Manufacturing Associate I ​/ II (DP) – 2nd Shift - Aseptic Fill

Company Overview

Kashiv Bio Sciences LLC is a fully integrated biopharmaceutical company. Kashiv Bio Sciences, LLC in the United States, and its subsidiary, Kashiv Bio Sciences Private Limited in India (together “Kashiv Bio Sciences”), 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.

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

• To take Line Inspection/Line clearance of ISO6, ISO7, and ISO8 areas.
• To weigh and dispensing of materials
• To operate Part washer, autoclave, filter, and mixing system
• To operate Syringe filler and non-viable particle count.
• To calibrate and verify pH and conductivity meter, weighing scale.
• To standardize and operate peristaltic pump.
• To perform filter integrity test.
• To involve in formulation and Filtration of drug product
• To involve in Aseptic filling activity with good aseptic area behavior.
• To clean ISO5 and ISO6 areas as per SOP.
• To maintain inventory (Disinfectant solution, gowns, goggles, wipes, etc.).
• To verify all raw materials and other consumables.
• Responsible of equipment’s assembly, cleaning, sterilization, and operation.
• To prepare media and buffer solutions.
• Responsible for submission of samples, in-process testing, such as pH, Conductivity, personnel monitoring plates etc.
• To submit documents and material request to start batch manufacturing operation to respective department.
• To electronically record all the process steps (If required).
• To complete Batch Records and other cGMP documentation accurately and in a timely manner.
• To remove and dispose of soiled / expired materials from the manufacturing area.
• To ensure that the manufacturing 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 assist in the transfer of technology from Process Development to cGMP Manufacturing.
• To comply with all safety, cGMP and Company policies, practices, and procedures.
• To perform other functions (Packaging) as required or assigned.
• To comply with all company policies and standards.

• 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) of industry experience required.
• Operation of Autoclave, filling machine, Aseptic techniques, and clean room manufacturing experience is preferred.

• 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.

• 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.

• Skills for working with Computer systems, such as: POMS, LIMS, SAP, Net Suite etc.
• Operation and understanding of word processing, spreadsheets, and data management
• Knowledge of GMP and safety requirements.
• Knowled…