Experience

Novavax

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Bioprocess Engineer III (MS&T)

  • Apr 2023 - Present

  Gaithersburg, Maryland, United States Develop, oversee, lead: Manage CAPAs, Change Controls, OOS events and Deviations originating from and being implemented to CMO sites Author internal quality systems, risk assessments, control strategy documents, regulatory filings, and other CMC documentation Support all Tech-Transfer activities within the organization Effectively convey information to internal and external customers Track metrics across manufacturing sites to identify trends and… Show more Develop, oversee, lead: Manage CAPAs, Change Controls, OOS events and Deviations originating from and being implemented to CMO sites Author internal quality systems, risk assessments, control strategy documents, regulatory filings, and other CMC documentation Support all Tech-Transfer activities within the organization Effectively convey information to internal and external customers Track metrics across manufacturing sites to identify trends and opportunities for improvement Meet with key Novavax stakeholders to gain alignment on CMC strategy Facilitate risk assessments and other cross-functional meetings and teams Work closely with project managers at both Novavax and CMOs to ensure project milestones are maintained Other duties assigned as needed

• Bioprocess Engineer II (MS&T)

  • Jul 2021 - Apr 2023

  Gaithersburg, Maryland, United States Develop, oversee, lead: Manage CAPAs, Change Controls, OOS events and Deviations originating from and being implemented to CMO sites Author internal quality systems, risk assessments, control strategy documents, regulatory filings, and other CMC documentation Support all Tech-Transfer activities within the organization Effectively convey information to internal and external customers Track metrics across manufacturing sites to identify trends and… Show more Develop, oversee, lead: Manage CAPAs, Change Controls, OOS events and Deviations originating from and being implemented to CMO sites Author internal quality systems, risk assessments, control strategy documents, regulatory filings, and other CMC documentation Support all Tech-Transfer activities within the organization Effectively convey information to internal and external customers Track metrics across manufacturing sites to identify trends and opportunities for improvement Meet with key Novavax stakeholders to gain alignment on CMC strategy Facilitate risk assessments and other cross-functional meetings and teams Work closely with project managers at both Novavax and CMOs to ensure project milestones are maintained Other duties assigned as needed



Regeneron

• United States
• Biotechnology
• 700 & Above Employee

• Process Sciences Associate

  • Sep 2019 - May 2021

  Albany, New York Area Supports the Process and Analytical Sciences Department through small scale laboratory experiments, as well as analysis, troubleshooting, and validation of manufacturing bioprocesses. Essential Duties and Responsibilities may include, but are not limited to, the following: • Performs product impact assessment • Performs scientific investigations (EOE & DNF) • Develops and writes protocols for manufacturing support activities • Serves as a subject matter expert (SME) for data… Show more Supports the Process and Analytical Sciences Department through small scale laboratory experiments, as well as analysis, troubleshooting, and validation of manufacturing bioprocesses. Essential Duties and Responsibilities may include, but are not limited to, the following: • Performs product impact assessment • Performs scientific investigations (EOE & DNF) • Develops and writes protocols for manufacturing support activities • Serves as a subject matter expert (SME) for data trending and manufacturing support activities • Presents findings at group and possibly at interdepartmental meetings • Communicate information on current process data and other IOPS initiatives which may impact process development and/or technology transfer • Applies statistical process control tools in monitoring the manufacturing process. • Investigates OOS and OOL IPCs • Participates in process and quality risk assessments • Presents process monitoring data to IOPS Management as necessary • Assists in troubleshooting activities associated with the manufacturing process • Supports off-site transfer activities as needed • Reviews and/or approves Manufacturing documentation associated with the transferred process

• Biotech Production Specialist

  • Apr 2018 - Sep 2019

  Albany, New York Area • Performed all aspects of large scale drug production related to cell culture, aseptic upstream and downstream manipulations. • Reviewed, edited, and completed batch records, Logbooks, and SOPs in accordance with cGMP standards and written procedure. • Participated in equipment start-up, commissioning, and validation activities. • Gathered, trended, and analyzed process generated data. • Created process evaluation reports, process transfer documentation, and process… Show more • Performed all aspects of large scale drug production related to cell culture, aseptic upstream and downstream manipulations. • Reviewed, edited, and completed batch records, Logbooks, and SOPs in accordance with cGMP standards and written procedure. • Participated in equipment start-up, commissioning, and validation activities. • Gathered, trended, and analyzed process generated data. • Created process evaluation reports, process transfer documentation, and process characterization presentations. • Assisted with training of new employees.



Embody, LLC

• Research Associate Intern

  • Aug 2017 - Dec 2017

  Norfolk, Virginia Area •Conducted an independent study on the efficacy of a novel human collagen recreation to retain stem cells. •Presented data to senior leadership, adjusted study based on feedback. •Formulated novel human collagen substitute, maintained cell lines, used scanning electron microscopy to create high quality presentations.



LifeNet Health

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Regulatory Affairs Intern

  • May 2017 - Aug 2017

  Norfolk, Virginia Area • Worked on documentation for LifeNet Health’s Hong Kong medical device renewals. • Assisted regulatory and marketing department in aligning market objectives with regulatory realities. • Created a state by state regulatory guide for interactions between local ordinances and LifeNet Health.