Summary
Overview
Work History
Education
Skills
Websites
Certification
Selectedskills
Publications
Timeline
Generic

DANIEL L. MORRIS

Kirkland,WA

Summary

Motivated people-oriented team leader successful in monitoring performance, delegating work and motivating members. Versed in managing daily direction and team communication. Collaborative and resourceful professional dedicated to identifying needs to develop and deliver creative solutions.

Overview

30
30
years of professional experience
1
1
Certification

Work History

QC Team Lead: Global Stability, Outsourced Testing and LIMS Administrator

Inventprise, Inc.
02.2021 - Current
  • Ground-level creation and maintenance of the Global Stability program for Inventprise, Inc., for all bacterial and viral vaccines following cGMP (following FDA, WHO and ICH guidance) focused on equipment and processes for future expansion to meet the growing Inventprise pipeline
  • Team Lead for data review and trending of stability results, biochemistry, biophysical analytics and outsourced testing for safety and potency
  • Supervision of QC Lab Technicians in charge of maintenance, ordering and facilitating QA release of QC chemicals and consumables, shipping and data archiving of outside testing results
  • HazMat: Biohazard, expired chemicals and hazardous liquid waste management for all Inventprise sites (F1, F3 and F4)

Property Manager and Remodeling Contractor

LAM Properties
Lake Stevens, USA
01.2014 - Current
  • Property management, remodeling, maintenance, and cleaning of rental properties

Dept Supervisor/Sales Associate

The Home Depot
04.2017 - 02.2021
  • Sales Associate and Department Supervisor at Stores 4713, 4745 and 4726
  • Electrical, Plumbing and Kitchen & Bath, Lumber and Building Materials, Hardware, Garden and Order Fulfillment
  • Overall, 12-time Homer Award Winner (Platinum level), 8-time Employee of the Month
  • Outstanding Customer Service, Safety and Creating Shareholder Value

QA Associate III

CMC Biologics (Contractor through Com-Force)
Bothell, USA
05.2016 - 12.2016
  • Group Leader on various QA activities for lot disposition and release
  • Utilized prior skills and experience to facilitate Drug Substance disposition
  • Master batch record, QC data review and LIRs, deviation investigation and CAPA support
  • Worked in cross-functional groups as a SME to drive compliance deadlines
  • Highlight – Determined lot disposition for 20 overdue batches in a few months, received CMC TEAM Award for my contributions, while under contract

Sales Associate

Home Depot
Everett, USA
03.2016 - 06.2016
  • Sales Associate in Lumber/Building Materials, Electrical and Plumbing

Sales Associate

Lowe’s Home Improvement
Everett, USA
02.2015 - 03.2016
  • Sales Associate; Electrical and Plumbing/Kitchen and Bath departments
  • Lowe’s Certificate of Awesomeness and Employee of the Month winner

Sales Associate

Home Depot
Bellevue, USA
08.2013 - 12.2014
  • Sales Associate in Plumbing, Hardware, Lumber/Building Materials and Garden departments
  • 4-time Homer Award for outstanding customer service

Senior Scientist

Amgen (Contractor through Lancaster Labs, Inc.)
Seattle, USA
05.2012 - 10.2012
  • Performed cGLP ELISA assays on drug substance process development for host cell proteins and rProA residuals
  • TECAN robotics, assay validation and improvement, statistical analysis and report writing

Associate Scientist

Amgen (Contractor through Aerotek Scientific)
Seattle, USA
01.2011 - 06.2011
  • Pre-commercial drug substance and drug product research, simulated transportation and stability studies under cGMP, biophysical characterization of drug substance and drug product test articles

Senior Research Associate II, Biology

Gilead Sciences, Inc.
Seattle, USA
03.2008 - 10.2010
  • Bioassay development, drug/target interaction, protein biochemistry (SDS-PAGE and Western blotting), ligand binding and enzyme kinetics
  • Bioassay development to support SAR on small-molecule inhibitors of mucin production for COPD
  • Bead-based assays by Quantigene and qRT-PCR for mucin and MMP gene expression and Luminex for cytokine and chemokine modulation
  • Highlight – Brought siRNA gene silencing as a research tool to Gilead Sciences

Research Associate IV

Nastech Pharmaceutical Company, Inc.
Bothell, USA
10.2003 - 11.2007
  • Protein purification and characterization, GLP preclinical and cGMP clinical supply manufacture
  • Process development, drug substance and product development, scale-up and process validation
  • Peptide hormone formulation sciences (stability, dissolution, formulation optimization, permeation and cytotoxicity)
  • Particle sizing, Peptide/siRNA biophysics (CD, DLS and calorimetry), microscopy of excipient effect on tight junction complexes and siRNA-peptide microparticle formation (TEM and Confocal) and bioassay development and optimization
  • FDA submission on biophysical characteristics of possible antigenic peptide-preservative interaction in Salmon Calcitonin nasal spray
  • HPLC assay development, Agilent/ChemStation (RP, SEC and CEX), Capillary Electrophoresis (Beckman)
  • Highlights - Created test article Scopolamine Nasal Spray and Placebo formulations for use by NASA on the ISS in their motion sickness study
  • Lead on coordinating internal and external expertise for the approval of Nastech Salmon Calcitonin nasal spray addressing FDA concerns regarding preservative-API interaction and possible antigenicity
  • Key member of an internal team of researchers evaluating novel formulations for siRNA delivery, safety, and efficacy
  • Contributor and author on papers for nasal spray formulation development and excipients

Preclinical Research Associate, in vitro

EKOS Corporation
Bothell, USA
10.2001 - 09.2003
  • Blood clot melting catheter design and efficacy testing and safety evaluations in vitro and in vivo per-clinical trials
  • ELISA development; worked closely with engineering staff on design improvements
  • Highlight – Used prior research experience to develop several novel ELISA assays

Research Technician II

Fred Hutchinson Cancer Research Center
Seattle, USA
08.1994 - 09.2001
  • Protein expression, refolding and isolation for a crystallography group utilizing nearly all expression platforms (mammalian, insect, yeast and bacterial)
  • Analytical assessment of purity by FPLC, HPLC, SDS and IEF PAGE
  • Protein biochemistry and biophysics (CD, DLS/Particle Sizing and Biacore/Plasmon Resonance)
  • Highlight - Contributor and author on several publications on the immune system MHC Class 1 homologue and it’s ligand from various structure/function studies

Education

Effective Communication and Human Relations/Skills for Success -

Dale Carnegie
Bellevue, WA
12.2006

Masters graduate study - Yeast Vacuole Segregation During Zygote Formation and Separation

University of Iowa
01.1994

B.S. - Biochemistry/Cell and Molecular Biology – Biochemistry Emphasis

Western Washington University
01.1992

AAS - Pre-engineering, math, chemistry, biology and physics

Everett Community College
01.1988

Material Science Engineering -

Washington State University
01.1986

Skills

  • Cell Culture
  • Transfection/Transformation
  • Cell-based assay development
  • Drug screening assays
  • Cytokine analysis
  • MRNA analysis
  • Luminex/Quantigene technology
  • Protein expression/purification
  • Protein denaturation/refolding
  • In vitro assay development
  • EIA
  • ELISA
  • Chromatography
  • Electrophoresis
  • Protein Biophysics
  • Characterization
  • DSC, DLS, AUC, CD
  • Protein stability
  • Binding affinity
  • Enzyme kinetics
  • FPLC/HPLC/UPLC
  • Affinity and differential chromatography
  • Formulation technology
  • Peptide hormone and Small molecule formulation
  • Drug delivery technology
  • Assay development
  • RNAi/siRNA/knockdown assay development
  • Nanoparticle biophysical characterization
  • Technology transfer
  • Scale-up, process development
  • Clinical and pre-clinical drug manufacture
  • Method qualification and validation
  • Quality Control
  • Data systems/LIMS/ELN
  • Medical device technology
  • QC Biochemistry and Biophysics
  • Pre-commercial drug product development, fill and finish
  • Raw materials and Finished Product testing
  • Compendial methods/USP/EP
  • Oxygen analysis
  • API, Excipient and Preservative effectiveness testing
  • QA: Batch record review, Lot release
  • Stability and testing management
  • MS Office, Minitab, Prism, JMP
  • Critical thinking, decision making, Out-of-the-Box problem solving
  • Troubleshooting, Experimental design
  • Group lead and Laboratory management
  • Project management, Collaboration
  • Technology transfer liaison
  • Fast learner
  • Remodeling and Construction contracting

Certification

  • Radiation Safety/Management (RAM) Cert., WWU, 1990
  • Occupational Safety/Chemical Hygiene Blood-borne pathogens, FHCRC
  • Work Site First Responders/First Aid & CPR
  • Hazardous Materials Shipping, Nastech, 2005-2007

Selectedskills

Cell Culture: primary and immortalized cell and tissue culture: mammalian, insect and plant cell. Transfection, transformation and cell-based assay development. Drug screening assays, cytokine and mRNA analysis by Luminex and Quantigene (bDNA) technologies., Protein sciences: expression and purification, denaturation and refolding of proteins from nearly all biologic sources. In vitro assay development (EIA, ELISA under GLP). Chromatography and electrophoresis., Biophysics: characterization (DSC, DLS, AUC, CD and calorimetric analyses); protein stability and folding, binding affinity, enzyme kinetics. FPLC and HPLC: affinity and differential chromatography., Formulation sciences: protein, peptide hormone and small molecule API formulation technology and optimization. Nasal delivery technology/discovery and development for protein and peptides. Assay development (cell-based and in vitro) for efficacy, stability and permeation enhancement and safety (cytotoxicity/immunogenicity). RNAi delivery and knockdown assay development with nanoparticle biophysical characterization and optimization (stability, safety and efficacy). Technology transfer, scale-up and process development., Clinical and pre-clinical drug manufacture under cGMP; Method development and validation, Quality Control. Regulated data systems (LIMS), formulations and medical device technology and QC testing (nasal spray actuators and vascular drug-delivery catheters). Pre-commercial drug product development; fill and finish. Raw materials and finished product physical and chemical testing using compendial methods (USP, EP), dissolved and head-space oxygen and API/excipient/preservative analysis., Quality: QA and QC, Batch record review and lot release, stability program management and outsourced testing, product and raw materials testing and release., MS Office, statistics/graphics (JMP, Prism)., Critical thinking and decision making, problem solving and troubleshooting on compressed timelines for multiple projects, experimental design (DOE), group lead and laboratory/project management, collaboration on cross-functional groups, technology transfer and liaison for off-site vendors/contract services, fast learner, follow-through on tasks, wide and varied experience and skill sets in biotechnology, science, engineering, and remodeling/construction contracting.

Publications

  • Increased viral titer through concentration of viral harvests from retroviral packaging lines., Paul, R.W., et al., 1993, Human Gene Therapy, 4, 5, 609-615
  • Crystal structure of the MHC class I homolog MICA, a gamma-delta T-cell ligand., Li, P.W., et al., 1999, Immunity, 10, 577-584
  • Complex structure of the activating immunoreceptor NKG2D and its MHC class I-like ligand, MICA., Li, P.W., et al., 2001, Nature Immunology, 2, 5, 443-451
  • Interactions of human NKG2D with its ligands MICA, MICB and homologs from the mouse RAE-1 protein family., Steinle, A., et al., 2001, Immunogenetics, 53, 4, 279-287
  • Therapeutic utility of a novel tight junction modulating peptide for enhancing intranasal drug delivery., Chen, S. et al., 2006, J Pharm Sci., Jun, 95, 6, 1364-1371
  • Development of Calcitonin Salmon Nasal Spray: Similarity of peptide formulated in chlorobutanol compared to benzalkonium chloride as preservative., Costatino, H.R., et al., 2009, J. Pharm. Sci., Oct, 98, 10, 3691-3706

Timeline

QC Team Lead: Global Stability, Outsourced Testing and LIMS Administrator

Inventprise, Inc.
02.2021 - Current

Dept Supervisor/Sales Associate

The Home Depot
04.2017 - 02.2021

QA Associate III

CMC Biologics (Contractor through Com-Force)
05.2016 - 12.2016

Sales Associate

Home Depot
03.2016 - 06.2016

Sales Associate

Lowe’s Home Improvement
02.2015 - 03.2016

Property Manager and Remodeling Contractor

LAM Properties
01.2014 - Current

Sales Associate

Home Depot
08.2013 - 12.2014

Senior Scientist

Amgen (Contractor through Lancaster Labs, Inc.)
05.2012 - 10.2012

Associate Scientist

Amgen (Contractor through Aerotek Scientific)
01.2011 - 06.2011

Senior Research Associate II, Biology

Gilead Sciences, Inc.
03.2008 - 10.2010

Research Associate IV

Nastech Pharmaceutical Company, Inc.
10.2003 - 11.2007

Preclinical Research Associate, in vitro

EKOS Corporation
10.2001 - 09.2003

Research Technician II

Fred Hutchinson Cancer Research Center
08.1994 - 09.2001

Effective Communication and Human Relations/Skills for Success -

Dale Carnegie

Masters graduate study - Yeast Vacuole Segregation During Zygote Formation and Separation

University of Iowa

B.S. - Biochemistry/Cell and Molecular Biology – Biochemistry Emphasis

Western Washington University

AAS - Pre-engineering, math, chemistry, biology and physics

Everett Community College

Material Science Engineering -

Washington State University
  • Radiation Safety/Management (RAM) Cert., WWU, 1990
  • Occupational Safety/Chemical Hygiene Blood-borne pathogens, FHCRC
  • Work Site First Responders/First Aid & CPR
  • Hazardous Materials Shipping, Nastech, 2005-2007
DANIEL L. MORRIS