Manufacturing Associate II (Upstream/Downstream)

Piper Companies; Gaithersburg (MD); In loco; USD 52.000 - 80.000; Tempo pieno

Vantaggi offerti da questo lavoro

Medical coverage

Dental coverage

Vision coverage

401k plan

Sick leave

PTO

Holidays

Descrizione del lavoro

Piper Health and Sciences in Gaithersburg, MD is seeking a Manufacturing Associate II to support downstream manufacturing in a GMP environment. You will operate and maintain chromatography systems, perform tangential flow filtration and viral filtration, and work in a cleanroom.

Responsibilities include buffer and media prep, aseptic processing, documentation, and ensuring adherence to cGMP. A Bachelor's degree in a science field and 3+ years of GMP experience are required.

Competenze

• 3+ years in a GMP biotech/pharma setting, with ≥1 year in downstream manufacturing.
• Experience with chromatography, filtration, aseptic processing, and TFF.
• Ability to work in a BSC and apply aseptic techniques.
• Understanding of cGMP and related regulations.
• Bachelor's degree in a science-related field.

Mansioni

• Execute manufacturing of drug product following GMP guidelines.
• Prepare buffers and media for downstream processing.
• Operate and maintain chromatography systems for protein purification.
• Conduct tangential flow filtration and viral filtration to ensure product purity.
• Perform aseptic processing in a clean room with contamination controls.
• Maintain documentation in GMP compliance.
• Troubleshoot downstream processing equipment.

Conoscenze

GMP experience

Downstream manufacturing

Formazione

Bachelor's degree in science

Strumenti

Chromatography systems

Tangential Flow Filtration (TFF)

Biological Safety Cabinet (BSC)

Descrizione del lavoro

Piper Health and Sciences is seeking a skilled and motivated Manufacturing Associate II 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: $52,000 - $80,000 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 10/23/2026. Applications for this job will be accepted for at least 30 days from the posting date.

Keywords:

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