Fill​/Finish Associate; Internal Fill​/Finish MFG

We are currently looking to fill a Fill/Finish Associate. The Fill/Finish Associate performs all duties related to the production and support of drug product manufacturing. Works individually, and as part of a team, to support and perform operations to maintain formulation, filling, assembly, labeling and cartoning/packing equipment for parenteral biological products. Seeks to understand and develops proficiency in processes or procedures of increasing complexity.
As a Fill/Finish Associate, a typical day might include the following:

• Produces life‑saving therapeutics for various indications developed from a dynamic internal pipeline
• Works with a team that is accountable for production activities ranging from formulation of drug product to packaging of final drug product, which may include the following process‑related responsibilities:
• Operates highly automated equipment to fill drug product into vials or syringes within isolators or other aseptic environments
• Assembles filled drug product into syringes and autoinjectors
• Operates state of the art packaging lines to place assembled and labeled drug product into packaging configurations for distribution
• Monitors production line for proper operation through process controls including pneumatics, robotics, manual and PLC feedback loop systems
• Cleans, handles, and installs interchangeable parts for various systems and equipment
• Collaborates to create and maintain operating procedures to perform routine activities that adhere to regulatory expectations
• Ensures working spaces and equipment are clean, safe, and ready for processing activities
• Maintains gowning qualification and adheres to clean room behaviors wherever required
• Performs environmental sampling using various methods where applicable
• Records GMP data that is accurate, legible, attributable, and contemporaneous and completes review on those records
• Maintains and ensures proper documentation of all training
• Navigates and utilizes electronic systems to support manufacturing operations
• Travel (domestic and international) may be required.
• Ensures compliance with applicable procedures while executing activities and escalates any non‑conformities during operations
• Performs reconciliation of product and controlled materials where applicable

This role might be for you if:

• Ability to perform basic algebra and geometry
• Reading/writing skills
• Must be able to stand for extended periods of time and lift, push and pull at least 50lbs.
• Knowledge of cGMP and FDA regulated (preferred) manufacturing environment and familiarity with cGMP filling, assembly or packaging processes preferred.
• Necessary to have keen attention to detail and demonstrate from previous work experiences.
• Preferred experience with aseptic technique and operating filling equipment or with assembly or packaging of parenteral products in vials, syringes and cartridges using both manual and automated equipment preferred.
• Basic understanding of Microsoft Office Suite.
• Demonstrates strong interpersonal, cross‑cultural, communication, negotiation and has a high emotional IQ.
• Exhibits confidence and strong problem‑solving skills and demonstrates ingenuity, creativity and resourcefulness.
• Gains understanding from provided instructions and works towards established goals.
• Understands and listens to team members and stakeholders’ needs while supporting a positive team environment.
• Possess a strong and effective communication style among peers and with management team
• Values and acts with integrity

• Ability to perform physical requirements for entirety of shift (up to 10 hours):
• Some physical requirements can include but not limited to: bending, climbing, crawling, kneeling, reaching, reaching overhead, sitting, squatting, walking, standing,…