Drug Product Technician - Eurofins CDMO Alphora, Inc.

The Drug Product Technician position in Drug Product Operations will be responsible for a variety of Drug Product specific activities related to GMP clinical manufacturing operations including but not limited to, GMP production of oral drug products, compression and powder handling equipment operation and compliance with GMP systems within the Drug Product Operations department.  The Drug Product Technician will be hands on and execute all aspects of GMP drug product manufacturing of oral dosage technologies for Phase I and II clinical trials. Secondary responsibilities may include ordering of Drug Product supplies and warehouse related operations for Drug Product such as material sampling, secondary or clinical packaging and cycle count support. In addition to the primary responsibilities within Drug Product Operations, the Drug Product Technician may also provide API plant operational support as needed.

DUTIES AND RESPONSIBILITIES:

• Operate Drug Product specific automated equipment technologies such as rotary tableting, wet and dry granulation, blending of powders, milling, spray drying, encapsulation, and coating.
• Execute all aspects of GMP oral drug product manufacturing including but not limited to sampling, compounding, process technologies, and packaging.
• Support Drug Product warehouse operations including material sampling, production preparation, secondary packaging and cycle count support.
• Revise or draft SOP’s, protocols, and batch records as necessary specific to Drug Product Operations.
• Maintain the GMP status of the Drug Product manufacturing facility including, equipment and facility cleaning, environmental monitoring and daily system verifications.
• Support Drug Product engineering personnel with the on-boarding, calibration, maintenance and operation of a wide variety of manufacturing equipment such as tablet presses, fluid bed dyers/coaters, blenders, spray dyer, granulators, etc.
• Provide API plant operations support as necessary.
• Comply with cGMP’s in the execution of duties and responsibilities in Drug Product operations.