Job Description

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.

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

• 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

Position Requirements and Qualifications:

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

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

o Physical lifting and shift 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 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 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): $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:

• 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

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 comply 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.