Manufacturing Media & Buffer Prep Associate - 12-Hour Night Shift
hcfa.fa.us2.oraclecloud.com/KashivUSCareers · Piscataway, New Jersey, United States
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.
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.
- 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 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.
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.
The hourly rate for this position ranges from $25.00 to $30.00 per hour. In addition, Kashiv BioSciences, LLC., offers a short-term incentive opportunity, such as a bonus or performance-based award with this position within the first 12 months. Kashiv BioSciences, LLC., ranges reflect the Company’s good faith estimate of what Kashiv BioSciences, LLC., reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, experience, geographic location and other relevant skills.
At the heart of our Total Rewards commitment is a comprehensive, flexible and competitive benefits program for eligible positions that enables you to choose the plans and coverage that meet your personal needs. This includes above-market, diverse and robust health and insurance benefits to meet the varied needs of our employees as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life’s many other commitments and opportunities.