Manufacturing Associate I / II / III (DP) - Packaging

Description

Company Overview

Creating a Healthier World through Accessible Biologics:

Kashiv BioSciences LLC is a fully integrated biopharmaceutical company. Kashiv BioSciences, LLC in the United States, and its subsidiary, Kashiv BioSciences Private Limited in India (together “Kashiv BioSciences”), operate together with robust infrastructure and highly skilled teams that provide global R&D, clinical, manufacturing, regulatory, and IP capabilities. We believe our people, partners, and shared purpose fuel our work to advance patient care and access to important medicines.

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. Must comply with Kashiv BioSciences policies, procedures (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirements.

Essential Duties & Responsibilities

• To take Line Inspection/Line clearance of the Packaging area.
• To operate the syringe labeling machine, label counting, blister packaging, Autoinjector Assembly and labeling machine, check weigher, Semi-Automatic cartonator machine, serialization, aggregation, and tamper-evident sealing Machines by following respective SOP.
• To visually inspect labeled syringes, labeled autoinjector devices, 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 there are no missing components.
• To pack 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 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 of soiled / expired, rejected syringes and materials from the area.
• To ensure 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.

Requirements

Position Requirements and Qualifications:

Minimum Qualifications:

Education and Experience:

• Associate college degree or higher in Biology, Chemistry, Biotechnology, Pharmacy, or related preferred
• Or an equivalent of 1 – 4 years (for Associate I and II) and 4 – 6 years (for Associate III) of industry experience required.
• Operation of packaging machines (Labeling, Autoinjector, blister packing, serialization, aggregation, etc.) is preferred.

Preferred Qualifications: 

Knowledge, Skills, Abilities:

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.

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS: