• Became de facto downstream manufacturing supervisor with 6 direct reports.• Assessed performance and made recommendations for direct report growth and satisfaction.• Facilitated the transition from two distinct teams of downstream and upstream into one lean manufacturing group, with the intention of maximizing cross training opportunities to increase flexibility amongst all operators. • Performed FAT and IQ on new equipment with aggressive deadlines.• Created and authored Bills of Material for new campaigns. • Created production schedules and coordinated with supporting departments (QA, QC, Materials) to adhere to these schedules. •Performed downstream purification processes (chromatography, viral inactivation and filtration, UF/DF, final bottling), component weighing and mixing per SOP’s and BPR’s compliant with cGMP’s. • Proficient in UNICORN operation and authoring UNICORN scripts on AKTA chromatography skids.• Led projects to prepare facility for incoming clinical campaigns, including authoring new batch and solution records, designing and scheduling manufacturing operations, authoring Unicorn scripts, opening and closing production suites and ensuring equipment readiness.• Performed successful and concise root cause analysis to close deviations and ensure a further robust process.

• Worked at Biogen-Idec for Kelly Services, converted to permanent on September 2011. • Executed protein purification and manufacturing operations exact to specifications on appropriate SOPs and cGMPs to manufacture biologics consistently, effectively, and safely• Authored deviations and performed root cause analysis.• Volunteered to become TFF subject matter expert on shift, troubleshooting and operating ultrafiltration skids with no deviations, and performing root cause analysis and CAPA’s on deviations along with product impact assessments• Cross-trained in component weighing, buffer mixing, cell culture operations with stainless steel equipment (2k Liter scale) and production support in a cGMP environment. • Spearheaded first viral inactivation and final bottling for commercial process on night shift.• Teamed up with Manufacturing Sciences and Engineering and authored a new training manual for incoming purification operators that yielded more effective training, increased safety awareness, and provided a deeper overall understanding of protein purification processes for all operators.