Position Summary

The Drug Product Manufacturing Associate I / II / III, is a regular employee in a full-time non-exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee will be responsible for the manufacturing of Biotechnology products for clinical and commercial human use. Employee employs aseptic techniques while working in controlled and classified environments, some of which require complete aseptic gowning. Must comply with Kashiv BioSciences policies, procedures (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement.

Essential Duties & Responsibilities

• To take Line Inspection/Line clearance of the Packaging area.
• To operate syringe labeling machine, label counting, blister packaging, check weigher, serialization, aggregation, and temper evident sealing Machines by following respective SOP.
• To visually inspect labeled syringes, blister packs, printed cartons, or shippers for any defects.
• Responsible for submission of samples.
• To participate in investigations if needed. 
• To pack syringes with other necessary components manually in cartons.
• To check the weight of cartons to ensure no missing components.
• To packed good cartons into the shipper and do palletization.
• To submit documents and material requests to start packaging operations to the respective department.
• To verify all drug product syringes before starting of packaging activity.
• To electronically record all the process steps (If required).
• To complete logbooks, Batch Records, and other cGMP documentation accurately and in a timely manner.
• To remove and dispose soiled / expired, rejected syringes, materials from the area.
• To assure that the packaging rooms and surrounding areas are maintained within the required conditions for clean room manufacturing.
• To report all nonconformance or events that arise during the shift to the Supervisor.
• To comply with all safety, cGMP and Company policies, practices, and procedures.
• To perform other functions (Manufacturing, Visual inspection) as required or assigned.
• To comply with all company policies and standards.

Position Requirements and Qualifications

Education:

· Associate degree or higher college in Biology, Chemistry, Biotechnology, Pharmacy or related preferred

· Or an equivalent of 1 – 2 years (for associate 1 and 2) and 3 – 4 years (For associate 3) of industry experience required.

· Operation of packaging machines (Labeling, blister packing, serialization, aggregation etc.) is preferred.

Special Skills:

Language:

· Basic verbal and written communication skills in English with the ability to understand technical information, procedures, batch records, and other documents in English.

· Excellent interpersonal skills.

Reasoning Skills:

· The candidate should have the ability to operate complex systems and equipment in accordance with current GMPs, SOPs, and safety guidelines under minimum supervision.

· Basic skills for identifying problems and troubleshooting of the equipment and manufacturing processes.

· Ability to work independently, within SOP, prescribed guidelines, or as a team member and the demonstrated ability to follow detailed directions.

Computer and/or Technical Skills:

· Skills for working with Computer systems, such as: POMS, LIMS, SAP, NetSuite etc.

· Operation and understanding of word processing, spreadsheets, and data management

· Knowledge of GMP and safety requirements.

· Knowledge of biotechnology operations such as, Aseptic Filtration Systems, Aseptic Sampling, Filter Integrity Testing, stirrer plate, floor scale, peristaltic pump, Weigh Scales, etc.

Work Environment & Physical Demands:

General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines. Some travel may be involved.

Supervisory Responsibility, if any: No

This position description is not a complete list of all responsibilities, duties or skill required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.