical parts and extreme cold. The employee is occasionally exposed to wet and/or humid conditions; fumes or airborne particles. The noise level in the work environment is usually moderate.