David T.

Project Manager

305 dollar
Freelancer
20 ans
Raleigh, ÉTATS-UNIS

Mon expérience

DPS Group GlobalApril 2020 - Présent

Tice Group LLCJanuary 2015 - Présent

SeqirusDecember 2019 - April 2020

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BioVectra Inc.January 2019 - December 2019

Lead Project Manager overseeing building construction, process equipment procurement, fabrication, installation, qualification and validation activities.
HVAC
ISO 7 Cleanroom
WFI
Chromatography
UF/DF
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Hyde Engineering + ConsultingJune 2018 - December 2018

Immunomedics Project
Tasked with managing Design, Procurement, Verification and turnover of $1M GE AKTA affinity and AEX column chromatography package.

Pfizer Gene Therapy Project
Tasked with managing $2M Solution Prep work package budget comprised of sterile single use equipment through Design, Procurement, Verification, and turnover.
Tasked with managing Design, Procurement, Verification and turnover of $1M GE AKTA affinity and AEX column chromatography package.
• Coordinated all efforts relating to work package including liaising with internal stakeholders, external engineering partners, and 3rd party consultants.
• Developed and implemented work package schedules, project plans and timelines to assure deliverables arrived on time.
• Managed tasking and workload of junior engineers to ensure timely completion of deliverables.
• Identified and implemented engineering changes required to achieve productivity, quality and regulatory requirements including all associated supporting documentation.
• Worked closely with manufacturing development to build technology transfer packet.
• Led PHAs and HAZOP process preparing all work packages for review process.
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Novo NordiskDecember 2015 - June 2018

Tasked with managing $10M work package budget from conception to full operational capacity including TCCC, Installation Qualification, Operation Qualification, Performance Qualification and Process Justification.
• Coordinated all efforts relating to work package including liaising with internal stakeholders, external engineering partners, and 3rd party consultants.
• Developed and implemented work package schedules, project plans and timelines to assure deliverables arrived on time.
• Managed tasking and workload of junior engineers to ensure timely completion of deliverables.
• Identified and implemented engineering changes required to achieve productivity, quality and regulatory requirements including all associated supporting documentation.
• Worked with internal business partners to build 4-year work package budget requirements including all startup, operational and maintenance costs.
• Worked closely with manufacturing development to build technology transfer packet.
• Established key contacts in overseas manufacturing plant to facilitate process knowledge transfer.
• Lead PHAs and HAZOP process preparing all work packages for review process.
• Developed and wrote interface agreements between departments and work packages including scheduling of coordinated activities.
• Provided prior engineering experience to manufacturing development to help implement centrifuge technology not previously utilized in Novo Nordisk.
activities.
• Colaborated with Process Specialists to develop capacity and scheduling model
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Ajinomoto North America, Inc.September 2012 - November 2015

Spearheaded major department improvement project formalized to reduce and eliminate product losses caused by Insoluble Foreign Matter (IFM).
Supervised all personnel associated with operation of site cleanroom environment.
Successfully led Purification in meeting the required production targets for FY 2015.
Led and supported Purification department projects through "self-assignment" or personnel assignment for all phases (design through implementation).
Ensured procedures and BPRs are updated.
Maintained the Operations Budget as listed for FY15.
Responsible for developing process improvements, and troubleshooting process issues in a cGMP environment.
• Led technology transfer and development project to introduce new amino acid product with expected annual sales of $3M at local manufacturing facility.
• Led $400k process improvement project installing a 100kl acetic acid service tank to decrease unit operation time and operator workload.
• Successfully led $100k project adding automation to cleanroom centrifugation system in effort to improve safety and reduce product loss.
• Successfully upgraded ion exchange column control software from PLC to DCS based architecture.
• Led process expansion project installing 100kL process vessel required to meet revised production goals.
• Improved crystallization process yield utilizing Six Sigma experimental methodology resulting in $100K of increased productivity.
• Identified and implemented process limits on crude material quality as part of a CAPA investigation preventing future product and monetary losses valued at over $100K/annually.
• Successfully designed and installed sterile process equipment for shock-seeding a 30KL evaporator.
• Handpicked to join team investigating product failure at customer’s overseas manufacturing facility.
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BASFJanuary 2012 - September 2012

Tasked with performing product formulation studies in support of process group
Performed process development studies for new product formulations.
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American Crystal Sugar CompanyJanuary 2011 - August 2011

Responsible for the identification, design, and implementation of process upgrades to capital equipment.
• Saved $125K annually through the reduction of steam demand in a multistage evaporator system.
• Increased energy savings and environmental compliance through the reduction of biogas vented
to atmosphere.
• Recovered 8M lbs. of lost product using ad hoc processing strategy developed in house.
• Successfully managed the installation of process equipment valued at over $700K.

Boulder Scientific CompanyJanuary 2007 - January 2010

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United States Air ForceJanuary 2000 - December 2006

Managed daily operations of 40-person intelligence collection section.
• Successfully brought a newly developed intelligence collection system up to full operational readiness.
• Wrote custom Microsoft Excel Macro to reduce analysts processing and reporting times.
• Increased output by optimizing processing parameter database, effectively doubling the number of daily processed data sets from 500K to over 1M.
• Tripled analyst productivity and competency through redesign of analyst training procedures.

Mes compétences

Computer Tools

MS Office

CAD&CAM

AutoCAD, Autodesk Inventor

Languages

C/C++, Swift

Others

Spanish, Six Sigma, Management, Leadership, HPLC, GMP, Design, Troubleshooting

Mes études et formations

Master of Engineering - MEng, Engineering/Industrial Management - University of North Carolina at Charlotte2016 - 2018

Masters Degree, Biomedical/Medical Engineering - Colorado State University2014 - 2016

Chemical Engineering - The University of North Dakota2010 - 2012

Bachelor of Science, Chemistry/Biology - Metropolitan State University of Denver2004 - 2006

Bachelor of Applied Science (B.A.Sc.), Intelligence Analysis - College of the Air Force2000 - 2003