Product Transfer Associate I

MESO SCALE DIAGNOSTICS, LLC.•Rockville, MD

5d•$45,500 - $66,000•Onsite

About The Position

This position is responsible for manufacturing assay kit components during development phases, meeting production schedules and troubleshooting. The role is cross-disciplinary and requires coordination across multiple departments (Operations, Quality, Research & Development, etc).

Requirements

Bachelor degree in Biology, Chemistry, Biotechnology, Engineering or related field, or associate’s degree with equivalent experience.
One year of relevant experience desired.
Demonstrate an aptitude for learning new processes, collaborating with multiple departments , adhering to standard laboratory techniques and safety precautions as presented
Knowledge of scientific fundamentals and possess a strong analytical background
Knowledge of automated equipment function and use
Mechanical aptitude including equipment troubleshooting
Excellent oral, written communication and interpersonal skills
Proficiency using MS Office
Ability to multi-task and work productively in a demanding manufacturing environment with changing priorities

Nice To Haves

Experience working independently in manufacturing or research lab highly preferred
Knowledge of MRP or ERP systems preferred
Knowledge of JDE preferred
Knowledge of cGMP and/or ISO 9001 standard is highly preferred

Responsibilities

Manufacture custom and/or prototype requests for internal and external customers.
Operate multiple production lines (Plate, Reagent and/or BioChemical manufacturing).
Assist with operating and troubleshooting automated equipment used to perform and produce biological assays/reagents.
Contribute to process improvement, assay and process development for new and existing products.
Provide complete documentation that supports process and production procedures that includes, but is not limited to data entry, form creation, log entries, and inventory batch records.
Assist with drafting of standard operating procedures and batch records for new products, if necessary.
File deviations, variances and non-conformance reports as needed.
Assist with development of presentations/reports regarding product development issues for internal use.
Maintain laboratory cleanliness, supplies and equipment.
Perform daily maintenance and documentation for all production equipment.
Maintain physical inventory by processing/aliquotting/vialing/labeling materials.
Prepare, maintain and report raw material, reagent and/or coated plate inventories.
Participate in year-end physical inventory.
As needed, provide training to Operations colleagues on new processes.
May occasionally handle BSL2 reagents.
Specific duties may vary depending upon departmental requirements.
Assist production groups during periods of high demand.