Joseph Bernacki

Joseph Bernacki Email and Phone Number

Scientific Associate Director @ Amgen
thousand oaks, california, united states
Joseph Bernacki's Location
Thousand Oaks, California, United States, United States
Joseph Bernacki's Contact Details

Joseph Bernacki personal email

n/a
About Joseph Bernacki

I strive to balance technical rigor, scientific principles, engineering fundamentals, regulatory and quality requirements, business processes, organizational structures, intellectual property, staff personalities, and financial realities to identify and implement meaningful solutions given these multifaceted constraints.I selected chemical engineering upon entering college because I loved chemistry and math, and I am fortunate to have joined a field so well aligned with my instincts and interests. My Ph.D. thesis investigated disease-related protein aggregation via both experimental and mechanistic modeling techniques, enabling me to apply fundamental physics and chemistry concepts at the interface of biology and medicine to interpret the results in accordance with statistical and engineering principles.I joined Amgen in 2011, supporting biologics drug commercialization activities including product and process characterization, technology transfers, and regulatory filings. I transitioned to platform and technology development work in 2014, including establishing biologics drug product platforms, operationalizing a fill-finish pilot plant, implementing digital and big data information systems, and fostering intellectual property generation in Amgen Process Development. I transitioned into a leadership role in 2018, guiding multisite teams of scientists, engineers, and data scientists ranging from undergraduate interns to high professional subject matter experts with decades of experience as we implement cutting edge technology into Amgen Operations.I enjoy the challenge of learning new things, and I believe I bring value by applying my broadening perspective to every new activity so that our teams deliver increasingly robust and comprehensive solutions.My spouse and I are proud parents of two young children, who delight and enlighten us every day.My opinions are my own and do not represent the positions of any entity I have a connection to.

Joseph Bernacki's Current Company Details
Amgen

Amgen

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Scientific Associate Director
thousand oaks, california, united states
Website:
amgen.com
Employees:
27715
Joseph Bernacki Work Experience Details
  • Amgen
    Scientific Associate Director
    Amgen Jul 2023 - Present
    Thousand Oaks, California, United States
    • Head of the Manufacturing Technology Advancement organization, leading global teams of 15 scientists, engineers, and data scientists with differentiated skills proving concepts and spearheading CGMP operationalization into the end-to-end global Manufacturing network• Enabling knowledge management and mentorship for high professional staff with unique skills• Shepherding 64 (and counting as of 2024) provisional patent applications by inventors in our organization related to biopharmaceutical drug substance, drug product, and final product (assembly, labeling, packaging) manufacturing processes and related domains
  • Amgen
    Senior Principal Scientist
    Amgen Nov 2019 - Jun 2023
    Thousand Oaks, California, United States
    • Formalized an innovation governance process to manage manufacturing technology solutions from laboratory proof-of-concept to CGMP implementation and lifecycle management• Leading the Amgen Visual Inspection Governance technology pillar driving advancements such as deep learning and robotics into CGMP parenteral drug product visual inspections
  • Amgen
    Principal Scientist
    Amgen Jan 2019 - Oct 2019
    Thousand Oaks, California, United States
    • Founded and team led the Amgen Advanced Technology and Automation group of diverse, highly specialized scientists, engineers, data scientists, and automation system owners• Managed a team of 5-10 fulltime staff, interns, and postdoctoral candidates with highly specialized engineering, machine vision, artificial intelligence, robotics, and fabrication skills
  • Amgen
    Senior Scientist
    Amgen Jan 2016 - Dec 2018
    Thousand Oaks, Ca
    • Developed subject matter expertise in sterile filtration validation and drug product fill-finish technologies, including piston pump filling, time-over-pressure filling, and peristaltic filling• Developed and implemented drug product platforms, including first intent in-process control and realtime release testing strategy as well as ISA-88-compliant process hierarchy for biologics• Operationalized a biologics drug product manufacturing pilot facility, including three distinct filling lines, and leveraged capabilities to optimize technology transfer activities across network• Led the Amgen IP4PD initiative, establishing processes to secure intellectual property; reviewed hundreds of potential patent applications with attorneys; assessed natural language processing techniques to expedite freedom to operate, patentability, and IP landscaping efforts• Contributed to the Amgen IS4PD initiative, collaborating with IT to implement ‘big data’ technologies including an electronic laboratory notebook environment, a data lake with embedded dynamic visualization, and taxonomy development for robust data architecture
  • Amgen
    Scientist
    Amgen Jun 2011 - Dec 2015
    Thousand Oaks, Ca
    • Designed and executed fill-finish process development studies for a parenteral biologic drug product, including formulation, filtration, filling, container closure, and inspection• Collaborated with cross-functional internal and external partners to support cGMP clinical manufacturing, commercial technology transfer, and commercial process validation• Authored Marketing Application sections for drug product process development and supported pre-approval inspection activities for the global launch of biologic drug products
  • University Of Wisconsin-Madison
    Research Assistant (Graduate Student)
    University Of Wisconsin-Madison Aug 2005 - May 2011
    Madison, Wi
    • Developed rigorous statistical techniques to evaluate protein aggregation models, quantifying the type and quality of data necessary to determine underlying aggregation mechanisms• Designed and produced novel synthetic polyalanine peptides as a model experimental system for studying disease-related protein aggregation (e.g., Huntington’s or Alzheimer’s Diseases)• Utilized multiscale biophysical assays to characterize protein aggregation, including dynamic and static light scattering, chromatography, circular dichroism, and fluorescence spectroscopy• Developed novel data analysis techniques to interpret multivariate laser light scattering data
  • University Of Connecticut
    Undergraduate Honors Researcher
    University Of Connecticut Aug 2004 - May 2005
    Storrs, Ct
    • Managed an individualized research project with Professor Ranjan Srivastava (Chemical Engineering); wrote and defended formal honors thesis based on the project• Designed experiments and mathematical models to investigate virus-bacteria-antivirus systems
  • Owens Corning
    Science And Technology Intern
    Owens Corning May 2004 - Aug 2004
    Granville, Oh
    • Designed and executed experiments to simulate in-field conditions and recommend Siding Solutions product modifications; formally documented all work as intellectual property
  • University Of Connecticut
    Undergraduate Researcher
    University Of Connecticut May 2002 - Aug 2003
    Storrs, Ct
    • Designed combinatorial rheological equipment to measure asphalt properties for correlation to on-road performance with Professor Patrick Mather (Materials Science)• Synthesized and characterized nanoscale ceramic composites with Professor Joseph Helble (Chemical Engineering) utilizing spray pyrolysis, electron microscopy, and x-ray diffraction

Joseph Bernacki Skills

Biotechnology

Joseph Bernacki Education Details

Frequently Asked Questions about Joseph Bernacki

What company does Joseph Bernacki work for?

Joseph Bernacki works for Amgen

What is Joseph Bernacki's role at the current company?

Joseph Bernacki's current role is Scientific Associate Director.

What is Joseph Bernacki's email address?

Joseph Bernacki's email address is jb****@****isc.edu

What is Joseph Bernacki's direct phone number?

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What schools did Joseph Bernacki attend?

Joseph Bernacki attended University Of Wisconsin-Madison, The University Of Connecticut.

What are some of Joseph Bernacki's interests?

Joseph Bernacki has interest in Science Advocacy, Pickup Sports, Zymurgy, Reading, Hiking, Camping, Running, Music, Intramural Sports, Mountain Biking.

What skills is Joseph Bernacki known for?

Joseph Bernacki has skills like Biotechnology.

Who are Joseph Bernacki's colleagues?

Joseph Bernacki's colleagues are Garry Devine, Cep, Mba, Magalie De La Torre, Dylesha James, Erik Van De Mosselaar, Michael Green, Christine Wurmbrand, Cecilia Dominguez.

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