Experience

Metagenomi

• United States
• Biotechnology Research
• 100 - 200 Employee

• DIrector, Process Engineering, Tech-Ops

  • Aug 2021 - Present



SanBio, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Associate Director, Process Development and Validation

  • Jul 2020 - Aug 2021



Boehringer Ingelheim

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Process Engineer, Cell Culture and Purification

  • Oct 2017 - Jul 2020

  • Lead upstream and downstream process/tech transfers for assigned (internal/external) projects at 2K/12K scale.• Provide scientific and technological support during process transfers, launch and initial supply, while leading troubleshooting, continuous improvement and contingency strategies in support of GMP operations.• Technical lead in monitoring, analyzing and evaluating at-scale process data and trends.• Act as the technical interface between at-scale MFG and the customer (or Process Sciences)• Develop process models and contribute to the design and planning of small-scale studies in collaboration with Process Science during transfer and at scale production.• Support new product evaluations for upstream and downstream processes – this involves initial facility fit, new material needs, modification/new equipment needs and supporting RFP drafts.• Authors and reviews technical documentation such as; process descriptions, engineering run protocols, product/process impact assessments in support of deviation closure and specific sections of CMC dossiers (i.e. IMPDs, INDs and BLAs.)• Audit support, i.e. technical preparation and responses to inspection observations. • Served as a temporary software architect for redesign of automation (using S88 principles) to better fit a multi-product facility.• Active in training and mentoring new/junior process engineers through transferring best practices, lessons learned and project support.• Direct reports include interns and contingent workers. Show less

• Process Engineer, Cell Culture

  • Oct 2015 - Oct 2017

  • Lead upstream process/tech transfers for assigned (internal/external) projects at 2K/12K scale.• Provide scientific and technological support during process transfers, launch and initial supply, while driving troubleshooting, continuous improvement and contingency strategies related to production activities.• Act as the technical interface between at-scale MFG and the customer (or Process Sciences)• Develop process models and contribute to the design and planning of small-scale studies in collaboration with Process Science during transfer and at scale production.• Support new product evaluations for upstream processes – this involves initial facility fit, new material needs, modification/new equipment needs and supporting RFP drafts.• Support filing submissions i.e. IMPD, IND, NDA and BLA’s.• Audit support, i.e. technical preparation and responses to inspectional observations. • Support deviation investigation and closure as process SME with technical assessments and memo’s drafted as needed.• Active in training and mentoring new/junior process engineers through transferring best practices, lessons learned and project support. Show less

• Cell Culture, Lead Master Associate

  • Sep 2014 - Oct 2015

  - Manufacturing upstream operations supervisor; ensuring all daily production activities have been completed.- Train and assist with the development of junior staff.- Assist and conduct complex "troubleshooting"​ related to production (e.g., technical, equipment, and process performance issues.- Assist with long term forecasting regarding the annual production schedule and resource planning.- Drive continuous improvements of business, operational and manufacturing processes.- Collaborate with process science in the planning of small scale studies and internal improvement projects.- Collaborate and support E&T regarding internal improvement projects, detailed facility fits for NPI's and validation activities.- Cross-functionally work with other companies to complete tech/process transfers for NPI's.- Create/Update manufacturing batch records and SOPs for re-supply campaigns and new product campaigns.- Subject matter expert for clients and or regulatory agencies Show less

• Cell Culture, Senior Associate

  • Oct 2013 - Sep 2014

  - Train new hires on cell culture manufacturing operations for GMP drug substance production in stainless steel bioreactors. - Support single use bioreactor operations for toxicology runs for new products and GMP campaigns. - Work with equipment engineers, process engineers, validation and scientists to complete tech transfers and drive new product introduction activities. This includes commissioning and process qualification activities along with the generation of process descriptions, batch records and updates to SOPs.- Assist with scheduling, audit preparation, client tours, change controls and deviations/non-conformance reports.- Use six sigma and lean principles to drive process improvements and efficiencies. - A member of a small group known as the flexible work force which provides support to multiple departments and undertake multiple short term projects. Show less



Boehringer Ingelheim GmbH

• Cell Culture Associate Scientist

  • Apr 2013 - Oct 2013

  - Assist in the design of cell culture studies; to characterize and further optimize mammalian cell culture for the production of monoclonal antibodies, with respect to product yield and quality.- Independently plan, schedule and perform experiments for new biological entities, client biologics and biosimilars.- Present experimental results at internal department meetings and cross functional team meetings.- Assist in new product introduction and tech transfer projects.- Support laboratory organization with regards to supplies along with the maintenance and troubleshooting of instrumentation when required. - Prepare process description protocols and reports in support of transferring the process to the GMP facility.- Work with vendors to test and assess new equipment and instrumentation which can further enhance the departments ability to characterize mammalian cell culture. Show less

• Cell Culture Manufacturing Associate

  • Jan 2012 - Apr 2013

  - Routinely perform manual and automated operations related to large scale mammalian cell culture such as sterile/aseptic inoculations and harvest operations, while adhering to cGMP’s.- Analyze cells using a variety of analytical laboratory equipment. - Qualified to disassemble and reassemble Alfa Laval Centrifuges. - Perform hazard analysis and risk assessments on new equipment.- Collaborate with validation department to validate CIP and SIP cycles for new processes and provide technical insight for user/functional requirement specification write-ups. - Revise SOPs, create training material and design process readiness kits for specific cell culture operations.- Review controlled documents such as equipment use logs and batch records and perform equipment changeover for compliance; ensuring upstream equipment is ready new product campaigns.- Use multiple enterprise resource and planning systems such as SAP and MES; to keep track of inventory used during operations and write up deviations/non-conformance reports. Show less



ImmunePath, Inc

• ImmunePath, Inc

• Internship

  • Jun 2011 - Oct 2011

  - Research into increasing the yield of platelets from the directed differentiation of hematopoietic stem cells - Design vectors to be used in E.coli expression systems to produce specific cytokines in vitro. - Culture and freezing of bacterial, mammalian and stem cells - Purify and analyze protein using affinity chromatography, SDS-PAGE and western blotting. - Design and perform cell based assays testing bio activity of cytokines - Automate cell based assays using a Tecan robotic systems Show less



Brightex Biophotonics, LLC.

• San Jose

• Assistant to Director of Engineering and Director of Marketing

  • Mar 2011 - Oct 2011

  Research and Marketing - Research into fluorescent techniques which could be utilized by the company in the future. - Interpreting skin fluorescence data and using it to write up study reports. - Testing and analysis of software performance. - Creating instruction manuals, ensuring they are simple and end user friendly. - Designing marketing material to be used in conferences, exhibitions and presentations. - Developing company and brand awareness through contacting clients and social networking. - Carrying out product testing studies for research purposes. Show less