Fill/Finish Associate (Internal Fill/Finish MFG)

Role Summary

Fill/Finish Associate (Internal Fill/Finish MFG) performing 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.

Responsibilities

• 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
• 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

Qualifications

• 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
• Keen attention to detail
• 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
• Basic understanding of Microsoft Office Suite
• Strong interpersonal, cross-cultural communication, negotiation and high emotional IQ
• Confidence, problem-solving, ingenuity, creativity and resourcefulness
• Ability to understand instructions and work toward established goals
• Ability to listen to team members and stakeholders and support a positive team environment
• Strong and effective communication with peers and management
• Integrity

Education

• GED/High School diploma required
• Previous work experience

Additional Requirements

• Physical requirements for the entirety of shift (up to 10 hours): bending, climbing, crawling, kneeling, reaching, overhead reaching, sitting, squatting, walking, standing, driving, hand manipulation and ability to lift/push/pull up to 50lbs
• Full cleanroom attire and gowning requirements; ability to remove jewelry, makeup and nail adornments when wearing cleanroom attire
• Travel (domestic and international) may be required