About this opportunity
Kashiv BioSciences LLC lists this Manufacturing Associate I (DS) - 3rd shift opportunity in chicago, Illinois. Review the employer’s description below for duties, qualifications and application requirements.
Job description
Manufacturing Associate I (DS)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.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 (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement.Essential Duties & ResponsibilitiesFollow 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 materialsMedia and buffer preparationOperation of filtration systems (such as dead end filtration, depth filtration, tangential flow filtration)Inoculation, fermentation, harvest, and homogenization of cytokine cellsSetup and operation of chromatography columnsAseptic final filtration of intermediates and drug substancesMonitor 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 daily basisCompletes 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 logbooksProvides support during quality audits and regulatory inspectionsReports nonconformances or events that arise during the shift to the SupervisorComplies with all safety, cGMP and Company policies, practices and procedures.Performs other functions as required or assignedRequirementsAssociate degree or higher in Biology, Chemistry, Biotechnology or related preferred OR high school diploma and 1-2 years of industry experience requiredAseptic techniques and cleanroom manufacturing experience is preferred.Knowledge, Skills, Abilities:Ability to understand and adhere to written and verbal instructionsAbility 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 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 SkillsThe 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 processesAbility to work independently, within prescribed guidelines, or as a team member and the demonstrated ability to follow detailed directions.Computer and/or Technical SkillsBasic computer skills, including Microsoft Word, Excel, and PowerPointOperation and understanding of data management softwareSkills for working with Computer systems, such as: Delta, PCR, POMS, LIMS, SAP, etc.Knowledge of GMP, GDP and safety requirements.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 LaboratoriesNoise: Quiet to Loud (35 – 85 dB)Standing/Lifting:o Must be able to move around the facility to reach various equipmento Physical lifting and shift required for pushing and pulling containerso 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 timeo 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 product 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 travelAdditional 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 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 bonusManufacturing Associate II (2–4 years or more of biologics manufacturing experience): $30–$38 per hour with up to a 5% yearly (discretionary) cash bonusManufacturing Associate III (3–5 years or more of biologics manufacturing experience): $38–$45 per hour with up to an 8% yearly (discretionary) cash bonusKashiv 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.Benefits/Perks:Medical Insurance - AetnaPrescription Drug Converge | RxVirtual Visits - Aetna/TeladocHealth Savings Accounts (HSA)Flexible Spending Accounts (FSA)Dental Insurance - AetnaVision Insurance - VSPLife and AD&D InsuranceDisability BenefitsSupple
Worksite address
chicago, IL, 60616, US
Who can apply
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