Experience

Boston Institute of Biotechnology, LLC

• United States
• Biotechnology Research
• 1 - 100 Employee

• Director Of Manufacturing

  • Jan 2019 - Present

  Direct technology transfer, scale-up and production to ensure successful mammalian and microbial GMP manufacturing in compliant with regional and international regulatory requirements. Spearhead AAV viral vector design, process development and production. Direct technology transfer, scale-up and production to ensure successful mammalian and microbial GMP manufacturing in compliant with regional and international regulatory requirements. Spearhead AAV viral vector design, process development and production.



Selecta Biosciences

• Watertwon, Massachusetts

• Senior Process Development Engineer

  • Jun 2016 - Jan 2019

  Managed drug substance and drug product production for use in clinical trials and scaling production for the commercial market. Oversaw technical activities of CDMOs (China and US sites) performing biologics process development and manufacturing activities. Led drug substance supply chain in the CMC team and participated in IND submission. Collaborated with internal/external QA and QC ensuring all CMOs and processes were compliant with the applicable requirements and regulations. Managed drug substance and drug product production for use in clinical trials and scaling production for the commercial market. Oversaw technical activities of CDMOs (China and US sites) performing biologics process development and manufacturing activities. Led drug substance supply chain in the CMC team and participated in IND submission. Collaborated with internal/external QA and QC ensuring all CMOs and processes were compliant with the applicable requirements and regulations.



GreenLight Biosciences

• United States
• Biotechnology
• 100 - 200 Employee

• Senior Process Development Engineer

  • May 2014 - Jun 2016

  Served as the industrialization lead responsible for design and implementing bioreactor experiments and scalable control strategies for optimization for both cell growth and bio-production. Managed tech transfer and the manufacturing activities at CDMO sites. Served as the industrialization lead responsible for design and implementing bioreactor experiments and scalable control strategies for optimization for both cell growth and bio-production. Managed tech transfer and the manufacturing activities at CDMO sites.



FUJIFILM Diosynth Biotechnologies

• United Kingdom
• Biotechnology Research
• 700 & Above Employee

• Associate Principal Scientist

  • Dec 2013 - May 2014

  Led upstream cell culture and fermentation process including technology transfer, scale-up and process optimization. Led upstream cell culture and fermentation process including technology transfer, scale-up and process optimization.



Lonza

• Switzerland
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Senior Scientist

  • Mar 2010 - Sep 2013

  Managed and executed microbial fermentation and primary recovery development, including separation, homogenization, clarification, and Tangential Flow Filtration (TFF). • Established fermentation lab to support Risk Group 2 microbial culture. • Led technology transfers from customer site through R&D to cGMP manufacturing. • Managed technical team to demonstrate and optimize fermentation process from bench scale to pilot scale to manufacturing scale. • Employed Design of… Show more Managed and executed microbial fermentation and primary recovery development, including separation, homogenization, clarification, and Tangential Flow Filtration (TFF). • Established fermentation lab to support Risk Group 2 microbial culture. • Led technology transfers from customer site through R&D to cGMP manufacturing. • Managed technical team to demonstrate and optimize fermentation process from bench scale to pilot scale to manufacturing scale. • Employed Design of Experiments (DOE) to characterize upstream fermentation processes. • Prepared and reviewed process development protocol, technical batch records, SOPs, and reports. • Presented data to customer. • Supported cGMP campaigns (training, documentation, problem solving, technical expertise).

• Scientist

  • Sep 2007 - Mar 2010

  - Project/Technical Leader -- Upstream Fermentation Process.



SelectX Pharmaceuticals Inc

• Senior Staff Scientist

  • 2002 - 2007

  Directed all activities within microbial fermentation team; led culturing, processing, and maintenance of clonal libraries in support of drug discovery. • Developed diverse library selection through execution of screening and assay strategies for antibacterial and chemotype compounds. • Performed gene cloning to support core platforms and new drug targets, such as cloning antibiotic biosynthetic genes and gene encoding aminoglycoside-modifying enzymes. • Designed growth media… Show more Directed all activities within microbial fermentation team; led culturing, processing, and maintenance of clonal libraries in support of drug discovery. • Developed diverse library selection through execution of screening and assay strategies for antibacterial and chemotype compounds. • Performed gene cloning to support core platforms and new drug targets, such as cloning antibiotic biosynthetic genes and gene encoding aminoglycoside-modifying enzymes. • Designed growth media and optimized growth conditions for broad and specific chemotype production in agar plates, tubes, flasks, and bioreactors. • Collaborated on multidisciplinary teams, i.e. genetics, chemistry, and screening groups, to meet corporate objectives. Show less Directed all activities within microbial fermentation team; led culturing, processing, and maintenance of clonal libraries in support of drug discovery. • Developed diverse library selection through execution of screening and assay strategies for antibacterial and chemotype compounds. • Performed gene cloning to support core platforms and new drug targets, such as cloning antibiotic biosynthetic genes and gene encoding aminoglycoside-modifying enzymes. • Designed growth media… Show more Directed all activities within microbial fermentation team; led culturing, processing, and maintenance of clonal libraries in support of drug discovery. • Developed diverse library selection through execution of screening and assay strategies for antibacterial and chemotype compounds. • Performed gene cloning to support core platforms and new drug targets, such as cloning antibiotic biosynthetic genes and gene encoding aminoglycoside-modifying enzymes. • Designed growth media and optimized growth conditions for broad and specific chemotype production in agar plates, tubes, flasks, and bioreactors. • Collaborated on multidisciplinary teams, i.e. genetics, chemistry, and screening groups, to meet corporate objectives. Show less



Omni Science Pharmaceuticals, Inc.

• Staff Scientist

  • Sep 2000 - Sep 2002

  Developed DNA libraries for drug discovery, isolated DNA from soil samples, and generated DNA libraries in E.coli and Streptomyces. • Created environmental DNA libraries to support the company’s new drug screening platforms. • Successfully cloned streptomycin biosynthetic gene and expressed gene heterologously in Streptomyces. Developed DNA libraries for drug discovery, isolated DNA from soil samples, and generated DNA libraries in E.coli and Streptomyces. • Created environmental DNA libraries to support the company’s new drug screening platforms. • Successfully cloned streptomycin biosynthetic gene and expressed gene heterologously in Streptomyces.