Experience

Concuir, Inc

• United States

• Senior Engineer

  • Jun 2022 - Present

  -Managing various projects simultaneously to meet project deliverable, goals, and budget needs. -Leads the management of process, product, and equipment life cycle management activities. -Leads and oversee Chemistry, Manufacturing, and Controls (CMC) project management activities for Investigational New Drug (IND) Submissions. -Provide technical support to analyze and assess complex issues to determine a plan of action for resolution(s) and preventative measure(s). -Leads and manages engineers to drive project success while establishing relationships with clients and vendors. -Works cross-functionally between departments and project teams to create a collaborative workspace, update stakeholders, and meet project deadlines. -Support and improve operations activities, programs, and documentation across various departments. -Executes gap analysis on equipment and processes to address and remediate issues to mitigate future risks in operations and business. -Plans and execute FDA remediation projects to spotlight the root cause and address the compliance issues, remediate the concerns, and provide a plan of action for necessary changes. Show less



Kato Pharmaceuticals

• Senior Chemical Engineer

  • Sep 2021 - May 2022

  -Assessed, planned, designed, and commissioned Class 8 and 7 clean rooms with Class 5 areas for aseptic processing (Fill and Finish); work force utilization, space requirements, workflow, and design layout of equipment and workspace for efficiency and prevention of risks. -Lead the procurement, commissioning, maintenance, and operations of manufacturing equipment.-Executed tech transfers of manufacturing process for liposome drug product and continuous glucose monitor device. -Developed and reviewed engineering documents such as process maps, process FMEA, Manufacturing/Quality Instructions, test methods, drawings, and test reports. -Provided leadership and/or project management within the Manufacturing group and/or cross-functionally in projects or other teams as needed.-Delivered and/or managed projects assigned and works with other engineers to achieve desired results; Test Method Validation (TMV), Benchtop Studies, Design of Experiments (DOE), Process Validations, etc.-Designed, developed, analyzed, troubleshooted, and provided technical skills during research and/or product development. Show less

• R&D and Manufacturing Engineer

  • Apr 2018 - Sep 2021

  -Developed scaled up manufacturing processes by studying product requirements, researching, designing, modifying, and testing manufacturing methods and equipment.-Lead the identification, evaluation, selection, procurement, installation, qualification, and maintenance of manufacturing equipment. Worked with the Technical Data Package and management to develop process.-Lead/ assisted in Continuous Improvement (CI) Projects, including identification of opportunities, research literature and vendors, and developed and executed projects, all following appropriate change control methodologies.-Develop, lead, and managed shelf-life stability activities and schedules while executing release and routine analytical testing of the drug product to maintain compliance. -Managed projects and successfully delivered while working with other engineers to achieve desired results; Test Method Validation (TMV), Benchtop Studies, Design of Experiments (DOE), Process Validations, etc. to optimize scaled processes.-Prepared product and process reports by generating data, collecting data, analyzing, and summarizing information and trends to draw conclusions. -Lead deviation investigations to identify root causes and define corrective and preventive actions (CAPAs)-Assisted in tech transfers of manufacturing processes for liposome drug products to licensing partners outside of the US. Show less



Metronom Health

• United States
• Medical Equipment Manufacturing
• 1 - 100 Employee

• Senior Chemical Engineer

  • Sep 2021 - May 2022

  This is a hybrid position for Kato Pharmaceuticals and Metronom Health -Lead and executed Process Transfer activities including working instructions, batch records, equipment qualification documents and suggested improvements where possible. -Developed and executed qualification documents for custom manufacturing and testing equipment including but not limited to URS, SRS, DS, IQ/OQ protocols and reports, SOP, etc. -Provided detailed specifications for proposed solutions including time and scope involved. Work with a team of engineers to provide timely and meaningful results. -Analyzed current technologies used within the company and developed steps and processes to improve testing procedures to reduce variations and optimize output on custom testing equipment. -Developed and performed Measurement System Analysis (MSA – Gage R&R) and ensure testing is robust and that the test results are insensitive to the operator performing the test. -Responded to process and instrument failures to minimize downtime and result variations. -Determined resolution of intermediate technical issues as needed and assures that technical work meets specified requirements. -Knowledge on CGM sensors. -Knowledge on polymers and hydrogels Show less


Bachem
• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee
• Chemist II

  • Oct 2017 - Mar 2018

Hologic, Inc.
• United States
• Medical Equipment Manufacturing
• 700 & Above Employee
• Process Development Chemist

  • Aug 2015 - Oct 2017


South Dakota State University

• United States
• Higher Education
• 700 & Above Employee

• Research Intern

  • May 2013 - Aug 2013

  •Studied the process design and controls for the production of bio-oils via fast pyrolysis and the production high quality bio-fuel using a Hydrodeoxygenation (HDO) reactor. •Designed and developed an integrated process consisting of a pyrolysis reactor and Hydrodeoxygenation (HDO) reactor to prove optimization in the production of high quality bio-fuels in a continuous flow system. •Executed various batches producing a range of quality oils and bio-fuels by altering the complexity of the process conditions, catalyst mixture(s), and biomass materials. •Used state-of-the-art analytical equipment to study the properties of crude bio-oils and high quality bio-fuels. •Developed the knowledge to understand, operate, and interpret results of analytical equipment to perform data analysis. •Adhered to the concepts of Good Laboratory Practices (GLP) while performing R&D activities into a laboratory notebook. •Attended seminars and workshops to improve laboratory skills, safety, protocols, and overall professional development. Show less



Hampton University

• United States
• Higher Education
• 700 & Above Employee

• Research Intern

  • Jan 2013 - Apr 2013

  •Worked collaboratively with members and Department Heads to develop and design an experiment. •Participated on the proposal to retrieve funding for the project. •Conducted trials of the experiment to evaluate the properties of chitin, specifically in periwinkle shells, for further experimental analysis. •Analyzed and implemented alternative methods to adjust the chitin properties to satisfy our theory. •Worked collaboratively with members and Department Heads to develop and design an experiment. •Participated on the proposal to retrieve funding for the project. •Conducted trials of the experiment to evaluate the properties of chitin, specifically in periwinkle shells, for further experimental analysis. •Analyzed and implemented alternative methods to adjust the chitin properties to satisfy our theory.