-Managed 5 direct reports consisting of junior and mid level engineers. Provided career guidance, project management, and positive working environment for a high performing team.-CMC co-lead responsible for definition of manufacturing, development and regulatory strategies for early stage CAR-T product (P-MUC1C-ALLO1).-Responsible for defining and executing comparability studies for implementation of a phase 2 viable process for lead allogeneic CAR T product (P-BCMA-ALLO1).-Designed and implemented process changes in internal pilot plant to significantly improve product purity and decrease process time by 50% for a magnetic cell separation process intended to remove TCRab+ species from drug substance. Presented this work at external conference.-Led development team in generation of proof-of-concept data for T cell expansion in stirred tank bioreactors.-Responsible for manufacturing support including leading technical risk assessments, deviation assessments, process FMEA, OOS investigations, statistical process control, raw material trending and designing process development studies to support MFG investigations-Responsible for development of tech transfer documentation for partner (Roche) including process descriptions, process flow diagrams, sampling plans, BOM, etc.-Led efforts to increase PD capabilities by organizing DOE training with external vendor

-Group leader for downstream and conjugation technical operations team of four junior and mid-level scientists-Lead SME for process characterization data analysis and development of control strategy for mAb:dye conjugate process using QBD principles which was implemented for successful PPQ campaign at external CMO and accepted for commercially approved product-Led team which successfully completed mAb intermediate, conjugation, drug product process development and tech transfer for a mAb:dye conjugate for IND enabling clinical manufacturing process at external CMO-CMC SME and author for IND and BLA submission packages for multiple pipeline products, including one commercially approved product. Authored responses to regulatory agency queries-Led efforts for CMO due diligence through quality audits, technical discussions, initiation of RFPs for pipeline projects-Coordinated support for research material generation of various mAbs, Fc fusions, fragments, cytokines for translational sciences group

-Led efforts to identify gaps in downstream development capabilities and build justification for capital purchases to improve company capabilities-Increased capabilities for in house production of PEGylayed cytokines using a proprietary strain of E Coli from sub 1 mg research scale to >1 g scale using scalable manufacturing processes-Assist with technical transfer of complex downstream process for multiple cytokine products (pre-clinical and clinical stages)-Developed analytical assays (RP, SEC) for monitoring product titer and protein refolding for various cytokines

-Developed late stage development strategy for Gilead biologics. Developed best practices for risk analysis, process characterization, impurity challenge and spiking studies, and column lifetime studies. Successfully executed PPQ campaign for late stage mAb at a 12kL commercial manufacturing site. Presented the strategy at the 2017 Bioprocessing Summit in Boston, MA.-Characterized and implemented process changes to mitigate induced aggregation which was observed for a number of in house mAbs with common Fc modifications. Developed screening analytics and methodology to identify and minimize instances of induced aggregation.-Assisted with molecular assessment of a research stage mAb. Identified two lead constructs which were recommended for RFD.-Skilled in laboratory automation using Tecan and Hamilton liquid handling robots. Developed user friendly scripts for sample handling, aliquoting, protein A material generation, chromatography operating condition screening and buffer preparation.-Was part of a team that developed a biologics extractable and leachable strategy which was adopted throughout the company.

-SME for virus clearance activities. Led the design and execution of late stage four panel virus clearance studies.-Performed tech transfer to multiple facilities including 100L pilot plant, 2kL clinical manufacturing and 12kL commercial manufacturing scales. Provided PIP support at all sites. Authored process development deviation assessments.-Quickly redeveloped a mAb process after an immunogenic host cell protein was discovered. Identified an acceptable third step mixed mode chromatography resin using high throughput resin screening. Transferred the process for a successful late phase clinical manufacturing campaign in less than 2 months.-Developed a HIC purification method to purify a host cell protein which was successfully used for immunization of animals and generation of an HCP specific ELISA assay. Assisted with the development of a RP assay to assess the purity of the HCP.-Highly skilled in operation of analytical HPLC instruments and troubleshooting various assays (IEC, SEC, RP, fluorometry). Developed and implemented fluorescence based assays (HPLC and fluorometer based) used to assess product carryover in column lifetime studies. Skilled at developing instrument and data processing methods in Chromeleon and Empower.

Part of a team of four that developed, scaled up and tech transferred protein purification processes to an in house clinical manufacturing team for MAbs and other recombinant proteins.-Successfully assisted with the transfer of a production process for a recombinant protein by E Coli from an outside contractor. Optimized cell harvest, IB washing, solubiliztion, refolding and two chromatography operations.-Scaled up a lab scale monoclonal antibody production process to a pilot scale single use manufacturing line and generated toxicology material that met all product quality requirements. Assisted with tech transfer by authoring PFDs and batch records. Provided process training for manufacturing technicians.-Designed and performed lab scale harvest study to identify the root cause of reduction issues observed in clinical manufacturing. Identified process equipment deficiencies and recommended changes that were implemented by manufacturing.-Transferred scaled down viral filtration processes for multiple products to a contract virology lab for viral clearance work.-Performed early developement work for a three column monoclonal antibody process. Focused on developing a polishing step to separate charged isoforms and achieve target charge profile. Performed high throughput resin screening using automated lab equipment (Tecan).-Demonstrated strong leadership ability by taking on a CMC team role for two products being developed for early phase clinical trials. Was responsible for managing timelines, maintaining open communication between functional groups and running project team meetings. Mentored interns and junior manufacturing technicians.-Maintained positive relationship with industry vendors. Performed individual research to stay up to date with current technology. Assisted with IP review.

Process engineer responsible for providing engineering technical support for a pilot scale clinical manufacturing process as well as performing PD on a variety of processes:-Authored OOT, OOS, CAPA, change control and deviation reports.-Optimized viral and sterile filtration processes using Vmax and Pmax-Selected vendors, scaled up and characterized TFF processes (micro and ultra filtration, cassette and hollow fiber) from the lab to pilot scale.-Researched all ASTM, FDA and EU regulations for integrity testing of flexible IV bags. Optimized and characterized a flexible bag integrity test. -Optimized a validated solvent detergent viral inactivation step to reduce process variability.-Generated operational design spaces for different chemical mixing processes.-Investigated the use of citric acid in place of phosphoric acid as a process cleaning agent. Generated residual citric acid rinse water specifications.-Experienced in creating drawings for stainless steel fabrications.-Created statistical process control charts to track in process and final product testing results. These charts were used by upper management to monitor process stability and initiate investigations when necessary. -Worked on tech transfer to a commercial facility. Experience writing process descriptions and providing facility size estimates. -Extensive experience writing technical reports, protocols, memos and maintaining a lab notebook. Knowledge of cGMP, cGEP, cGLP and cGDP.

Technician for hemoglobin based oxygen therapeutic drug production process going through clinical trials. Qualified aseptic fill operator in ISO5 environment.

-While a year-round, full time student, worked for a top 10 global biopharmaceutical company. Selected from a group of competitive college students.-Became knowledgeable with equipment and lab techniques used for the high-throughput protein crystallization process. -Maintained lab according to standards needed for important drug discoveries. Used proprietary equipment, such as complex automated laboratory systems designed to increase the productivity of the company.-Used knowledge gained to assist the various scientists at the company design experiments that could be performed by the equipment on hand.