Alveo Technologies is the first company to make molecular detection and diagnostics universally accessible – on the farm, in the field, in the clinic, or in the manufacturing plant – helping prevent or significantly limit the destructive impact of viruses, fungi, bacteria, and other pathogens by detecting earlier at the Point of Need™. Alveo’s rugged and portable, multiplex-capable diagnostic platform employs IntelliSense™, its patented method of direct electrical sensing of nucleic acid amplification to provide affordable, rapid, and accurate results. By enabling early pathogen detection, Alveo helps manage global health, food security, and supply chain resiliency by providing actionable insights at lightspeed. Know Sooner, Act Faster™ with Alveo. For more, visit: https://www.alveotechnologies.com/

Alveo is looking for a highly skilled reagent manufacturing professional with a proven track record of production support. The Reagent Manufacturing Engineer will lead efforts to bring reagents into manufacturing, be heavily involved in troubleshooting process problems and developing solutions to resolve/mitigate risks, and lead efforts to scale reagent manufacturing. The ideal candidate will have prior, demonstrated experience developing, testing, implementing, troubleshooting formulation automation using a requirements-driven approach in a clinical laboratory or other molecular biology-based laboratory setting. He or she will also apply engineering, molecular biology, and/or biochemistry knowledge to troubleshoot manufacturing issues.

Act as the point person in leading technology transfer, including process and equipment, from R&D into Manufacturing Operations as part of a phase-gate product development structure.

Implement variable-build-volume manufacturing methods, scaling of reagent manufacturing, and develop supporting process documentation and tools.

Prepare documentation to support PLM, ERP, and MES and perform COGs analysis for new reagent products

Review processes and documentation to drive towards minimization in lot-to-lot performance variation, improvement in first pass and overall yield, and effective scaling to support anticipated demand.

Support production by training manufacturing associates, creating and maintaining product and process documentation, and implementing process improvements that increase yield, efficiency, and/or throughput.

Execute verification and validation processes and prepare product documentation

Provide user requirements to project teams to ensure manufacturability of processes/methods.

Develop, characterize, and optimize processes using statistical techniques and engineering knowledge and experience.

Coordinate with suppliers and other external resources needed in developing and implementing process improvement plans.

Provide sustaining support, including troubleshooting, process improvement, and new equipment specifications.

Assist in non-conformance investigation and CAPA closure. Develop raw material and QC specifications for new Assays that will be transferred to Manufacturing, and closely work with the QC group.

Help to create product FMEAs (Failure Mode and Effects Analysis) and proactively identify, manage and escalate product and project risks and issues to relevant stakeholders.

Be involved in cross-functional root cause analysis and troubleshooting efforts.

Support Supply Chain with supplier selection, development, qualification, and management and support Alveo's quality team management of supplier quality

Develop detailed manufacturing throughput models to allow accurate estimation of labor, equipment and facilities requirements based on various product roadmap scenarios (product mix/volume estimates)

Lead equipment assessment, acquisition, and qualification to support reagent and buffer manufacturing scale-up, optimize mixing methods, implement component volume metered dispensing, and filtering of dry-wet chemical mixes to ensure no agglomerated particles in final mix.

Maintain manufacturing processes in validated state.

Develop key performance indicators (KPIs) and monitor progress.

Lead 5S and continuous improvement projects.

Bachelor's degree with a focus on chemical engineering, bioengineering, or a closely related discipline and 5-10 years of related experience.

5+ Years related experience in a GMP/GLP formulations/compounding lab required.

Experience in streamlining workflows and developing robust manufacturing processes.

Extensive experience with liquid reagent formulations and scale up with utilization of automation.

Experience working within regulated environments (FDA, ISO, etc.) is required.

Must be able to work in a fast-paced environment, managing multiple competing priorities and assignments with the ability to plan and deliver against deadlines

Strong computer, scientific, and organizational skills with attention to detail

Experience with statistical data analysis, monitoring data quality, and troubleshooting technical problems.

Effective communication and collaborative skills, working with internal and external colleagues and customers from diverse scientific, engineering, operational, and regulatory disciplines.

Strong laboratory skills including pipetting, safety, and hazardous materials handling, and working in a BSC is required

Experience with dry-down reagent techniques is a plus.

Experience in iso-thermal amplification methods and developing POC product is desirable.

Familiar with cell and nucleic acid amplification assays

Extensive understanding of basic laboratory equipment

Basic knowledge of Lean initiatives

Salary range for this position is $115,000 - $150,000 per year

We are an equal opportunity employer and value diversity at Alveo Technologies. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.