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Sample Management Specialist

2 months ago

Florham Park, United States Celularity Full time
Job DescriptionJob DescriptionDescription:


About Celularity

Celularity Inc., headquartered in Florham Park, N.J., is a biotechnology company leading the next evolution in cellular medicine by developing off-the-shelf placental-derived allogeneic cell therapies for the treatment of cancer and immune and infectious diseases. Celularity is developing a pipeline of off-the-shelf placental-derived allogeneic cell therapy product candidates including T cells engineered with a chimeric antigen receptor ("CAR"), natural killer ("NK") cells, and mesenchymal-like adherent stromal cells ("MLASCs") and exosomes. These therapeutic candidates target indications across cancer, infectious, and degenerative diseases. Celularity believes that by harnessing the placenta’s unique biology and ready availability, it will be able to develop therapeutic solutions that address a significant unmet global need for effective, accessible, and affordable therapeutics.


Summary

The entry level Sample Management Specialist at Celularity plays an important role in ensuring the efficient handling, tracking, and distribution of Quality Control samples with both internal and external laboratories. This position requires meticulous attention to detail, organizational skills, and adherence to regulatory guidelines to maintain sample integrity and confidentiality.


Responsibilities will include, but are not limited to, the following:


Sample Receipt and Logging:

  • Receive incoming samples from various sources, including Manufacturing and Research Development.
  • Accurately log samples into the designated tracking system/database, recording pertinent information such as sample identification, quantity, and storage requirements.
  • Ensure proper labeling and documentation of all received samples to maintain traceability.

Storage Management:

  • Safely store samples in appropriate conditions, adhering to specific temperature and environmental requirements as specified by standard operating procedures (SOPs) or regulatory guidelines.
  • Maintain and manage the Sample Retention room inventory.

Sample Preparation and Distribution:

  • Prepare samples for analysis or distribution to internal and external laboratories according to established protocols and SOPs.
  • Coordinate with laboratory personnel to schedule sample pickups or shipments, ensuring timely delivery and adherence to transportation regulations.
  • Maintain accurate records of sample distribution, including tracking numbers, shipping documents, and recipient information

Quality Assurance and Compliance:

  • Adhere to Good Laboratory Practices (GLP), current Good Manufacturing Practices (CGMP), and other relevant regulatory requirements governing sample management activities.
  • Participate in quality control procedures, such as sample inspections, to ensure sample integrity and compliance with quality standards.
  • Assist in investigations of sample-related deviations, discrepancies, or non-conformances, and implement corrective and preventive actions (CAPAs) as necessary.

Documentation and Reporting:

  • Generate and maintain documentation related to sample management activities, including chain of custody documentation.
  • Receipt and maintain Certificate of Analyses or other similar reports from external laboratories for use by Quality Control.

Communication and Collaboration:

  • Involved in communications with internal departments, external vendors, and laboratory personnel regarding sample-related inquiries, requests, or issues.
  • Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Research and Development, to ensure alignment of sample management processes with organizational goals and regulatory requirements.
Requirements:

Education and Experience

  • Associate’s degree in a scientific discipline, such as biology, chemistry, or pharmacy.
  • Previous experience in sample management or a related field preferred.
  • Knowledge of regulatory requirements governing sample handling and storage (e.g., FDA guidelines, ICH guidelines).
  • Strong organizational skills with the ability to prioritize tasks and manage multiple projects simultaneously.
  • Excellent communication skills, both written and verbal, with the ability to interact effectively with internal and external stakeholders.
  • Attention to detail and commitment to maintaining data accuracy and integrity.
  • Proficiency in computer applications such as Microsoft Office (Word, Excel, Outlook) and database management software.

Working Conditions

  • The incumbent will be working in an office and laboratory environment.
  • Flexible scheduling required.

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job.


This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. There are other duties and responsibilities considered incidental or secondary to this job's overall purpose. Employees/contractors holding this position will be required to perform any other job-related duties as requested by management.


Must be authorized to work directly for Celularity in the U.S.

No agency submittals accepted through this website.

Celularity is an Equal Opportunity Employer


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