Job Description

The Manufacturing Associate I (DS) is a regular employee in a full-time non-exempt position at Kashiv BioSciences, LLC, in Chicago, IL.

The Manufacturing Associate is a hands-on production position responsible for the manufacturing of Biotechnology products for clinical and commercial human use. The employee is responsible for executing upstream fermentation and downstream purification processes for a range of microbial-based biosimilars. Employee applies aseptic techniques while working in controlled and classified environments, which require cleanroom gowning and some aseptic gowning. Must comply with Kashiv BioSciences policies, procedures (SOPs), FDA current Good Manufacturing Practices (cGMP), and any other government requirements.

Essential Duties & Responsibilities

· Follow work instructions, production specifications, and standard operating procedures (SOPs) to perform key responsibilities and maintain quality data while meeting production goals and timelines and minimizing downtime/delays. Work instructions include but are not limited to:

• Weighing and dispensing of materials
• Media and buffer preparation
• Operation of filtration systems (such as dead-end filtration, depth filtration, tangential flow filtration)
• Inoculation, fermentation, harvest, and homogenization of cytokine cells
• Setup and operation of chromatography columns
• Aseptic final filtration of intermediates and drug substances
• Monitor product for quality output using PLC controls, HMI interfacing, integrity testing, and in-process testing (pH, Conductivity, and Spectroscopy).
• Properly handle and discard hazardous materials (i.e., buffers, chemicals, etc.) in accordance with EHS guidelines. Remove used and soiled materials from manufacturing areas.
• Follow daily and weekly cleaning routines for cleanrooms and equipment to maintain the required conditions for cleanroom manufacturing.
• Track, request, stage, and verify raw materials and commodities; accurately enter raw material and commodities data in MES on a daily basis
• Completes Batch Records and other cGMP documentation accurately and in a timely manner in compliance with good documentation practices, including but not limited to ALCOA++.
• Revision of solution preparation batch records, SOPs, protocols, and logbooks
• Provides support during quality audits and regulatory inspections
• Reports nonconformances or events that arise during the shift to the Supervisor
• Complies with all safety, cGMP and Company policies, practices and procedures.
• Performs other functions as required or assigned

Requirements

Position Requirements and Qualifications:

Education and Experience

• Associate degree or higher in Biology, Chemistry, Biotechnology, or related preferred OR high school diploma and 1-2 years of industry experience required
• Aseptic techniques and cleanroom manufacturing experience are preferred.

Knowledge, Skills, Abilities:

· Ability to understand and adhere to written and verbal instructions

· Ability to understand technical information, procedures, batch records, and other documents in English.

· Ability to learn properly and efficiently using various hand and electrical tools.

· Ability to work in a fast-paced environment and handle manufacturing demands and priorities. The schedule is driven by process requirements. The need for support of manufacturing activities may run through weekends or outside of normal shift hours.

· Excellent interpersonal skills, effective communication with peers and supervision.

· Reasoning Skills

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

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

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

· Computer and/or Technical Skills

o Basic computer skills, including Microsoft Word, Excel, and PowerPoint

o Operation and understanding of data management software

o Skills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc.

o Knowledge of GMP, GDP and safety requirements.

o Knowledge of biotechnology operations such as Aseptic Filtration Systems, Aseptic Sampling, Filter Integrity Testing, Fermentation Process, Inoculation Process, Chromatography Columns, Mixing systems, Weigh Scales, etc.

WORKING ENVIRONMENT/PHYSICAL REQUIREMENTS:

· General Work Environment: GMP Clean rooms and Laboratories

· Noise Quiet to Loud (35 – 85 dB)

· Standing/Lifting

o Must be able to move around the facility to reach various equipment

o Physical lifting and shifting required for pushing and pulling containers

o Must be able to lift at least 25 lbs. Frequent moving of 25-50 lbs. on carts.

o Frequent moving of 100-250 lbs. with assistance.

o Must be able to stand for long periods of time

o Occasional bending, squatting, kneeling, stooping, pushing, pulling, reaching.

o Frequent repetitive motions.

· Handwriting: Manufacturing processes require extensive documentation in accordance with current Good Manufacturing and Good Documentation Practices. Such documentation must be produced in a manner that is both neat and legible.

· Visual No extraordinary requirements.

· Stress High-paced, demanding environment to meet ambitious project goals.

· Travel Limited to no travel

Additional Position Information:

• Manufacturing shift hours: Shift A (first shift): 06:00 AM to 2:30 PM EST, Shift B (first shift): 9:00 AM to 5:30 PM EST (first 14 days), Shift C (second shift): 2:00 PM to 10:30 PM EST, and Shift D (third shift): 10:00 PM to 6:30 PM EST. Overtime (time and a half pay), holidays, and weekends will be required based on process requirements.

• Compensation: These are hourly FTE positions with overtime eligibility and shift differentials for applicable evenings.

* Manufacturing Associate I (0–2 years or more of biologics manufacturing experience): $26-$30 per hour with up to a 5% yearly (discretionary) cash bonus

* Manufacturing Associate II (2–4 years or more of biologics manufacturing experience): $30–$38 per hour with up to a 5% yearly (discretionary) cash bonus

* Manufacturing Associate III (3–5 years or more of biologics manufacturing experience): $38–$45 per hour with up to an 8% yearly (discretionary) cash bonus

• Kashiv BioSciences is able to provide sponsorship support for qualified candidates. Please let us know if you currently require sponsorship or may require sponsorship in the future.

• Interviews and employment are conducted onsite at our Chicago, IL facility. Candidates should currently reside within a reasonable commuting distance or be planning to relocate to the area.

Supervisory Responsibility, if any: No

This position description is not a complete list of all responsibilities, duties, or skills 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.

Kashiv BioSciences, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability, or genetics. In addition to federal law requirements, Kashiv BioSciences, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation, and training.