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Downstream GMP Manufacturing Associate

The Fountain Group LLC

Rockville, MD

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JOB DETAILS
SALARY
SKILLS
Asepsis, Biological Processes, Biology, Chromatographic Systems, Chromatography, Cleanroom, Communication Skills, Current Good Manufacturing Practice (cGMP), Documentation, Editing, GMP (Good Manufacturing Practices), Gene Therapy, High School Diploma, Manufacturing, Manufacturing/Industrial Processes, Microsoft Management Console (MMC), Operational Support, Operations Processes, Production Control, Production Support, Production Systems, Standard Operating Procedures (SOP), Team Player
LOCATION
Rockville, MD
POSTED
7 days ago
Details for the position are as follows:
  • 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.

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About the Company

T

The Fountain Group LLC

The Fountain Group provides Contingent Labor, Statement-of-Work, and Contingent-to-Permanent resources to clients with an internal/external Contingent Labor Managed Service Program or Clients without a program. The Fountain Group is committed to the belief that we all share in the responsibility to conduct our businesses in a socially and environmentally responsible manner. We base this on the premise that a company is much more than the products it offers. The effect a company has on the environment, the people and the communities it serves reflects the company’s dedication to being not only a good business, but to being a good corporate citizen. The Fountain Group believes the key to servicing a client is to identify the client demand precisely. Therefore, The Fountain Group focused its efforts on building and developing a process, which can identify an exact match for our client’s needs. Our process utilizes modern technology combined with 30+ years of Talent Acquisition experience to deliver Precision resources. Financial strength is prominent among The Fountain Group’s corporate values. The future of our business will be built on the innovation, compassion, outstanding services and technology, but a solid financial foundation is required to carry us forward to meet our business goal and support our long term vision.

COMPANY SIZE
500 to 999 employees
INDUSTRY
Staffing/Employment Agencies
WEBSITE
https://www.thefountaingroup.com/

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