Fill/Finish Associate (Internal Fill/Finish MFG)

Role Summary

Fill/Finish Associate (Internal Fill/Finish MFG) responsible for production and support of drug product manufacturing, including formulation, filling, assembly, labeling, and cartoning/packing for parenteral biological products. Works individually and in a team to maintain equipment and processes, developing proficiency in increasingly complex procedures.

Responsibilities

• Produces life-saving therapeutics for various indications from a dynamic internal pipeline
• Works with a team accountable for production activities from formulation to packaging of final drug product
• Operates highly automated equipment to fill drug product into vials or syringes within isolators or aseptic environments
• Assembles filled drug product into syringes and autoinjectors
• Operates packaging lines to place assembled and labeled drug product into packaging configurations for distribution
• Monitors production line for proper operation through process controls (pneumatics, robotics, manual and PLC feedback)
• Cleans, handles, and installs interchangeable parts for systems and equipment
• Collaborates to create and maintain operating procedures 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 where required
• Performs environmental sampling using various methods where applicable
• Records GMP data accurately, legibly, and contemporaneously and completes reviews
• Maintains and documents all training
• Navigates and utilizes electronic systems to support manufacturing operations
• Travel (domestic and international) may be required
• Ensures compliance with procedures and escalates non-conformities during operations
• Performs reconciliation of product and controlled materials where applicable

Qualifications

• Required for the role: GED/High School diploma and relevant prior work experience
• Ability to perform basic algebra and geometry
• Reading/writing skills
• Must be able to stand for extended periods and lift/push/pull at least 50 lbs
• Knowledge of cGMP and FDA-regulated manufacturing environment; familiarity with cGMP filling, assembly or packaging processes preferred
• Keen attention to detail and demonstrated from previous work experiences
• Preferred experience with aseptic technique and operating filling equipment or with assembly/packaging of parenteral products in vials, syringes, and cartridges
• 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
• Values and acts with integrity

Skills

• Process monitoring and control
• Aseptic technique
• Equipment operation and maintenance
• Documentation and GMP compliance
• Electronic systems proficiency

Education

• GED or High School diploma

Additional Requirements

• Physical requirements for up to 10 hours per shift, including bending, climbing, kneeling, reaching, standing, and lifting/pushing/pulling up to 50 lbs
• Full cleanroom gowning attire and ability to remove jewelry, makeup, and nail adornments in cleanroom environments