Clara Smith Email and Phone Number
Durham, NC, US
Clara Smith's Location
Durham, North Carolina, United States, United States
Clara Smith's Contact Details
Clara Smith work email
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Clara Smith personal email
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Clara Smith phone numbers
About Clara Smith
Clara Smith is a Senior Director, Process Development Strategy at FUJIFILM Biotechnologies. She possess expertise in protein chemistry, hplc, biotechnology, assay development, biopharmaceuticals and 18 more skills.
Clara Smith's Current Company Details
Clara Smith Work Experience Details
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Senior Director, Process Development StrategyFujifilm BiotechnologiesDurham, Nc, Us
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Senior Director, Process Development StrategyFujifilm Diosynth Biotechnologies Oct 2023 - PresentBillingham, GbMy primary role is to enable strategic workflows enabling a highly efficient and collaborative global process development organization. I am also the current Business Process Owner for the electronic laboratory notebook system globally used in the PD and PS labs. Together with other data advocates, we are mapping the future of digital strategy to enable optimal technical transfer into the company, from PD/AD to MFG/QC, and for site-to-site transfers and scale-ups. I currently participate as an active member of the DISCO (Digital Integration of Sponsor and Contract Organizations) Biophorum group. -
Senior Director, Process DevelopmentFujifilm Diosynth Biotechnologies Jul 2020 - Oct 2023Billingham, GbHead of the 160+person Process Development team at the RTP, NC site. Group included Analytical & Formulation Development, Upstream and Downstream Development, Science & Innovation, Process Characterization, Process Validation and Process Sciences for new product introductions. PD is a dynamic team tasked with bringing client processes and analytics in-house through facility fit, site optimization and scale-up, building in robustness and using risk based decision-making to enable right first time GMP manufacturing. At the RTP site, we handle cell culture (including mammalian and baculovirus) as well as microbial processes. The site also prides itself on offering advanced and comprehensive analytical capabilities, including leading edge mass spectrometry, biophysical and bioassay capabilities.
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Director, Analytical DevelopmentFujifilm Diosynth Biotechnologies Dec 2017 - Jul 2020Billingham, GbResponsible for the 60+ strong Analytical Development, Formulation Development and Methods Transfer groups at the RTP site. The groups are tasked with tech transfer/method establishment, method development, support testing for process development (full suite of biochemistry, bioassay and residual tests), manufacturing support (cell based assays, qPCR and characterization testing not performed in QC), pre-formulation and final formulation development, biophysical and mass spectrometry characterization, impurity isolation and characterization, non-GMP stability studies and method verification, qualification and validation. The group takes great pride in our ability to handle molecules from the standard mAb to extremely complex protein based therapeutics.
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Associate Director, Analytical DevelopmentFujifilm Diosynth Biotechnologies Dec 2015 - Jan 2018Billingham, GbResponsible for the operational success of the analytical development group at FDBU, including resourcing and on-time milestone delivery, with an eye towards improving efficiency, consistency and right-first-time execution within the group.
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Principal Scientist, Group LeaderFujifilm Diosynth Biotechnologies Mar 2012 - Dec 2015Billingham, GbAnalytical lead for multiple monoclonal antibody and recombinant protein programs. Responsible for analytical method development, qualification, reference characterization, impurity characterization, degradation studies, and non-GMP stability assessment. Participated in multiple efforts to improve efficiency using lean six sigma principles. Assisted with implementation of DOE-based method development using both S-Matrix Fusion AE software as well as JMP. Manager of six stellar senior level scientists.
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Associate Principal Scientist, Group LeaderFujifilm Diosynth Biotechnologies Apr 2011 - Mar 2012Billingham, GbAnalytical lead for two monoclonal antibody programs, including a biosimilar.
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Associate Principal ScientistMerck May 2010 - Apr 2011Rahway, New Jersey, UsAnalytical Lead for a biosimilar program within Merck Bioventures coordinating analytical development, characterization, comparability to originator, reference characterization, process support and assay qualification activities at sites in NC, NJ and the Netherlands. Analytical lead for a recombinant protein based vaccine being manufactured for an external client making Phase III clinical material. -
Senior ScientistDiosynth Biotechnologies, Then Schering Plough Dec 2006 - May 2010Analytical technical lead for multiple recombinant protein programs as well as a new biosimilar mAb program, which was developed in-house.
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Senior ScientistLonza Biologics Oct 2005 - Nov 2006Basel, ChScientist in the reference material characterization group. Responsible for mass spectrometry based testing including intact and reduced protein analysis, peptide mapping with post-translational modification analysis and development of rapid methodology using UPLC/MS. Also performed UV, IEF, SDS-PAGE, and other HPLC testing. Coordinated reporting of reference material qualifications. -
Scientist IDiosynth Mar 2001 - Sep 2005Performed a wide variety of testing to support multiple recombinant protein programs (HPLC, SDS-PAGE, plate-based assays, LC/MS, MALDI, UV, etc). Analytical technical lead for a high potency recombinant fusion protein which required highly sensitive analytics.
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Associate ScientistGlaxo Smith Kline Jun 1999 - Mar 2001Brentford, Middlesex, GbDeveloped analytical methods for DNA vaccines in conjunction with the biotech product development team in Beckenham, UK.
Clara Smith Skills
Protein Chemistry
Hplc
Biotechnology
Assay Development
Biopharmaceuticals
Sds Page
Analytical Chemistry
Validation
Technology Transfer
Monoclonal Antibodies
Chromatography
Mass Spectrometry
Vaccines
Gmp
Elisa
High Performance Liquid Chromatography
Proteomics
Biosimilars
Life Sciences
Lc Ms
Assay Qualification
Impurity Characterization
Uplc
Clara Smith Education Details
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Northwestern UniversityBiotechnology -
Florida State UniversityBiochemistry
Frequently Asked Questions about Clara Smith
What company does Clara Smith work for?
Clara Smith works for Fujifilm Biotechnologies
What is Clara Smith's role at the current company?
Clara Smith's current role is Senior Director, Process Development Strategy.
What is Clara Smith's email address?
Clara Smith's email address is cl****@****mdb.com
What is Clara Smith's direct phone number?
Clara Smith's direct phone number is +191955*****
What schools did Clara Smith attend?
Clara Smith attended Northwestern University, Florida State University.
What skills is Clara Smith known for?
Clara Smith has skills like Protein Chemistry, Hplc, Biotechnology, Assay Development, Biopharmaceuticals, Sds Page, Analytical Chemistry, Validation, Technology Transfer, Monoclonal Antibodies, Chromatography, Mass Spectrometry.
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