Montgomery Street, San Francisco, CA94105(555) 432-1000, resumesample@example.com
Professional Summary
Highly-skilled Technical Lead adept at project management, leadership of matrix teams for corrective action preventive action (CAPA) investigations and developing innovative technical solutions for upstream/downstream processes. Excellent communication and negotiation skills with a solid record of managing highly effective teams to execute complex projects within tight timeframes. Oversees technical transfer scale- up, verification and validation for cGMP manufacture of mammalian cell culture media. Successful at leading both internal and external teams to accomplish challenging objectives.
Skills
A+ 3
Academic
Acrylic
C+ 2
Oral
Competitive
Contract negotiations
Executive management
Filing
Grants
Materials
Presentations
Strategy
Work History
01/2013 to CurrentSenior Scientist/ Technical LeaderThermo Fisher Scientific Inc. | Washington, DC,
Technical lead for successful New Product Introduction (NPI) launches for Efficient Feed A+ 3X, Efficient Feed B+ 3X and Efficient Feed C+ 2X concentrates in 10L Aegis bags.
Authored documents required to hit critical stage gates on time to support commercialization of new products.
Created highly visual technical presentations to summarize project status, issues and risks for project stakeholders and executive management.
Participated in contract negotiations to ensure agreements were in place with CRO partners, academic institutions and external companies to define project deliverables and payment terms.
Principal Investigator for evaluation of new technologies and management of external partnerships (3 Competitive Grants Awarded, see Competitive Grants Awarded section).
Drafted patents with patent agent to develop worldwide filing strategy for patent applications (5 Patents Filed, see Awards/Patents/Presentations section).
01/2010 to 01/2013Staff ScientistBristol Myers Squibb | Cambridge Park, MA,
Led scale-up project, implemented a simplified formulation process for a key raw material; this action resulted in increased production capacity (3X), 50% reduction in production frequency, year over year revenue growth
(~8 %) and increased margins (~4 %) for B-27 Supplement 50X.
Developed effective corrective action/ preventive action (CAPA) for a formulation process change that resulted in ~83 % reduction of customer complaints for Dulbecco’s Phosphate Buffered Saline (DPBS).
Identified raw material as root cause of performance failure, contributed to new assay development, enabled site to clear ~$300k in customer backorders for Freestyle 293 medium.
Identified root cause of raw material (riboflavin) performance failure.
Designed and implemented alternative process for AGT (Advanced Granulation Technology product format) production using riboflavin.
These actions resulted in ~$45M in revenue protection across AGT product platform and provided an alternative to being limited to a single source supplier for riboflavin.
Core team member of Materials Review Board, led raw material related CAPA investigations, supported qualification of raw material vendors and vendor site audits.
01/2008 to 01/2010Division ChemistDUPONT BUILDING INNOVATIONS | City, STATE,
Delivered experimental data, forecasted long-term performance to support warranty claims for new product launched mid-2010.
Polymer composite formulation with emphasis on structure/property relations.
Developed method for incorporation of renewable polymers in filled acrylic composite.
01/2005 to 01/2008Principal ScientistGLAXOSMITHKLINE | City, STATE,
Generated & interpreted physical/chemical analytical data to support pre-formulation strategies for pharmaceutical development & reported key data/findings to program teams.
Co-authored regulatory documents in support of lead drug candidates progression from discovery medicine to pre-clinical development.
Collaborated with scientists from pharmacokinetics group to develop (3) formulations for oral and intravenous administration.
Education
Expected in 2005Ph.D | ChemistryPennsylvania State University, , GPA:
Expected in 2002M.A | ChemistryState University of New York College, Buffalo, GPA:
Expected in 1997B.S | ChemistryState University of New York, Buffalo, GPA:
Accomplishments
A Novel Time Release Feed Media Format - Collaborative Research Compact award (CRC) to evaluate a new inorganic Controlled Release Technology (iCRT) as a collaboration with U.K.
Based materials science company Lucideon Ltd.
Co-principal investigators: Dr.
Phil Jackson and Dr.
Gilda Gasparini (CRC seed grant $50k) (2017)
Next Generation Advanced Granulation Technology (AGT) Media Format - Collaborative Research Compact award (CRC) to adapt fluid bed pelletization CPSTM technology (Glatt Air Techniques) to produce to cell culture media pellets, collaboration (CRC seed grant $50k) see Patent filing below.
(2015)
Electrochemical Method for Virus Inactivation and Removal in BioProdution- Collaborative Research Compact award (CRC) to evaluate a new Electrochemical Carbon Nanotube Filter for inactivation and removal of adventitious agents, collaboration with Harvard University Engineering Group co-principal investigator: Prof.
Chad Vecitis (CRC seed grant $50k) (2014)
PROVISIONAL PATENTS
Cell Culture Media Tablets and Methods of Manufacture.
Inventors: Mwita Claire.
US Appl.
62/902,703 /LT01487 PRO.
(2019)
NON-PROVISIONAL PATENTS FILED
Streamlined Methods for Making Liquid Media, Inventors: Neva Alles, Deirdre Eychner, Gabrielle Lorenzo, Mary Reynolds, Paul Gulde, Ryan Boniface, Mwita Claire, Mathew Kahn, Richard Fike.
International Appl.
PCT/US2018, Scanning Electron Microscopy (SEM), X-ray Powder diffraction (XRPD), multi-Nuclear Magnetic Spectroscopy (NMR), Infrared (IR) and UV-visible spectroscopy, Differential Scanning Calorimetry (DSC), Thermo Gravimetric Analysis (TGA), (GC) Gel Permeation Chromatography (GPC), Size Exclusion Chromatography (SEC),High Pressure Liquid Chromatography (HPLC), Gas Chromatography (GC), Flow cytometry, Bio HT, small scale bioreactor, Vi cell.
Project management experience– Excellent communication and negotiation skills, Management of all project deliverables including agreements, timelines, budgets, project scope and reports related to contract research organization (CRO) partnerships.
Team leadership experience: Leadership of matrix teams for corrective action preventive action (CAPA) investigations, Supervised technicians during scale-up projects that resulted in significant revenue increases and improved product quality of mammalian cell culture media (see Manufacturing Sciences section).
Product development experience-Technical lead for New Product Introductions (NPI) for key milestone activities: formulation, stability studies, technology transfer, verification and validation for cGMP manufacture of cell culture media for monoclonal antibody (mAb) and vaccine production (see Senior Scientist section),.
Layered Advanced Granulation Technology (AGT) media format -Managed a small team of scientists to successfully develop fluid bed layering/coating of granulated cell culture media for improved stability and modified release applications for production of biotherapeutics: monoclonal antibodies, vaccines (see Patent filing below).
A Novel Time Release Feed Media Format – Managed external collaboration to evaluate inorganic Controlled Release Technology (iCRT) for use in BioProduction (see Competitive Research Grants and Presentations sections below).
Leadership in upstream/downstream processes - Managed academic collaboration (Harvard) to develop Electrochemical Method for Virus Inactivation and Removal in BioProdution, Subject Matter Expert Upstream/Downstream process development at MIT Consortium on Adventitious Agent Contamination in Biomanufacturing, (see Presentations below) In-depth knowledge of chemical principles involved in formulation of chemically defined media and cellular metabolism for gene therapy (AAV production), cell therapy (T-cells) and monoclonal antibodies (mAb , experienced in resin chemistry, viral inactivation methods, filtration techniques, small scale bioreactor (Ambr), high throughput liquid handling device (SimCell), design of experiment (DoE), Minitab.
Additional Information
AWARDS/PATENTS/PRESENTATIONS
AWARDS
, My Idea “Open Ideas” Implementation award for Dry Format Nutrient Supplementation: Merging Single Use Capabilities with AGT Product Line Extension (2018)
Research & Development Innovation Award –Thermo Fisher Scientific, Life Sciences Solutions division (2016)
Research & Development Innovation Award–Thermo Fisher Scientific, Life Sciences Solutions division (2014)
Top Talent Award – Identified as showing high potential for Innovation and Leadership –Life Technologies Manufacturing Sciences division (2013)
Bronze Award – Team achievement for root cause analysis OpTimizer Life Technologies Manufacturing Sciences division (2013)
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