Jobs · Analyst · Illinois

Manufacturing Associate I / II (DP) – Rotating 1st and 2nd Shift - Aseptic Fill

Kashiv BioSciences LLC · Chicago, IL · 1 mo ago
Analyst$24–$30/hrFull-time
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    for prose. Do not repeat job title as heading. Do not put Job ID/requisition numbers as headings. Remove boilerplate, navigation, legal, EEO, etc. Preserve all substantive info. Include a section only when posting has real, specific content for it—no filler. Avoid sections with placeholder like "commensurate with experience". Pay and Schedule sections only if posting actually states them. The posting includes compensation details (hourly rates) and shift hours. So we can include Pay and Schedule sections. We need to parse content: Company Overview: description of Kashiv BioSciences. Could be "About the role"? Actually "Company Overview" could be considered "About the role"? The instruction: use

    for section headings (e.g. About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule). So we can have sections: About the role (maybe includes company overview and position summary). Responsibilities (Essential Duties & Responsibilities). Requirements (Position Requirements and Qualifications: Minimum Qualifications). Qualifications (Preferred Qualifications). Skills (maybe combine with qualifications? But we can have separate Skills section for technical skills). Benefits (list of benefits). Pay (compensation details). Schedule (shift hours). Also maybe "Working Environment/Physical Requirements" could be part of Requirements or Skills? But we can include under Requirements or maybe a separate section? The instruction only lists those headings; we should not create extra headings not listed. So we need to fit content into those headings. We can put working environment under Requirements or Skills? Probably under Requirements (since it's about qualifications). Or we could put under Skills? But better to put under Requirements as it's about physical requirements. We must not include boilerplate like EEO, supervisory responsibility, etc. We must preserve all substantive information. So we need to include details from company overview, position summary, essential duties, requirements (minimum qualifications), preferred qualifications, skills (computer/technical skills), benefits, pay, schedule. We must not invent or summarize away detail. So we need to keep specifics like shift times, hourly rates, bonus, etc. We need to format lists with
    • . For prose use

      . We need to avoid duplication. Let's extract content: 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 Manufacturing Associate I / II is a regular employee / or contract 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. 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 (list): - 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. Requirements (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) of industry experience required. Operation of Autoclave, filling machine, Aseptic techniques, and clean room manufacturing experience 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: - General Work Environment: GMP Clean rooms and Laboratories - Noise: Quiet to Loud (35 – 85 dB) - Standing/Lifting: Must be able to move around the facility to reach various equipment. Physical lifting and shift required for pushing and pulling containers. Must be able to lift at least 25 lbs. Frequent moving of 25-50 lbs. on carts. Frequent moving of 100-250 lbs. with assistance. Must be able to stand for long periods of time. Occasional bending, squatting, kneeling, stooping, pushing, pulling, reaching. 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 travel Additional Position Information: - Manufacturing shift hours: Shift A (first shift): 06:00 AM to 2:30 PM CST, Shift B (first shift): 9:00 AM to 5:30 PM CST (first 14 days), Shift C (second shift): 2:00 PM to 10:30 PM CST, and Shift D (third shift): 10:00 PM to 6:30 AM CST. 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): $24-$30 per hour with up to a 5% yearly (discretionary) cash bonus Manufacturing Associate II (2–4 years or more of biologics manufacturing experience): $28–$34 per hour with up to a 5% 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. Benefits/Perks list: - Medical Insurance - Aetna - Prescription Drug Converge | Rx - Virtual Visits - Aetna/Teladoc - Health Savings Accounts (HSA) - Flexible Spending Accounts (FSA) - Dental Insurance - Aetna - Vision Insurance - VSP - Life and AD&D Insurance - Disability Benefits - Supplemental Benefits - Legal Services - ID Theft Protection - Travel Assistance - Value Added Benefits & Services - Health Advocate - Life Assistance Program (LAP) - Student Loan Assistance Program - 401K - Monthly Cell Phone Allowance - Free Parking (Company Paid) - Conveniently located next to the Metra, Green and Red Line - One block east of the Chicago White Sox Stadium - Less 10 minutes away from Downtown Chicago We need to exclude boilerplate like EEO, supervisory responsibility, etc. Now we need to map to sections: About the role: Could combine Company Overview and Position Summary. Provide a

      with that info. Responsibilities: list of essential duties. Requirements: Minimum Qualifications (education/experience). Could also include Working Environment/Physical Requirements? Might be better to put under Requirements as it's about qualifications/physical ability. But we have also a Skills section for technical skills. Let's decide: - Requirements: Minimum Qualifications (education/experience) plus maybe Working Environment/Physical Requirements? But the instruction says we can have sections: About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. So we have separate Requirements and Qualifications and Skills. So we should put: Requirements: Minimum Qualifications (education/experience). Possibly also include "Operation of Autoclave, filling machine, Aseptic techniques, and clean room manufacturing experience is preferred." That's a qualification but could be under Requirements or Qualifications. Since we have Qualifications section for Preferred Qualifications, we can put the "preferred" experience under Qualifications. So Requirements will be just the minimum: Associate degree or higher in Biology, Chemistry, Biotechnology, Pharmacy, or related preferred OR equivalent of 1-4 years industry experience required. Qualifications: Preferred Qualifications (Language, Reasoning Skills, Computer/Technical Skills). Could also include the preferred experience (operation of autoclave etc.) but that is already mentioned under Minimum Qualifications as preferred. Might be redundant but we can include it under Qualifications as well. However we should not duplicate content unnecessarily but we can include if it's part of preferred qualifications. The posting says under Minimum Qualifications: "Operation of Autoclave, filling machine, Aseptic techniques, and clean room manufacturing experience is preferred." That's a preferred qualification. So we can include that under Qualifications. Skills: Could be the Computer And/or Technical Skills subset? But we already have Computer skills under Qualifications. Perhaps we can separate: Qualifications includes Language, Reasoning Skills, and maybe the preferred experience; Skills includes Computer/Technical Skills and maybe other technical

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