Alere Inc.Senior Research Scientist - Antibody Development
Jan. 2011 - Dec. 2015Greater San Diego AreaI managed a team of three Research Associates in developing recombinant protein purification processes for use in manufacturing and led the transfer of new processes at cGMP pilot to production scale (2L to 350L). I served as lead scientist for the Global Alere Reagent Business and designed the technology and process transfer strategy for antibodies, enzymes and peptides produced from bacterial and mammalian expression systems. I created, developed, and maintained all technical documentation, including technical sections for 510ks with successful Regulatory submissions in the US, Japan, and Africa I provided technical expertise and advised cGMP manufacturing teams on process improvements, resulting in over $70M in cost-savings annually. Furthermore, I developed antigens, antibodies and enzymes for use in various medical and diagnostic applications such as cardiology, oncology, women’s health, drugs of abuse, and infectious diseases (Influenza, HIV, HSV, and MRSA).