The Fountain Group is currently seeking a Sr. Biomanufacturing Associate for a prominent client of ours. This position is located in Rockville, MD . Details for the position are as follows:
Sr. Biomanufacturing Associate
Location: Onsite
Pay Rate: $29.50/hr
Duration: 6 Months (Potential Extension or Conversion)
The Sr. Biomanufacturing Associate supports gene therapy manufacturing operations within a regulated cGMP environment. This role is responsible for independently executing manufacturing activities, supporting batch execution, maintaining compliance, troubleshooting process issues, and contributing to continuous improvement initiatives.
Key responsibilities:
Execute downstream processing and fill-finish manufacturing activities in accordance with approved batch records and SOPs
Coordinate and perform floor-level manufacturing operations from start to finish
Perform batch production record (BPR) reviews and ensure documentation accuracy
Prepare, operate, inspect, clean, and maintain manufacturing equipment
Support GMP audits, investigations, and root cause analysis activities
Maintain data integrity and compliance with GDP requirements
Perform cleanroom operations following aseptic techniques and gowning requirements
Handle biological materials, chemicals, and hazardous substances in accordance with biosafety standards
Support equipment calibration activities and process troubleshooting
Train and mentor manufacturing personnel on procedures and best practices
Drive continuous improvement and LEAN initiatives to improve operational efficiency
High School Diploma/GED with 6+ years of related experience; OR
Associate Degree with 5+ years of related experience; OR
Bachelor’s Degree in Biology, Life Sciences, Bioengineering, or related discipline with 3+ years of related experience
Cell and gene therapy manufacturing experience within a cGMP-regulated environment
Downstream processing and/or fill-finish manufacturing operations
GMP, GLP, GDP, and data integrity compliance
Batch Production Record (BPR) execution and review
Cleanroom manufacturing and aseptic processing
Gowning qualification and media fill activities
Deviation investigations and root cause analysis
Equipment operation, maintenance, cleaning, and troubleshooting
Biosafety procedures and hazardous material handling
GMP audit participation and quality documentation management
LEAN manufacturing and continuous improvement methodologies
Microsoft Word, Excel, PowerPoint, Teams, and manufacturing databases
Gene therapy manufacturing experience
Informal leadership, mentoring, or project coordination experience
LEAN Trainer certification or willingness to obtain certification
Experience supporting regulatory inspections and compliance initiatives
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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.