Manufacturing Media​/Buffer Prep Associate

Description

Company Overview

Creating a Healthier World through Accessible Biologics:

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.

Essential Duties & Responsibilities

Key responsibilities of the position include, but are not limited to –

• Accurately weigh, measure, mix, and sterile filter cell culture media and buffer solutions within a cGMP environment.
• Strictly follow current Good Manufacturing Practices (cGMP), adhere to all standard operation procedures (SOPs), comply with all company policies, and data integrity standards.
• Execute associated batch records in real-time as well as associated supporting documents/logbooks.
• Ensure batches are executed in a timely manner and maintain proper documentation practices.
• Conduct routine sampling and support in-process testing and perform Daily in-process monitoring throughout batch duration. (pH, metabolites, cell density/viability).
• Use various analytical equipment such as pH meter, conductivity meter, osmometer, scales, etc.
• Performing equipment troubleshooting, cleaning, verification, and status labelling.
• Use of programs to collect, evaluate, and review operating data to conduct on-line adjustments to instruments or equipment.
• Ability to interpret and provide instructions furnished in written, oral, diagram, or scheduled format.
• Coordinate/support with the conduction of investigations and corrections for related issues during batch execution.
• Maintain good housekeeping standards in the work area.
• Following safety procedures specific to work area, including the proper use of personal protective equipment.
• Demonstrating dependability through good attendance and adherence to timelines and schedules.
• Perform other functions as required or assigned to support manufacturing operation.

QMS, Documentation, and Compliance

• Write, revise, and execute manufacturing batch records, SOPs, Protocols and logbooks.
• Assist with opening/closing deviations, CAPAs, change controls, and investigations.
• Support quality audits and regulatory inspections.
• Ensure all operations comply with cGMP, safety, and data integrity standards.

Material & Inventory Management

• Track, request, and stage raw materials including media components, consumables, and gases.
• Perform label verification, receipt checks, and electronic inventory updates.
• Coordinate with warehouse and planning teams for material readiness.

Cross-Functional & Technical Transfer Support

• Collaborate with supporting groups such as QA, Analytical, Engineering, and Validation groups.
• Support technology transfer of new upstream processes or scale changes.
• Perform small projects independently and contribute to larger tech-transfer initiatives.
• Generate work orders and follow up in case of machine breakdown.

Requirements

Position Requirements and Qualifications

Minimum Qualifications:

Education

• High school diploma or equivalent required. Bachelor's degree preferred.

Preferred Qualifications:

• Experience in a manufacturing environment or 1-2 years of relevant experience preferred.
• Familiarity with safety protocols/procedures
• Ability to work in a team-oriented environment with cross-functional groups.
• Ability to work in a fast-paced environment and handle changing manufacturing demands.
• Excellent written and verbal communication skills. Ability to communicate technical details at all levels, including senior leadership.
• Ability to troubleshoot technical issues and propose short- and long-term solutions.
• Strong time-management skills and the ability to work under demanding timelines.
• As a biosimilar company, our schedules are driven by process requirements. The need for 24/7 coverage of manufacturing activities requires holiday/weekend coverage.
• 2+ years of Hands-on experience in biopharma or biotech manufacturing, or…