Gary S.

Gary S. Email and Phone Number

Delavan, WI, US
Gary S.'s Location
Idaho Falls, Idaho, United States, United States
Gary S.'s Contact Details
About Gary S.

With over 20 years of experience, I am a seasoned leader and innovator in in biopharmaceutical process development and manufacturing. Currently, I manage the operations personnel and provide strategic direction for PharmaLogic Holdings Corp., a targeted radiopharmaceutical CDMO that delivers high-quality products for patients and customers.My core competencies include bioprocess development, process validation, quality system implementation, lean practices, and research project management. I have successfully implemented process optimization and quality improvement initiatives that have resulted in increased efficiency, compliance, and product delivery. I have also contributed to multiple patents and publications that demonstrate my expertise and passion for biopharmaceutical research and development. My goal is to leverage my skills and experience to drive innovation and excellence in the biopharmaceutical industry.

Gary S.'s Current Company Details
NorthStar Medical Radioisotopes, LLC

Northstar Medical Radioisotopes, Llc

View
Director, CDMO
Delavan, WI, US
Website:
northstarnm.com
Employees:
312
Gary S. Work Experience Details
  • Northstar Medical Radioisotopes, Llc
    Director, Cdmo
    Northstar Medical Radioisotopes, Llc
    Delavan, Wi, Us
  • Pharmalogic Holdings Corp.
    Manager Of Manufacturing Operations
    Pharmalogic Holdings Corp. May 2023 - Present
    Boca Raton, Fl, Us
    Manages Operations personnel and assumes the role of a strategic manager overseeing the company'sproduction operations focused on targeted radiopharmaceutical manufacturing. Offer comprehensive technicalsupport for all Chemistry, Manufacturing, and Controls (CMC) activities, encompassing investigations,Corrective and Preventive Actions (CAPAs), Change Controls, technology transfers, and the operation andlifecycle management of current Good Manufacturing Practice (cGMP) manufacturing processes. Ensures thetimely fulfillment of all product delivery schedules.Presently managing the final stages of construction and site commissioning. Spearheading the implementationof a comprehensive site validation program, which encompasses the creation of a site Validation Master Plan(VMP), validation SOPs, URS templates, and the development of a training program tailored for Engineeringand Operations personnel.
  • Vmrd, Inc.
    Process Engineer
    Vmrd, Inc. Sep 2022 - May 2023
    Pullman, Wa, Us
    Responsible for process optimization, research, and development of new processes for in-vitro diagnostic products. Implemented lean practices for improved efficiency.
  • Pharma Tech Industries
    Site Director
    Pharma Tech Industries Oct 2020 - Sep 2022
    Athens, Georgia, Us
    Provided leadership and direction to 120+ production personnel and engineering staff in a pharmaceutical and medical device contract manufacturing setting.
  • Pharma Tech Industries
    Senior Director Of Engineering And Technical Services
    Pharma Tech Industries Mar 2020 - Oct 2020
    Athens, Georgia, Us
    Led Process Engineering and Validation functions, supported commercial operations, and facilitated site-wide continuous improvement initiatives.
  • Thorne Research
    Engineering Manager
    Thorne Research Mar 2015 - Feb 2020
    New York, New York, Us
    Oversaw the expansion of engineering capabilities, relocation of commercial operations, and startup of Process Development facilities and implementation of a state of the art Pilot Plant.
  • Alk-Abello
    Senior Process Development Engineer
    Alk-Abello May 2007 - Mar 2015
    Hoersholm, Dk-2970, Dk
    Led process development for allergy vaccine source materials and design of solid state bioreactors, ensuring global demand and regulatory compliance.
  • Icos Biologics:  Acquired By Cmc Biologics In 2007
    Manufacturing Specialist
    Icos Biologics: Acquired By Cmc Biologics In 2007 Mar 2006 - May 2007
    Bothell, Wa, Us
    Managed equipment, process improvements, and project management in biologics manufacturing, focusing on aseptic processing and compliance.
  • Dendreon
    Process Validation Engineeer
    Dendreon Jan 2004 - Jan 2006
    Seal Beach , Ca, Us
    Contributed to the development and validation of Provenge®, a groundbreaking immunotherapy for prostate cancer treatment.
  • Zymogenetics
    Senior Research Associate
    Zymogenetics Jul 2001 - Jan 2004
    Seattle, Washington, Us
    Now part of BMS.Responsible for bioreactor process optimization and process scale-up for clinical trial manufacturing.
  • Novozymes
    Senior Research Associate
    Novozymes Jan 1998 - Jul 2001
    Bagsvaerd, Dk
    Managed microbial fermentation experiments, tech transfer, and scale-up of fermentation processes.

Gary S. Skills

Gmp Validation Biotechnology Fda Biopharmaceuticals Technology Transfer Quality System Microbiology Process Simulation V&v Laboratory Process Development Capa Quality Control Fermentation Process Validation U.s. Food And Drug Administration Aseptic Processing Continuous Improvement Sop Change Control Purification Glp Cell Culture Research Project Management 21 Cfr Part 11 Clinical Development Commercialization Protein Expression Process Flow Technical Writing Quality Systems Contract Manufacturing Vaccines Ms Project Clinical Trials Project Engineering Manufacturing Quality Assurance Leadership Management Microsoft Office

Gary S. Education Details

  • Washington State University
    Washington State University
    Microbiology
  • Washington State University
    Washington State University
    General

Frequently Asked Questions about Gary S.

What company does Gary S. work for?

Gary S. works for Northstar Medical Radioisotopes, Llc

What is Gary S.'s role at the current company?

Gary S.'s current role is Director, CDMO.

What is Gary S.'s email address?

Gary S.'s email address is ga****@****mrd.com

What is Gary S.'s direct phone number?

Gary S.'s direct phone number is +120826*****

What schools did Gary S. attend?

Gary S. attended Washington State University, Washington State University.

What are some of Gary S.'s interests?

Gary S. has interest in Science And Technology, Education, Economic Empowerment, Health.

What skills is Gary S. known for?

Gary S. has skills like Gmp, Validation, Biotechnology, Fda, Biopharmaceuticals, Technology Transfer, Quality System, Microbiology, Process Simulation, V&v, Laboratory, Process Development.

Who are Gary S.'s colleagues?

Gary S.'s colleagues are Kuney Marc M., Austin Smith, Diane Abou, Ric Land, Linda Heide, Allison Greving, Melissa Moyer.

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