Overview
On Site
USD 60,000.00 - 75,000.00 per year
Full Time
Skills
Media
Documentation
Regulatory Compliance
GMP
Biotechnology
Pharmaceutics
Chromatography
Aseptic Technique
Balanced Scorecard
Good Manufacturing Practice
Science
Manufacturing
Law
Job Details
Piper Health and Sciences is seeking a skilled and motivated Manufacturing Associate II (Downstream) to join a biopharmaceutical company in the Gaithersburg, MD area. The Manufacturing Associate II is a crucial role in supporting the downstream manufacturing team. This position involves operating and maintaining downstream processing equipment, performing filtration and chromatography techniques and supporting production activities in a cleanroom environment.
Responsibilities of the Manufacturing Associate II:
Execute manufacturing of drug product following GMP guidelines
Perform buffer and media preparation for downstream processing.
Operate and maintain chromatography systems for protein purification.
Conduct tangential flow filtration (TFF) and viral filtration to ensure product purity.
Perform aseptic processing in a clean room environment, adhering to strict contamination control measures.
Maintain accurate documentation of manufacturing activities in compliance with GMP regulations.
Troubleshoot and resolve issues related to downstream processing equipment.
Qualifications of the Manufacturing Associate II:
3+ years of professional experience working in a GMP environment (Biotechnology or Pharmaceutical organization) with 1+ years of experience working in downstream manufacturing
Experience performing chromatography, filtration techniques, aseptic processing, TFF (tangential flow filtration)
Experience demonstrating aseptic technique and ability to work in a BSC (biological safety cabinet)
Understanding of cGMP (current Good Manufacturing Practices)
Bachelor's degree in science related field
Compensation for the Manufacturing Associate II:
Salary: $60,000 - $75,000 annually, commensurate with experience
Comprehensive Benefits: Medical, Dental, Vision (through Cigna), 401k, Sick leave required as by law, PTO, Holidays
This job opens for applications on 05/16/2025. Applications for this job will be accepted for at least 30 days from the posting date.
Responsibilities of the Manufacturing Associate II:
Execute manufacturing of drug product following GMP guidelines
Perform buffer and media preparation for downstream processing.
Operate and maintain chromatography systems for protein purification.
Conduct tangential flow filtration (TFF) and viral filtration to ensure product purity.
Perform aseptic processing in a clean room environment, adhering to strict contamination control measures.
Maintain accurate documentation of manufacturing activities in compliance with GMP regulations.
Troubleshoot and resolve issues related to downstream processing equipment.
Qualifications of the Manufacturing Associate II:
3+ years of professional experience working in a GMP environment (Biotechnology or Pharmaceutical organization) with 1+ years of experience working in downstream manufacturing
Experience performing chromatography, filtration techniques, aseptic processing, TFF (tangential flow filtration)
Experience demonstrating aseptic technique and ability to work in a BSC (biological safety cabinet)
Understanding of cGMP (current Good Manufacturing Practices)
Bachelor's degree in science related field
Compensation for the Manufacturing Associate II:
Salary: $60,000 - $75,000 annually, commensurate with experience
Comprehensive Benefits: Medical, Dental, Vision (through Cigna), 401k, Sick leave required as by law, PTO, Holidays
This job opens for applications on 05/16/2025. Applications for this job will be accepted for at least 30 days from the posting date.
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