Downstream GMP Manufacturing Associate

The Fountain Group; Rockville (MD); On-site; USD 27,552 - 41,328; Full time

Job summary

The Fountain Group is seeking a Downstream GMP Manufacturing Associate in Rockville, MD. This position involves supporting purification operations for gene therapy products, ensuring high-quality production in a strict GMP environment.

Responsibilities include performing purification activities, preparing and sanitizing equipment, and documenting all processes accurately. Applicants should have relevant educational backgrounds and some experience in downstream biologic production.

This is a 6-month contract role requiring onsite work, offering a competitive rate of $23.50 an hour.

Qualifications

• 1-2 years of experience in downstream biologic production processes within a GMP-regulated Life Sciences company.
• Basic knowledge and understanding of purification processes.
• Experience editing and reviewing Production Batch Records and Standard Operating Procedures preferred.

Responsibilities

• Support purification operations for clinical and commercial-stage gene therapy products.
• Perform downstream purification activities including Chromatography, TFF, Ultracentrifugation.
• Document all activities in Batch Records and related documentation.

Skills

Downstream biologic production processes

Purification processes

Chromatography systems experience

Buffer preparation

Education

High School Diploma or Associate Degree

Bachelor of Science in relevant life science degree

Tools

AKTA chromatography systems

Job description

Details for the position

• Rate: $23.50 an hour
• 6-month contract to start - Temp to possible perm.
• Location: Rockville, MD – 100% onsite
• Core hours M - F 8:30 am to 5 pm with flexible hours/shifts needed

Job Description

• The Downstream GMP Manufacturing Associate will work as part of a team supporting purification operations used to manufacture clinical and commercial-stage gene therapy products. This role applies biological, bioprocess, and mechanical principles to execute complex manufacturing activities in a cGMP-regulated cleanroom environment while following aseptic techniques, SOPs, and Batch Production Records (BPRs).
• Train on and perform downstream purification activities including Chromatography, Tangential Flow Filtration (TFF), Ultracentrifugation, and Final Formulation steps.
• Work in a cleanroom environment while adhering to Standard Operating Procedures (SOPs) and Batch Production Records (BPRs).
• Prepare, sanitize, and disinfect equipment to prevent microbial contamination.
• Monitor processes using automated production systems and controls with supervision.
• Obtain and perform in-process sampling.
• Prepare buffers and solutions needed for downstream activities, including large-scale preparations (>20L).
• Perform various filter integrity tests throughout the manufacturing process.
• Document all activities in Batch Records, Logbooks, Forms, and related documentation.
• Follow verbal and written procedures when operating production equipment and performing processing steps; accurately complete all required production documentation.
• Effectively communicate and collaborate with team members to ensure completion of daily activities.
• Operate manual and semi-automated equipment in support of routine production with minimal supervision.
• Edit and review Production Batch Records and Standard Operating Procedures.
• Interact with other departments to complete activities associated with downstream operations.
• Perform other duties as assigned to support GMP Manufacturing and ensure sustainable right-first-time performance.

Required Skills

• High School Diploma or Associate Degree with 1–2+ years of experience in downstream biologic production processes within a GMP-regulated Life Sciences company; OR Bachelor of Science in relevant life science degree with 0–1+ years of experience in downstream biologic production processes within a GMP-regulated Life Sciences company.
• Basic knowledge and understanding of purification processes.
• Ability to gain hands-on experience with chromatography systems (AKTA systems at different scales) and purification approaches including Affinity, IEX, and MMC.
• Ability to learn and operate manual and semi-automated equipment supporting routine production activities with supervision.
• Experience preparing buffers and solutions.
• Experience editing and reviewing Production Batch Records and Standard Operating Procedures preferred.