Manufacturing Associate III (DP) - Aseptic Fill

Description

The Manufacturing Associate III (DP), is a regular full time non-exempt position at Kashiv BioSciences, LLC, in Chicago, IL. This employee will be responsible for the formulation, filtration, and aseptic filling of drug 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 BioSciences policies, procedures (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement.

Essential Duties & Responsibilities

• To prepare and update SOPs / Protocols required for the cGMP operation.
• To prepare and update training modules required for drug product manufacturing operation.
• Training of Associate I and Associate II.
• To take Line Inspection/Line clearance of ISO6, ISO7 and ISO8 area.
• To Weigh and dispensing of materials
• To operate Part washer, autoclave, filter integrity tester, and mixing system.
• Operate syringe filler, glove integrity tester and non-viable particle count.
• To calibrate and verify pH and conductivity meter and weighing scale.
• To standardize and operate the 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.
• Clean ISO5 and ISO6 area as per SOP.
• To maintain inventory (Disinfectant solution, gowns, goggles, wipes, etc.).
• To verify all raw materials and other consumables.
• Responsible for equipment 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 requests to start batch manufacturing operations to respective departments.
• 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.
• Perform reconciliation of product and solutions after completion of the batch.
• 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.

Requirements

Education:

• Associate college degree or higher college in Biology, Chemistry, Biotechnology, Pharmacy or related preferred
• Or an equivalent of 5+ years of industry experience required.
• Operation of Autoclave, filling machine, Aseptic techniques and clean room manufacturing experience 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.