Experience

A-BIO

• United States
• Biotechnology Research
• 1 - 100 Employee

• Project Engineer II

  • Jun 2021 - Present

  - Manage and/or provide project support from conception, design, and implementation through qualification and operational readiness. - Support Factory and Site Acceptance Testing (FAT, SAT), startup and commissioning activities as required. - Develop and manage productive working relationships with project team members and stakeholders, including client staff, vendors, etc. - Facilitate project team meetings, including scheduling, planning and tracking. - Develop and execute field… Show more - Manage and/or provide project support from conception, design, and implementation through qualification and operational readiness. - Support Factory and Site Acceptance Testing (FAT, SAT), startup and commissioning activities as required. - Develop and manage productive working relationships with project team members and stakeholders, including client staff, vendors, etc. - Facilitate project team meetings, including scheduling, planning and tracking. - Develop and execute field plans for construction, contractor oversight, and other project activities. - Field survey and data collection supporting engineering projects/initiatives. - Facilitate and participate in design review. - Management and delivery of contractor turnover packages. - Engineering drawing management for redline, revision, etc. Show less - Manage and/or provide project support from conception, design, and implementation through qualification and operational readiness. - Support Factory and Site Acceptance Testing (FAT, SAT), startup and commissioning activities as required. - Develop and manage productive working relationships with project team members and stakeholders, including client staff, vendors, etc. - Facilitate project team meetings, including scheduling, planning and tracking. - Develop and execute field… Show more - Manage and/or provide project support from conception, design, and implementation through qualification and operational readiness. - Support Factory and Site Acceptance Testing (FAT, SAT), startup and commissioning activities as required. - Develop and manage productive working relationships with project team members and stakeholders, including client staff, vendors, etc. - Facilitate project team meetings, including scheduling, planning and tracking. - Develop and execute field plans for construction, contractor oversight, and other project activities. - Field survey and data collection supporting engineering projects/initiatives. - Facilitate and participate in design review. - Management and delivery of contractor turnover packages. - Engineering drawing management for redline, revision, etc. Show less



Catalent Pharma Solutions

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Associate Scientist III - Process Development AAV Production

  • May 2019 - May 2021

  - Upstream process development team leader directly responsible for process optimization/scale up of multiple suspension platform transient transfection AAV manufacturing processes in single use systems. o Experience at shake flask, 2L, 10L, 25 and 50L rocker wave, and 200L bioreactors. o Successfully scaled up and transferred processes to manufacturing team. o Generated batch records for upstream process, and presentations/reports to update clients and manufacturing team. … Show more - Upstream process development team leader directly responsible for process optimization/scale up of multiple suspension platform transient transfection AAV manufacturing processes in single use systems. o Experience at shake flask, 2L, 10L, 25 and 50L rocker wave, and 200L bioreactors. o Successfully scaled up and transferred processes to manufacturing team. o Generated batch records for upstream process, and presentations/reports to update clients and manufacturing team. o Optimized harvest/clarification steps to increase yield returns. o Responsible for creating all upstream Process Flow Diagrams for process to be transferred to manufacturing. - Worked alongside scientist to fully optimize and develop a transient transfection AAV production process in an adherent platform. o Initial optimization and development done at T-Flask scale. o Used ImageJ analysis to better quantify cell growth at T-Flask stage. o Suited process to Pall iCELLis bioreactor platform at the iCELLis nano bioreactor scale. o Process was successfully scaled up to PALL iCELLis 500 scale and transferred to manufacturing. - Worked on design to re-engineer iCELLis Nano lid tubing assembly to minimize off-line manipulations to improve the process efficiency and minimize risk of contamination. - Performed kLA studies on single use 2L, 50L, 200L, iCELLis nano, and iCELLis 500 bioreactors to better optimize scaling of AAV production for the PD upstream team for both suspension and adherent processes. - Utilize SAS JMP to interpret process development data and communicate directly with CDMO clients regarding the design and performance of their process. - Engaged in scientific decision-making processes with scientists and clients by actively collaborating in scientific and technical data review. - Communicated with client in CDMO setting and adjust scope and details of project to meet the clients’ urgent timeline needs. Show less - Upstream process development team leader directly responsible for process optimization/scale up of multiple suspension platform transient transfection AAV manufacturing processes in single use systems. o Experience at shake flask, 2L, 10L, 25 and 50L rocker wave, and 200L bioreactors. o Successfully scaled up and transferred processes to manufacturing team. o Generated batch records for upstream process, and presentations/reports to update clients and manufacturing team. … Show more - Upstream process development team leader directly responsible for process optimization/scale up of multiple suspension platform transient transfection AAV manufacturing processes in single use systems. o Experience at shake flask, 2L, 10L, 25 and 50L rocker wave, and 200L bioreactors. o Successfully scaled up and transferred processes to manufacturing team. o Generated batch records for upstream process, and presentations/reports to update clients and manufacturing team. o Optimized harvest/clarification steps to increase yield returns. o Responsible for creating all upstream Process Flow Diagrams for process to be transferred to manufacturing. - Worked alongside scientist to fully optimize and develop a transient transfection AAV production process in an adherent platform. o Initial optimization and development done at T-Flask scale. o Used ImageJ analysis to better quantify cell growth at T-Flask stage. o Suited process to Pall iCELLis bioreactor platform at the iCELLis nano bioreactor scale. o Process was successfully scaled up to PALL iCELLis 500 scale and transferred to manufacturing. - Worked on design to re-engineer iCELLis Nano lid tubing assembly to minimize off-line manipulations to improve the process efficiency and minimize risk of contamination. - Performed kLA studies on single use 2L, 50L, 200L, iCELLis nano, and iCELLis 500 bioreactors to better optimize scaling of AAV production for the PD upstream team for both suspension and adherent processes. - Utilize SAS JMP to interpret process development data and communicate directly with CDMO clients regarding the design and performance of their process. - Engaged in scientific decision-making processes with scientists and clients by actively collaborating in scientific and technical data review. - Communicated with client in CDMO setting and adjust scope and details of project to meet the clients’ urgent timeline needs. Show less



Paragon Bioservices, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Associate Scientist II

  • Nov 2017 - May 2019

• Associate Scientist I

  • Jun 2016 - Nov 2017

  Microbial Process Development Operate and maintain bioreactors at 20L, 40L, 100L, and 300L scales for clients in a CRO setting for use in the biopharmaceutical industry. • Experienced in scale-up, feed, inactivation, and media optimization studies of multiple microbial organisms. • Familiar with producing tech transfer documents, batch records, and SOPs for microbial processes, using GDP. • Work with Eppendorf DASGIP software used to operate the 4 x 1L bioreactors for scale-up… Show more Microbial Process Development Operate and maintain bioreactors at 20L, 40L, 100L, and 300L scales for clients in a CRO setting for use in the biopharmaceutical industry. • Experienced in scale-up, feed, inactivation, and media optimization studies of multiple microbial organisms. • Familiar with producing tech transfer documents, batch records, and SOPs for microbial processes, using GDP. • Work with Eppendorf DASGIP software used to operate the 4 x 1L bioreactors for scale-up studies. • Responsible for gathering, analyzing, and compiling data in PowerPoint format for upcoming client meetings. • Attend client meetings and offer opinions on future fermentation processes. • Routinely perform downstream processes and analysis including TFF, diafiltration, continuous centrifugation in CEPA/Sharples, SDS-page gels, western blots, CFUs, and phage assays. • Help maintain and troubleshoot the NOVA Bioprofile 300B. • Conduct inventory for projects and performed purchasing orders. • Successfully completed GMP training, which included SOP reading and hands on SOP training. • Supported the GMP microbial upstream manufacturing team and helped a fermentation process transition from PD to GMP.



Bioprocess Scale-up Facility at the University of Maryland

• Senior Lab Technician

  • 2015 - 2016

  Senior Lab Technician - Responsible for overseeing bioproduction process from upstream to downstream. - Managed schedules and tasks for other technicians during processes. - Communicate progress to lab manager and clients

• Lab Technician

  • Jun 2014 - 2015

  Work aseptically under Bio Safety Cabinet. Skilled with fermentation and scale up process - Fermentation with 10L, 100L, and 250L bioreactor - Establish batch records and SOPs for clients - Familiar with GMP documentations and protocols Experience with downstream process - Centrifugation - Ultrafiltration/Diafiltration - Chromatography – HIC and Ion Exchange