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The opportunity
The Manufacturing Associate is responsible for performing critical functions related to the manufacture of biological drug products.  This is a hands-on manufacturing position.  You will work as part of a small team to deliver clinical batches in a fast-paced, highly innovative R&D environment.  You will have the opportunity to work with the latest state-of-the-art filling technology, as well as collaborate with colleagues across the drug development, analytical, engineering, validation, and quality areas.   Sterile drug product manufacture is the closest manufacturing process to the patient, so it is essential that individuals working in this area have the highest level of personal integrity and maturity, as well as a commitment to continuous process improvement.
How you’ll spend your day
RESPONSIBILITIES:
•    Perform final visual inspection of sterile drug products, including vial and syringe formats.
•    Perform raw material weighing and dispensing material to media and buffer formulation group.
•    Perform raw material sampling and manage the sampling process in alignment with the Quality Control unit.
•    Update procedures, work instructions, validation protocols, batch records, rationale documents, risk assessments, engineering studies, and other technical and quality documentation required to manufacture clinical batches and maintain compliance with all regulatory requirements.
•    Perform quality investigations, validation activities, and change controls as needed.
•    Associates will also support the manufacturing team as needed to perform all routine production activities needed for the manufacture biologic medicines, including but not limited to: compounding and dilution of bulk biological drug substance, media, and buffers; operation of the filling line and isolator systems; isolator glove interventions during operations using aseptic technique; filter integrity testing; preparation of components and supplies; GMP documentation (batch records, logbooks); and cleaning of critical process equipment.