Our large pharmaceutical client in Spring House, PA is seeking an Associate Scientist to join their growing Cell Therapy API (Active Pharmaceutical Industry) Development organization and support blood sample management and testing activities. This individual will be completing apheresis formulation, cryopreservation of samples, managing and tracking sample inventory, maintaining and ensuring accuracy across databases as well as owning sample delivery and coordination across internal teams. Training is provided for this role and this team provides a lot of opportunity for growth! Other responsibilities include:
Completing formulation of apheresis material and working with multiple species blood samples to support the pipeline portfolio and explore novel and innovative approaches to safety assessment in drug development.
Sample coordination which includes:
-Managing request forms to determine material needed (new formulations or reserved material)
-Managing material hand off
-Forecasting, coordinating, and submitting samples of fresh apheresis material to other internal teams for requested testing
-Keeping records of orders, COA, etc.
Executing cryopreservation for samples and storing material
Maintaining internal databases and ensuring correct sample information is updated and accurate which includes authoring eLNs of formulation and updating Sharepoint with inventory and DA analysis
Tracking and coordinating inventory which includes:
-Getting quotations for new leukapheresis material from collection agencies based on forecasts
-Placing orders through procurement group to ensure funds are used from appropriate projects for collections
-Tracking and following up with vendors
Interpreting and communicating data with an appropriate level of independence
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-2+ years of relevant lab-based experience including cell cryopreservation
-Previous experience with mammalian cell culture and aseptic techniques
-Familiar with formulation of apheresis material
-Strong organizational skills and experience tracking & managing sample inventory, maintaining and ensuring accuracy across databases as well as managing sample delivery and coordination across internal teams.
-Cell therapy process development experience (ideally CAR T)
-Experience using controlled rate freezer (CRF)
-Knowledge of immunology or bioprocess engineering or related scientific methodologies
Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.