Fill/Finish Associate III

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

Shift Requirements: Physical

• 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, driving, hand manipulation and ability to lift/push/pull up to 50lbs

Gowning and Environment

• Full cleanroom attire (Examples may include: including laundered undergarments, gown, facemask, hairnet, safety glasses, safety shoes and booties, latex gloves and the use of sanitizing agents during gowning process including IPA)

• Ability to remove jewelry, make-up and nail adornments when wearing cleanroom attire

To be considered for the Fill/Finish Associate you must have a GED/High School diploma and previous work experience.

Level is figured out based on qualifications relevan