Amy Pierce Email & Phone Number

Warwick, RI, US

Hampton, NJ, US

Waltham, Massachusetts, US

• Led fed-batch mammalian cell culture development studies for top monoclonal antibody (mAb) candidates in CHOZN cell line at bench scale (shake flasks – 15 L glass bioreactors)
• Led scale-up activities, including oxygen transfer & agitation studies, to transfer CHO cell culture process from 3 L to 15 L bioreactors for toxicology material generation to support regulatory filings
• Authored & revised critical documentation, including technical reports, presentations, & SOPs
• Developed & implemented digital project management tools to help plan experiments & analyze data, including efficient data templates using Microsoft Visual Basic, team schedules, inventory/procurement, etc.
• Assisted Chief Technical Officer by managing monthly chemistry, manufacturing & controls (CMC) department meeting agendas, minutes, & timelines
• Communicated with vendors to obtain quotes and acted as procurement point person for upstream team

Novato, California, US

• Led experiments to optimize & characterize bench scale (AMBR15, shake flasks, 2 – 10 L single-use bioreactors) fed-batch & perfusion mammalian cell culture production processes for early-stage platform recombinant.
• Led cell banking & thaw studies to evaluate manufacturing deviations to develop robust procedures
• Contributed to platform improvement & process and analytical technology (PAT) implementation including feed media development, process intensification, & instrument bridging
• Generated & analyzed critical data to support regulatory filings through electronic notebook (ELN) management, technical reports, batch records, presentations, & SOPs
• Represented upstream team as safety officer in EH&S meetings as process subject matter expert (SME) & led working team to implement 5S & lean practices in the lab
• Collaborated with internal functions & external groups such as contract development & manufacturing organizations (CDMOs) to discuss key deliverables and process changes

Paris, France, FR

• Supported life-cycle management & commercial-scale tech transfer of mammalian cell culture (CHO) manufacturing processes for monoclonal antibody (mAb) & recombinant enzyme production
• Assisted with bench (2 L glass bioreactors) & pilot scale (50 – 500 L single-use bioreactors) fed-batch & perfusion cell culture batches, from thaw to harvest, including large scale (>3000 L) media & solution prep
• Worked with external vendors in design & procurement of equipment, instrumentation & materials
• Represented pilot team on department 5S working team

Cambridge, MA, US

• Operated preparative ion exchange (IEX) chromatography skids & performed solid phase extraction (SPE) for bench scale, high-throughput oligonucleotide purification
• Led parts inventory management & lab equipment preventive maintenance schedule

Woburn, Massachusetts, US

• Set up pilot scale (5 – 12 L) glass continuous stirred-tank (CSTR) crystallization vessels & analyzed samples for moisture content (via Karl Fischer titration) & refractive index
• Organized quality documentation & implemented quality practices within lab
• Supported engineering run to test robustness & stability of pilot scale integrated continuous manufacturing (ICM) skid for small molecule pharmaceuticals

Boston, MA, US

• Developed method using isoelectric focusing (IEF) & SDS-PAGE to identify post-translation modifications (PTMs) of novel proteins using charged non-canonical chemical moieties

• Designed, conducted, & analyzed bench scale (1 – 10 mL) optimization design of experiment (DOE) studies for synthetic routes to produce novel deuterated APIs
• Kept organized electronic notebook (ELN) for data analysis, report writing, & cross-functional use

Boston, MA, US

• Prepared visible light cross-linking gelatin-methacryloyl (gelMA) hydrogel samples for testing to determine biomechanical properties for applications as cardiac tissue sutures

New York, New York, US

• Developed & analyzed mixing time & oxygen mass transfer design of experiments (DOE) studies for pilot scale (100 – 1000 L single-use bioreactors) fed-batch mammalian cell culture (CHO) processes
• Supported daily operations, including bioreactor sampling and setup/take down

Paris, France, FR

• Redesigned energy usage & cost-reduction project management workbook using Microsoft Visual Basic to track past & future projects over six sites
• Oversaw implementation of 2016 energy projects at Allston, MA facility, including ISO 50001 certification, steam disconnection risk assessment, & cogeneration plant heat mapping analysis
• Acted as EH&S and facilities department liaison between Allston & Framingham sites

Master Of Science - Ms, Bioengineering

Bachelor Of Science - Bs, Chemical Engineering