Manufacturing Media/Buffer Prep Associate

• 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.

• 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.

• 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.

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

• 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.

• 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
• 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
• $28–$34 per hour with up to a 5% yearly cash bonus

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.

• 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.

• 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.

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

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.