Competent self starter seeking biotechnology product development position requiring strong technical and analytical skills in a positive team environment
I currently work at Arbor Vita where I collaborate with the Quality, Manufacturing, and Research teams to facilitate critical projects relating to multiple aspects of process development (conceptual design, proof of concept, validation, optimization, troubleshooting), resulting in developing and validating new stabilized reagents leading to an 85% reduction in cost of goods from the current reagent. I’ve also contributed to the qualification of FDA-cleared A/H7N9 Influenza Rapid test and CE-marked OncoE6 Cervical Test. Additionally, I currently analyze and summarize obtained data in addition to developing required and comprehensive Standard Operating Procedures.
Developed and optimized new stabilized reagent without altering the specificity and sensitivity of rapid test leading to a 85% reduction in cost of goods from the current reagent
Developed reagents and contributed to the qualification of ligand-binding immunoassays, including FDA-cleared A/H7N9 Influenza Rapid Test and CE-marked OncoE6™ Cervical Test
Developed and implemented manufacturing processes for stabilizing reagents of rapid tests including recombinant proteins, conjugated antibodies, and mucolytic agent
Responsibilities:
Facilitate critical projects/research initiatives relating to multiple aspects of assay development (conceptual design, proof of concept, validation, optimization, qualification, troubleshooting) - Spearhead the formulation, process, packaging, and equipment design in addition to producing reagents with different formats and stabilization processes - Develop feasibility study protocol, produce pilot lot, evaluate performance, and create feasibility reports to demonstrate production process’s ability to deliver a product that meets the established acceptance criteria - Create required and comprehensive Standard Operating Procedures (manufacturing instructions, equipment procedures, specifications, and drawings) to ensure consistent outcomes and decreased error rates - Produce validation lots in order to evaluate lots performance and construct validation reports to demonstrate manufacturing process’s replicability and ability to consistently meet established acceptance criteria - Optimize formulation of stabilized reagent by producing different formulations and evaluating performance in order to identify and select the ideal formulae - Write, improve, and execute installation, operation, and performance qualification procedures in addition to ensuring the proper calibration and qualification of the equipment according to intended use - Collaborate with team members to create list of problems, develop root cause analyses, and implement corrective and preventative actions
Optimize, improve, and simplify SOPs, installation, operation, and performance qualification protocols according to intended setting and use in addition to improving manufacturing instructions and equipment procedures
Developed and optimized a new stabilized reagent without altering the specificity and sensitivity of rapid test leading to a 85% reduction in cost of goods from the current reagent
Responsibilities:
Facilitate critical projects/research initiatives relating to multiple aspects of assay development (conceptual design, proof of concept, optimization)
Develop technical reports and documentation of experimental details, plans, interpretations, and conclusions in order to present and communicate key findings to team members by maintaining detailed records and accurately recording usage of equipment/material
Critically analyze and summarize obtained data to draw scientifically correct and relevant conclusions in order to articulate scientific interpretations and results on a weekly basis
