Research Operations Lead for New Assay Programs

MESO SCALE DIAGNOSTICS, LLC.; Gaithersburg (MD); On-site; USD 101,000 - 155,000; Full time

Job summary

Meso Scale Diagnostics, LLC. is seeking an operations leader responsible for implementing and managing operations for new assay services and products developed within the research group.

You will help develop and implement operational plans and manage teams to ensure successful launches and sustainable operation. The role involves coordinating verification and validation, scalable reagent production, training on new protocols, and partnering with QA, marketing and sales to deliver high‑quality

Qualifications

• Bachelor’s degree in Science, Engineering, or equivalent work experience.
• Master’s degree or PhD strongly preferred.
• At least four years of experience with immunoassay testing and/or development.
• Minimum one year of supervisory experience.
• Experience in regulated life sciences environments or government contracting is desired.
• Project management certification or curriculum is a plus.
• Experience in research/clinical-focused services is preferred.

Responsibilities

• Coordinate verification and validation plans for new offerings with QA.
• Coordinate scalable reagent production and QC processes.
• Transfer large-scale reagent manufacturing to production teams and manage inventory.
• Oversee transfer of new assay protocols to testing teams and ensure training.
• Collaborate with marketing and strategic sales for materials and proposals.
• Oversee customer projects to meet timelines, budgets, and quality standards.
• Collaborate with legal, procurement and sales on service agreements.
• Manage cross-functional project teams to deliver projects per plans.
• Identify issues and implement plans to mitigate impact.
• Determine resource needs and align resources with forecast.
• Perform quality reviews of deliverables for compliance.
• Ensure smooth transition of methodologies to production/testing teams.
• Support research in development of new services/products.
• Manage and coach operations staff to meet metrics and goals.

Skills

Immunoassay knowledge

Project management

Leadership

Cross-functional collaboration

Quality assurance understanding

Analytical skills

Regulatory/compliance awareness

Education

Bachelor’s degree in Science or Engineering

Master’s degree or PhD preferred

Job description

Meso Scale Diagnostics, LLC. is seeking an operations leader responsible for implementing and managing operations for new assay services and products developed within the research group.

You will help develop and implement operational plans and manage teams to ensure successful launches and sustainable operation. The role involves coordinating verification and validation, scalable reagent production, training on new protocols, and partnering with QA, marketing and sales to deliver high‑quality