Job Details

Pay range: 24-28/hr
*depending on experience

Position Overview

The Manufacturing Associate II 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 – ASSOC I:
Qualifications

Education & Experience

· Bachelor’s degree in Biotechnology, Biochemistry, Chemical Engineering, Life Sciences, or a related discipline with 0-2 years of relevant experience.

· High School Diploma/GED with 4+ years of relevant biopharmaceutical manufacturing experience may be considered.

Required Skills

· Basic understanding of biologics purification and downstream processing.

· Ability to follow detailed manufacturing procedures.

· Strong attention to detail and documentation practices.

· Effective communication and teamwork skills.

· Knowledge of cGMP requirements is preferred.

Preferred Skills

Experience with:

· Chromatography systems
· Tangential Flow Filtration (TFF)
· Buffer preparation
· AKTA chromatography platforms
· Single-use technologies
· Aseptic processing