Tiny Cargo - Manufacturing Technician

A little bit about us…

The Tiny Cargo Company's mission is to unlock the healing power of milk-derived exosomes. We're building a new frontier in targeted drug delivery through our proprietary IP in exosome isolation, loading, and drug development, and we're commercializing pharmaceutical- and cosmeceutical-grade exosomes to help fund that work as we scale.

We're a small, fast-moving team based in Roanoke, and every hire we make right now shapes how this company operates for years to come. That means the people who join us early get real ownership, real trust, and a real hand in building something from the ground up.

A little bit about the role…

The Manufacturing Technician executes cleanroom production of milk-derived extracellular vesicles alongside our manufacturing team, working across every unit operation from raw material receipt through purification, lyophilization, and packaging, plus the cleaning, monitoring, and documentation that keep our cleanroom certified and cGMP compliant.

This position exists to build a second qualified operator on every unit operation, freeing up senior staff from routine bench execution. Independent qualification across the full process is the expectation for your first year, and it's the foundation for the promotion path that follows. We're hiring for two of these seats on the team, so you'd be stepping in alongside a peer doing the same work, reporting to the Manufacturing Manager.

The Manufacturing Technician will be responsible for…

Production Execution

• Executing manufacturing steps per approved batch records across raw material receipt, clarification, tangential flow filtration, chromatographic purification, lyophilization, fill, and packaging
• Preparing buffers and process solutions to specification
• Setting up, operating, and monitoring process equipment and automated isolation systems, and escalating excursions and faults promptly
• Performing equipment changeover, cleaning, and sanitization, and supporting cleaning verification sampling
• Performing in-process sampling and routine in-process testing, including cleaning verification and environmental monitoring sampling

Documentation & Compliance

• Completing batch record entries contemporaneously and legibly
• Performing, monitoring, and maintaining environmental monitoring records supporting cleanroom certification
• Reporting events, excursions, and discrepancies immediately, and supporting deviation investigations with accurate, factual accounts
• Receiving, inspecting, staging, and accounting for incoming materials, and maintaining quarantine status until released to use
• Supporting deviation investigations with accurate, factual accounts through the corrective and preventive action (CAPA) process
• Maintaining equipment logbooks, cleaning records, incoming inspection records, and material transaction records

Materials & Facility

• Receiving, staging, and accounting for incoming materials, and maintaining quarantine status until released to use
• Maintaining consumable and reagent stock levels and flagging reorder points through a Kanban system
• Segregating and disposing of waste per procedure, and maintaining gowning and hygiene standards
• Owning the lab's chemical hygiene program for the production facility
• Maintaining cleanroom and warehouse spaces in a certified, compliant state

Training & Development

• Completing the training and qualification curriculum for each unit operation, including procurement and supply chain, and maintaining current records in the QMS
• Progressing toward independent qualification across all unit operations within your first year, verified by the Manufacturing Manager
• Supporting training of subsequent technicians once qualified

We are excited about you because you…

Bring hands-on lab or manufacturing experience

• Hold an Associate or Bachelor of Science degree in Biology, Biochemistry, Engineering, or equivalent practical experience
• Have wet laboratory or manufacturing experience with aseptic technique
• Are comfortable working gowned in a cleanroom and physically handling materials, including standing for extended periods and lifting

Operate with precision and reliability

• Take documentation seriously, keeping contemporaneous, accurate, and complete records for every operation you perform
• Follow approved procedures exactly, especially where the work supports cGMP compliance
• Show up ready to learn the process end to end; prior cGMP or cleanroom experience is a plus but not required, since the process is taught in post
• Bring demonstrable care and accuracy in record keeping, treating documentation as a core part of the job, not an afterthought 

Bring curiosity and problem-solving to the process

• Are naturally curious, asking why a process works the way it does rather than just following steps
• Notice when equipment or a process isn't behaving the way it should, and think through the fix rather than waiting to be told
• Are a strong problem-solver who can prioritize competing demands, a batch that needs to move, a vendor issue, an equipment fault, and know what to tackle first
• Are comfortable taking a shot on a decision with incomplete information, learning quickly, and correcting course rather than waiting until everything is certain

We're especially excited if you…

• Have experience in biotechnology, pharmaceutical, or food-grade processing
• Are familiar with quality management or laboratory information systems
• Have experience with filtration, chromatography, or lyophilization equipment
• Bring an engineering background or a mechanically inclined, process-troubleshooting mindset

Reasons it pays to work at The Tiny Cargo Company (in addition to the pay itself)…

• Health insurance stipend or policy 
• Standard federal holidays and paid time off + sick leave
• Workers' compensation insurance coverage 
• Reimbursement for work-related expenses 

Studies have shown that women and people of color are less likely to apply to jobs unless they meet every single qualification. At Tiny Cargo, we are dedicated to building a diverse, inclusive and just workplace. If you’re excited about this role but your past experience doesn’t align perfectly with 100% of the qualifications listed, we encourage you to still apply.