Manufacturing Media/Buffer Prep Associate in Piscataway, New Jersey at Kashiv Biosciences LLC

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.

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.

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 experience supporting cGMP operations and commercial exposure, is a plus.
• Experience with single-use bioreactors, media/buffer prep, aseptic operations, and in-process sampling.
• Strong technical skillset or understanding of cell culture and/or purification operations involved with mammalian cell manufacturing.
• Proficient in MS Word, Excel, PowerPoint, and basic statistical tools.
• Excellent written and verbal communication skills.
• Ability to troubleshoot technical issues and propose short- and long-term solutions.

Additional Position Information:

• As a biologics/biosimilars company, our schedules are driven by process requirements.
• Manufacturing Operations is 12hr shifts for 24/7 coverage (2-2-3 work schedule), including holidays and weekends. Shift A (day shift): 7:00 AM to 7:00 PM EST and Shift B (night shift): 7:00 PM to 7:00 AM EST.
  • Initial training may be performed on the day shift
• Required Overtime (time-and-a-half pay), holidays, and weekends.
• During the interview process, please let us know whether you have a preference for the day shift, the night shift, or are open to both.
• Compensation: These are hourly FTE positions with overtime eligibility and shift differentials for applicable evenings.
• Manufacturing Associate I (0–2 years of biologics manufacturing experience):
  • $28–$34 per hour with up to a 5% yearly cash bonus

Work Environment & Physical Demands

General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines. Some travel may be involved.

General Work Environment:

• Work in clean rooms and laboratories.
• Work at a desk doing computer work (reading, editing, writing documents) is also required.
• Protective eye gear required.
• All work is performed inside areas that are adequately lit, ventilated, and heated.
• Potential for chemical odor and dust exists.

Standing/Lifting:

• Must be able to move around the facility to reach various equipment.
• Physical lifting and shifting required for pushing and pulling pre-made buffer containers
• Must be able to lift at least 25 lbs. to lift weights onto scale for daily scale verification
• Must be able to stand for long periods of time.
• Frequent lifting/moving of approximately 25-50 lbs.
• Frequent transporting of approximately 100-250 lbs. buffer drums on casters with assistance.
• Occasional bending, squatting, kneeling, stooping, pushing, pulling, reaching, and walking.
• Frequent repetitive motion.

Stress:

• High-paced, demanding environment to meet ambitious project goals.

Handwriting:

Manufacturing requires a lot of documentation, and as per cGMP rules, writing should be neat and legible.

Supervisory Responsibility, if any: N/A

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.