Job Description

Kelly Government Solutions is seeking a Lab/Project Manager for Biopharma Process Development to work on-site in support of the Vaccine Production Program at the National Institute of Allergy and Infectious Diseases (NIAID)/National Institutes of Health (NIH) in Bethesda, MD.

This is a long-term contract position which offers:

- Competitive compensation and comprehensive benefit package

- Optional health, vision, and dental plans

- Paid leave, paid federal holidays, and 401K plan.

- Access to NIH’s unparalleled resources and niche scientific initiatives

KEY TASKS

(1) Coordinate with Vaccine Production Program (VPP) Process team directors and scientific leads to ensure laboratories are properly equipped and maintained to perform desired research and development.

(2) Perform material generation runs in the downstream process development laboratory to support critical project milestones toward IND-filing efforts such as toxicology study and/or reference standard materials

(3) Create and maintain equipment usage guidance documents including formal reference documents and SOPs

(4) Provide oversight of acquisition process and installation of capital equipment.

(5) Train and/or coordinate the training of laboratory personnel on proper equipment use and troubleshooting.

(6) Maintain real-time equipment readiness database to ensure laboratory assets are fully available for material generation, data analysis, and/or development studies

(7) Establish preventative maintenance (PM) schedule/calendar of all Process-specific equipment.

(8) Prepare and establish training protocols to bridge on the job training with proper execution and documentation.

(9) Monitor inventory levels, model usage projections, and recommend the ordering of commonly used materials.

(10) Lead coordination efforts on and implementation of materials/supply systems within the Process Team laboratories to ensure lab has inventory visibility

(11) Provide vision for lab organizational efforts and lead implementation of 5S initiatives by identifying critical initiatives and directing team efforts of all workstation supplies and consumables storage for labs.

(12) Manage inventories of equipment specific consumables and oversee buffer prep chemical and media supply levels

(13) Act as department resource on proper waste disposal, identify where training is needed, and coordinate with the safety officer

(14) Serve as liaison to scientific operations/technical services group on Process department related matters including related paperwork, service contracts and requests, procurement, and vendor visits

KEY REQUIREMENTS

(1) M.S. degree in Biochemistry, Chemistry, or related Life Science

(2) Minimum of five (5) years of experience working in a biopharma/process development environment.

(3) Minimum of three (3) years of laboratory operations management experience

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