Sven McKinney
Summary
As a highly skilled and experienced Analytical Development Scientist, I possess extensive knowledge and expertise in pharmaceutical/biopharmaceutical cGMP Quality Control (QC) assays. I am a recognized Subject Matter Expert (SME) and technical leader with a proven ability to develop new techniques and troubleshoot complex issues. I have a track record of leading scientific investigations, designing and executing complex experiments to test hypotheses, analyzing intricate data, and drawing sound conclusions. I am dedicated to enhancing analytical strategies and technical capabilities by staying up-todate with the latest industry trends and practices. As a team player, I am able to identify priorities within multiple tasks and quickly transition to reprioritize when needed by the business. I am proactive in sharing knowledge and training others in multiple areas of expertise. My goal is to provide exceptional leadership, collaborate with cross-functional teams, and achieve organizational goals.
Experience
Video Life Coach
- Self-hosted e-Community Center
May 2023 - Present
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Digital Health Architect: Built encrypted, self-hosted
platforms combining full-stack development with curriculum
design rooted in philosophy, enabling user-driven virtual
care experiences.
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Telehealth Facilitator: Certified by AgeSpan in the Stanford
Chronic Disease Self-Management Program (CDSMP); led Zoom
sessions in clinical trials for burn survivors through the
Boston-Harvard Burn Injury Model System.
The Outreach Team
- Remote / Field-based statewide
July 2024 - November 2024
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Public Engagement Specialist: Earned promotion for proactive
impact. Delivered culturally sensitive communication across
New York and Pennsylvania, fostering trust and encouraging
civic participation.
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Remote Campaign Ops: Improved QC of public forms and led
full-cycle talent acquisition to complete campaigns across
AZ, CA, GA, MI, MN, NC, NH, NV, NY, PA, SC, VA, and WI.
Sourced, screened, interviewed, and onboarded hundreds
weekly through collaborative, remote teamwork.
Regeneron
- Rensselaer, NY
September 2019 - May 2023
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Method Development: Developed analytical methods for
biologics in clinical trials and commercial products,
including purity by SEC, impurity detection, assay
transfers, and quality control for release testing and
in-process pools.
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Reference Characterization: Executed qualification protocols
for reference standard characterization, performing diverse
assays including FTIR, peptide mapping with trypsin
digestion, molecular weight and tertiary structure analysis.
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Instrumentation & Automation: Coordinated installation,
validation, maintenance, and troubleshooting of advanced
analytical equipment, automated pipetting systems, solution
preparation, and laboratory data management.
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Documentation & Compliance: Authored GMP documents and led
cross-functional collaboration to ensure edits are in full
adherence to change controls, regulatory compliance, and
traceability in QUMAS EDMS and Blue Mountain RAM.
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Cross-Site Collaboration: Enabled efficient coordination
between the HQ in Tarrytown, NY, the new foreign
manufacturing site in Ireland, and global vendors.
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Training & Mentorship: Trained and mentored new hires and
peers, supporting assay transfer, method troubleshooting,
and instrument onboarding.
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Community Leadership: Co-founded and led outreach
initiatives focused on environmental and community support.
Sciarra Labs
- Hicksville, NY
July 2019 – August 2019
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Employed subject matter expertise using UPLC test methods
for cGMP quality of aerosol drug products such as metered
dose inhalers, nasal sprays, dental, and rectal foams.
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Recorded in a laboratory notebook experiments with ATR FTIR,
coulometric KF, and microscopic evaluation for assay and
identification.
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Resolved method discrepancies, improved reporting with
custom field programming, and suggested process improvement
using robotic efficiency and accuracy.
Curia
- Rensselaer, NY
January 2019 - June 2019
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Reviewed the quality of large scale cGMP manufacturing of
bulk active pharmaceutical- ingredients (APIs), as well as
process development and scale-up.
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Conducted testing of USP/EP/JP monographs according to
FDA/ICH/ISO guidelines with attributable, legible,
contemporaneous, original, and accurate records.
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Maintained the safety for millions of doses of
over-the-counter medicine, in investigational new drug
clinical trials, and in multiple stages of chemical
manufacturing intermediates.
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Operated chromatography (Empower HPLC and TotalChrom Perkin
Elmer GC), spectroscopy, (TopSpin Bruker NMR and Qtegra
ICP-MS) and other instrumentation (Tiamo volumetric,
coulometric, and potentiometric Karl Fischer titrations).
3M
- Cottage Grove, MN
December 2017 - December 2018
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Lead chemical analysis at the Corporate Incinerator for the
entire organization’s plants nationwide to meet disposal and
transportation guidelines by the EPA and DOT.
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Communicated with teams for changes based on analytical test
results and implications.
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Developed and implemented new information systems and
equipment installations.
Medtronic
- Fridley, MN
April 2017 - August 2017
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Contracted as an analytical chemist in the chemical
technologies division to perform acceptance testing on
various medical device components using advanced
instrumentation.
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Tested for cleanliness by counting particles less than 5 μm
in size, measuring ionic contamination, and analyzing total
organic carbon.
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Utilized the attenuated total reflectance technique for
infrared spectroscopy.
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Dissolved metals using strong acids and analyzed the
elemental composition using inductively coupled plasma.
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Documented procedures in an Electronic Laboratory Notebook
(ELN) and test data and results into Laboratory Information
Managements Systems (LIMS) and Material Analysis and
Qualification Systems (MAQS).
Eurofins
- Mounds View, MN
August 2015 - April 2017
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Performed AOAC methods in an ISO 17025 accredited chemistry
lab and passed an audit.
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"Analyzed the colloidal composition of various dairy
products, typically milk protein and fat.
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"Controlled waters HPLC through empower software to evaluate
sugar content in milk.
Cantel
- Plymouth, MN
May 2015 - July 2015
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Conducted test methods to maintain quality for a GMP medical
device facility.
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Performed titrations and atomic emission spectroscopy to
test bicarbonate and sodium levels of thousands of gallons
of hemodialysis buffer to shipped worldwide.
Pace Analytical
- Minneapolis, MN
July 2013 - August 2013
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Performed water quality testing methods according to state
and federal standards.
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Tested commercial products for their ability to filter out
trace quantities of lead.
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Developed and restructured new lab space and workflow
designs.
Education
University of Minnesota - Twin Cities
August 2010 - May 2011
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Additional coursework from the college of continuing
education.
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Focused on spectroscopy theory, structural analysis, and
multidimensional NMR analysis.
Winona State University
August 2007 - December 2009
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Earned a four year bachelors of science in chemistry degree
in 2½ years with a 3.5 GPA.
Skills
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Proficient in a broad array of analytical instrumentation and
techniques, covering spectroscopy (UV-Vis, IR, NMR, ICP),
chromatography (LC, GC, GC-MS and LC-MS/MS), material property
analyses, microscopy, molecular biology, wet chemistry, and data
analysis (Empower, JMP, LLM training), while adhering to safety
and compliance standards.
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Demonstrated proficiency in diverse computer science skills,
including the ability to quickly adapt to new programming
languages, web development frameworks, database management,
cloud computing platforms, cybersecurity principles, machine
learning, and networking concepts.
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Fluent in Norwegian and German, with extensive international
travel experience.