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Process Validation Medical Device

Location:
Timonium, MD
Posted:
April 15, 2024

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Resume:

JACOB STRAUCH

*** ******** ***** **. • Lutherville, MD 21093

mobile: 443-***-**** • ad401y@r.postjobfree.com

Biotechnology Graduate

Accomplished recent graduate with a master’s in biotechnology and an MBA. Strengths include an inquisitive nature with the ability to complete complex tasks on time while adhering to GLP principles. Interested in utilizing my multifaceted educational background to obtain a position exploring the development and manufacturing of biopharmaceutical products. I am also bilingual as an English native speaker with proficiency in Spanish.

Upstream/Downstream Bioprocessing Data Analysis and Data Monitoring SQL Programming/ Data Mining

Immunoassay Good Laboratory Practice (GLP) Design of Experiments (DOE)

Medical Device Process Validation Detail Oriented IHC Staining

PROFESSIONAL EXPERIENCE

Artemis Plastics, Ocala, Florida

February 2024 to Current

Artemis Plastics is a contract manufacturer that specializes in the production and assembly of injection molded plastic components, serving domestic and international medical markets. Artemis Plastics is a leading provider of injection molded plastics products and comprehensive manufacturing solutions for medical devices. Artemis Plastics uses state of the art injection molding equipment and expertise to produce high-precision and complex parts.

Process Validation Technician (Contract)

Analyzing manufacturing specifications based on outlined protocols to ensure that a product is manufactured in accordance with appropriate regulatory agency validation requirements, internal company standards, and current industry practices. Ensuring proper documentation of the manufacturing feedback to subsequently place in a performance qualification and operational qualification report.

Analyze the measurements recorded during the plastic manufacturing process to document scientific proof of consistent performance.

Perform various statistical analysis techniques through Minitab to validate the dimensional requirements of manufactured plastics and translate this information into Performance Qualification (PQ) reports.

Inspect and analyze equipment features that have the potential to impact product quality and translate this information into Operational Qualification (OQ) reports.

Verify and document the user requirements of the manufactured plastics are met as per the guidelines outlined by ISO: 9001 and ISO 13485.

University of Maryland School of Medicine, Baltimore, MD

Kaushal Lab May 2019 to January 2020

The Kaushal lab is a research lab focused on studying cell based regenerative therapies for various forms of heart failure. The lab primarily studies the utility of cardiac mesenchymal stem cells (MSCs) on patients with various forms of heart failure including hypoplastic left heart syndrome (HLHS) a life-threatening condition afflicting infants. Personal contributions to this lab were accredited in a research paper titled “GDF-15 Enriched Exosomes derived from Mesenchymal Stem Cells Preserve Right Ventricular Function in Swine Model of Right Ventricle Overload,” to be published in the International Journal of Molecular Sciences in 2024.

Laboratory Technician

Assisted in large animal surgeries and was responsible for the subsequent fixation, sectioning, and histological staining of the collected tissue specimen.

Led a team of three undergraduate interns to fixate and section tissue samples from a multi-year series of animal surgeries.

Performed Masson’s Trichrome stains to quantify MSC mediated cardiomyocyte repair after a surgically facilitated MI.

Performed an assortment of IHC staining protocols using conjugated monoclonal antibodies to quantify cardiomyocyte hypertrophy in the aftermath of an MI.

Performed digital imaging analysis procedures on all histological stains performed with the purpose of providing quality data for the research paper.

Performed Ion Exchange Chromatography to isolate a target protein to be subsequently quantified with Coomassie Blue.

Designed and implemented multiple SOPs.

Assisted in over 20 large animal surgeries that adhered to IACUC protocols.

Assisted in the writing of scientific manuscripts.

University of Maryland School of Medicine, Baltimore, MD

Simard Lab May 2018 to September 2018

The Simard lab is a research lab dedicated to studying a nonselective cation channel referred to as SUR1-TRMP4, which when opened via ATP depletion has been found to exacerbate cerebral edema caused by stroke or other forms of head trauma.

Laboratory Intern

Maintained several modified cell lines using fetal bovine serum to be used for subsequent experimentation.

Created a luciferase construct to quantify the gene expression of a target gene referred to as “TRMP4.”

Utilized other laboratory based molecular biology techniques including PCR and qPCR to quantify the differential gene expression of TRMP4 among different individual rodents.

Maintained laboratory records and monitored data quality, ensuring adherence to Good Laboratory Practice (GLP) standards.

Performed immunoassays including ELISA and Western Blot to quantify the presence of target proteins.

EDUCATION AND TRAINING

Master of Business Administration, Data Analytics

Loyola University Maryland, expected graduation May 2023, GPA 3.70

Master of Professional Studies, Biotechnology

University of Maryland, Baltimore County, December 2021, GPA 3.5

Bachelor of Science, Biology

University of Maryland, College Park, August 2020, GPA 3.4

Semester academic honors: Fall 2016, Spring 2018, Spring 2020



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