Manager I, Assay Services

Meso Scale Diagnostics, Llc   •  

Gaithersburg, MD

Industry: Healthcare


8 - 10 years

Posted 53 days ago


This position is responsible for the overall coordination, status reporting and management of multiple assay services projects. The incumbent will be responsible for coordination between external customers and internal groups to ensure assay development projects are delivered on time, within budget, adhere to quality standards and meet customer expectations.


• Assist in pre-contract and pre-sales activities as required including providing meeting notes and documentation of project definition meetings and definition of the scope of the project.
• Work with the Technical Services team to research and identify sources of material (antibodies and proteins) for proposed projects.
• Write and define a statement of work (SOW) for proof of concept and feasibility studies including:
o Define with the customer the project’s objectives, scope, and deliverables.
o Define the timeline and resource requirements for the project.
o Create a budget for the project.
• Work with legal, customer service, procurement and sales organizations to execute on Service Agreements.
• Communicate customer requirements to the internal technical and production teams.
• Maintain budgets for each project to ensure accurate financial accountability, initiate invoicing of customers on a regular basis, and provide monthly summary updates to the management team.
• Track key project/contract milestones and deliverables. Adjust project plans, schedules and resources utilizing approved change management practices to meet the requirements and needs of the customer through project completion and closeout.
• Ensure appropriate documentation is completed and manage and coordinate material transfer between the Customer and MSD.
• Coordinate production of Custom and Contract Manufacturing products between internal and external customers.
o Monitor timelines and inventory for production of Custom and Contract Manufacturing products developed through the Assay Services business.
o Track and communicate planning for production timelines.
• Assemble project proposals, plans, schedules and appropriate resource allocations.
o Define the project’s objectives, scope, goals and deliverables.
• Manage work efforts on weekly or appropriate periodic basis identifying schedule conflicts, resource needs and performing quality reviews.
o Determine resources and coordinate the efforts of team members in order to deliver projects according to plan.
• Coordinate and escalate communication with all appropriate areas of the company to mitigate the impact of changes to project scope, budget, resources and risk.
• Assist project leaders and team members in the use of project management methods, standards and tools.
• Communicate services information, pricing, and order information to prospective customers.
o Assist strategic sales team in customer education
o Assist in the documentation of customer facing materials.
• Specific duties may vary depending upon departmental or project requirements.

• Bachelor’s degree or higher in Science, Business, Engineering, or equivalent work experience
• A minimum of 7 years of experience with immunoassay development projects in multiple technologies and functions.
• Project management certification or completion of a recognized project management curriculum or equivalent work experience desired but not required.
• A minimum of 2 years’ experience in a services organization and preferably in a clinical testing laboratory or contract research organization.
• Experience in life science, GMP, government contracting or other regulated industry desired.


• Strong analytical background.
• Demonstrate a thorough understanding of the principles of immunoassays, their development, and their applicability in different research fields.
• Logical problem solving and demonstrated ability to organize and move project tasks forward in an orderly and structured fashion.
• Excellent oral, written communication and interpersonal skills.
o Effectively communicate issues/problems and results that impact timelines, accuracy and reliability of project data.
o Effectively communicate project expectations to team members and stakeholders in a timely and clear fashion.
• Proficiency in MS Office Suite; MS Project experience desired
o Experience with standard data analysis tools (Excel, GraphPad Prism) and the quantitative background to advance this knowledge on the job is expected.
• Ability to work with inter-departmental teams including Operations, Customer Service, Legal, Assay Development, and Quality Assurance/Control.
• A wide degree of creativity and latitude is expected including the ability to multi-task and work productively in a demanding financial environment with changing priorities.