CBM

Full Time EE - Onsite

Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.

CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.

CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.

Summary

This position will contribute to end-to-end preparation of all samples needed for testing to support cell and gene therapy manufacturing, quality control, and external clients. The Sample Coordinator is a member of the sample management team. This team is responsible for the processes involving sample receipt, sample tracking, sample inventory, sample disposal and sample logistics. This includes communicating with multiple departments within Center for Breakthrough Medicines and potentially external clients. 

Responsibilities

• Ensure all incoming sample shipments are intact and record contents of shipments in Sample Control Logbook

• Maintain sample integrity through logging, labeling and proper storage of samples

• Initiate Sample Chain of Custody and certify all appropriate documentation is procured prior to release of samples to the Labs

• Communicate with required parties missing information or other critical sample issues that need to be resolved

• Assist with dispersing received samples to the correct testing departments

• Manage updated inventory of samples in Sample Control Logbook

• Maintain up to date training records on all procedures and protocols applicable to work duties

• Adhere to all departmental SOPs, policies, safety procedures and protocols

• Communicate discrepancies to appropriate personnel and assist with problem solving

• Introduce and develop improvement ideas for the group

• Understand and comply with GMP standards, EHS policies and regulations and ensure workspace and equipment is cleaned and maintained

Qualifications

• High school diploma or equivalent. College Degree preferred

• 3 + years of relevant experience

• Process-oriented and analytical mind-set required

• Exposure to or understanding of cGMP, ISO regulated environment is desirable

• Excellent attention to detail with strong documentation and technical writing skills

• Must be able to thrive in a fast-paced, startup environment with tight deadlines

• Familiarity with Microsoft Office including Word and Excel

• Understanding of Laboratory Information Management Systems (LIMS) preferred