Manufacturing Associate

Manufacturing Associate I, II or II (depending on experience)

Location: 100% onsite in Pennington, NJ

Duration: 6 month contract, potential for extension or conversion

Schedule: 1st or 2nd shift

These positions require a lot of flexibility – may require OT, evening work, overnight work, weekends, & holidays.

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Position Overview

The Manufacturing Associate will be responsible (or lead, depending on level) for the day-to-day operations of downstream processing in a clean room environment. This role includes buffer and media preparation, chromatography, tangential flow filtration (TFF), viral filtration, and aseptic processing.

Key Responsibilities:

· Buffer and Media Preparation: Prepare and maintain buffers and media required for downstream processes. Ensure accurate formulation and timely availability of all solutions. Maintain detailed records of preparation and usage.

· Chromatography: Operate and maintain chromatography systems for protein purification. Monitor process parameters and ensure consistent product quality. Troubleshoot and resolve any issues that arise during chromatography runs.

· Tangential Flow Filtration (TFF): Perform TFF operations for concentration and diafiltration of biopharmaceutical products. Optimize TFF parameters to achieve desired product specifications. Document all TFF activities and results.

· Viral Filtration: Conduct viral filtration to ensure the safety and purity of biopharmaceutical products. Validate and monitor viral filtration processes. Maintain compliance with regulatory standards for viral safety.

· Aseptic Processing: Perform aseptic processing in a clean room environment. Adhere to strict aseptic techniques to prevent contamination. Ensure compliance with Good Manufacturing Practices (GMP).

· Clean Room Operations: Maintain a clean and organized work environment. Follow all clean room protocols and procedures. Participate in regular clean room maintenance and cleaning activities.

· Documentation and Compliance: Maintain accurate and detailed records of all manufacturing activities. Ensure compliance with GMP and regulatory requirements. Participate in audits and inspections as needed.

· This is a full-time non-exempt position (40 hours/week) involving a standard schedule and requires availability to work flexible shifts including overtime, evenings, weekends and holidays, as operational needs require.

· Other duties as assigned.

Qualifications

· Education and Experience: Bachelor's degree in biotechnology, Biochemistry, Chemical Engineering, or a related field with 1-3+ years of relevant experience. H.S diploma with 4+ years of experience will be considered in lieu of Bachelor's Degree.

· Skills: Ability to follow instructions and procedures. Experience with buffer and media preparation, chromatography, TFF, viral filtration, and aseptic processing a plus. Excellent problem-solving and analytical skills. Effective communication, leadership and teamwork abilities. Strong knowledge and experience working in a biopharmaceutical cGMP- regulated environment. This position requires the ability to stand for extended periods, bend, and lift objects weighing up to 50 pounds. Candidates must be physically capable of performing these tasks safely and effectively.

· Communication: Strong verbal communication skills and documentation skills required. Must be able to speak clearly to convey information to others. Timely follow-up and response is required.

Physical Demands

· This job includes sitting, standing, walking, using hands/fingers for typing and handling documents, reaching, and maintaining close vision for computer work.

· Must have clarity of vision for distances of 20 feet or more, necessary for recognizing hazards or reading signage.

· In addition to working a laboratory setting, this job functions in an open office setting using standard office equipment such as computers, phones, calculators, copiers, fax machines, and file cabinets.

· This job has repetitive motion repeated movements of the hands, wrists, or fingers, such as typing and using laboratory equipment.

· This job may require stooping, kneeling or crouching for accessing files in lower cabinets or performing other tasks.

· This position requires the ability to stand for extended periods, bend, and lift objects weighing up to 50 pounds.