Scott Compton Email & Phone Number

Chapel Hill, Nc, Us

Chapel Hill, Nc, Us

Billingham, Gb

• Lead design and development of purification process equipment and facilities for a new >$3.3 billion large-scale, greenfield manufacturing site for biopharmaceuticals. This will be the largest end-to end cell culture CDMO provider in North America.• Lead the purification process equipment team throughout the project being the main contact to the EPCM provider to develop P&IDs, URSs and other process documents. • Lead FAT, CQV, Commissioning, & start-up activities and ensure on time delivery and in right quality from both Fujifilm and EPCM provider

New York, New York, Us

- Equipment design & procurement for Gene Therapy (GTx) purification (downstream) suite- GMP Process design and tech transfer of GTX process from lab and pilot scale to commercial manufacturing- Author process and equipment descriptions, process flow diagrams and risks assessments- Identify potential process improvements and lead change management & implementation for changes to the manufacturing processes and associated systems - Design technical and engineering studies, writes technical summary reports, and generates necessary data to support change impact assessments during process transfers and investigations- Provide lead technical support for the development and modifications of operational process and equipment documentation including SOP, Job aid and Master batch records- Lead GTx process monitoring and verification activities- Lead production support during processing operations- Organized and led the completion of commissioning and qualification of downstream equipment and unit operations- Assisted in the creation of Emerson DeltaV automation recipes to monitor & control mfg equipment - Assisted Operations as the technical SME in the development of site documentation including SOPs, master batch records, on the floor job aids, equipment PMs and LOTO

Basel, Baselstadt, Ch

- Led new process design, process proof of concept through characterization studies in alignment with program strategy, pre-clinical materials generation, direct clinical and commercial GMP operations support, scale-up studies scale model demonstration through qualification, raw materials and process pool evaluations in addition to process optimization and improvement studies.- Planned, executed and documented experimental procedures and complex studies in support of process development activities supporting investigational, clinical and commercial gene therapy programs.- Advanced complex downstream process development efforts as a technical lead within a cross-functional team across Novartis Gene Therapies sites.- Led projects within the downstream unit to enhance manufacturing AAV purification technologies, capabilities, and processes.- Supported active pre-clinical, clinical and commercial manufacturing through laboratory studies designed to illuminate fundamental process performance (e.g. NOR and PAR setting, CPP edge of failure, impurity clearance performance).- Authored technical reports in support of process development activities such as Tech Transfer, unit operation design through characterization and Quality attribute impact assessments.- Led and mentored junior colleagues while fostering a team environment committed to the principles of scientific excellence.- Provided support to other scientific and engineering staff as a technical SME for all purification steps including cell lysis, depth filtration, chromatography and tangential flow filtration.

Basel, Baselstadt, Ch

- Executed cGMP batches to generate clinical and commercial Zolgensma material- Led Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for large scale manufacturing equipment including adherent cell single use bioreactors, chromatography skids and Tangential Flow Filtration (TFF) skids- Led the design and start up of the manufacturing training facility and process development lab- Trained colleagues on gene therapy manufacturing operations

New York, New York, Us

- Tech transfer of Hemophilia B and Duchenne's Muscular Dystrophy Gene Therapy processes from lab and/or pilot scale to commercial GMP- Single use and stainless steel process design for GMP GTx manufacturing suites - Equipment design & procurement for downstream suites including lysis, filtration, chromatography and ultrafiltration skids - Led FAT and SAT for downstream equipment including microfluidizer/high pressure homogenizer, single use and stainless steel UFDF systems, AKTA process chromatography skids, manual and automated chromatography columns, single use mixers, viral filtration skids, peristaltic pumps, biological safety cabinets, fridges and freezers- Organized and led the completion of commissioning and qualification activities- Led the design and execution of downstream engineering runs- Assisted in the creation of automation recipes to monitor & control manufacturing equipment via Emerson DeltaV - Managed and led Operations in the development of site documentation including SOPs, master batch records, on the floor job aids, equipment PMs and LOTO

New York, New York, Us

Third Rotation - R3 Formulation Process Engineering (Jan 2017 - Apr 2017)- Performed factory acceptance testing, installation, shake-downs and site acceptance testing of R3 formulation equipment- Assisted in the commissioning of R3 equipment by writing commissioning documentation and executing commissioning requirements- Developed, wrote and executed protocols for cleaning, gassing and formulation process development requirements- Assisted in the execution of the IQ/OQ requirements for R3 equipment- Wrote and submitted specifications for new commodities and disposablesSecond Rotation - Global Technical Services (July 2016 - Dec 2016)- Created and managed project plans for the development and validation of new products for the VisIV business unit at the RM site. - VisIV expansion project work included creating and performing engineering studies to develop equipment parameters for new IV bag configurations, fabricating and executing feasibility studies to manufacture new products in polypropylene IV bags and travel to other Pfizer sites to support project completion.- Led an alternative tubing project focused on improving final product concentration and reducing impurities during small vial and ampule product manufacturing.- Supported Pfizer global R&D projects by working with EH&S and engineering from multiple sites in order to plan the launch of new products coming out of the Pfizer product pipeline.First rotation - Quality Operations (Jan 2016 - June 2016)- Focused around the implementation of Pfizer systems to Legacy-Hospira, Rocky Mount, following the Q4 2015 acquisition and included site projects associated with quality systems, process improvements, cGMP compliance, and remediation.- Responsible for leading and coordinating change control processes, updating and developing SOPs, defining site specific data input, determining personnel roles in the security matrix and designing a universal product tester.

Raleigh, North Carolina, Us

- Research involved growing, purifying and analyzing cell cultures- Lab techniques included qPCR, gel electrophoresis, HPLC, UPLC, gel-filtration, centrifugation, western blotting and normal flow filtration- Research efforts were aimed at the interface between biology and engineering to understand the bioenergetics, biochemistry, physiology and genomics of extreme thermophiles- Studies gave rise to a number of developments related to bioenergy, biofuels, recovery of base, precious and strategic metals from ores, and industrial biocatalysis

Raleigh, North Carolina, Us

Teaching Assistant for Introduction to Chemical Engineering Analysis and Thermodynamics of Chemical and Phase Equilibria.

Us

Master Of Science - Ms, Chemical Engineering

Bachelor Of Science (B.S.), Chemical & Biomolecular Engineering And Biotechnology Minor