Manufacturing Associate I (DS) Rotating 1st and 2nd Shift

Manufacturing Associate I (DS)

Kashiv Bio Sciences, LLC is a fully integrated biopharmaceutical company. Kashiv Bio Sciences, LLC in the United States, and its subsidiary, Kashiv Bio Sciences Private Limited in India (together "Kashiv Bio Sciences"), 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 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 Bio Sciences policies, procedures (SOP), FDA current Good Manufacturing Practices (cGMP), and any other government requirement.

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.
• 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 clean rooms 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 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

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 is 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 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.
• Comp…