Senior Scientist/ Technical Leader Resume Example

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.

• 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 Phelps.
• 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 Phelps, 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.

• 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)