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Project Management Test Manager

Location:
Nutley, NJ
Posted:
January 26, 2024

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Resume:

Sandra L. Schnakenberg, PhD

* ******* **., ********** ** 07003 917-***-**** ad238a@r.postjobfree.com

PROFESSIONAL EXPERIENCE

GeneDx (formerly Sema4), Stamford, CT December 2020- December 2023 NYS License R000413

Pharmacogenomics Test Manager; Division Head: Bronwyn Ramey, PhD

• Liasoned with cross-functional teams to operationalize multiplex ligation-dependent probe amplification, capillary electrophoresis, and Agena MassARRAY iPLEX tests for high throughput processing of a pharmecogenomics (PGx) single nucleotide polymorphism panel and copy number detection of CYP2D6. Reduced turn-around-time from 8 to 5 days.

• Worked with the internal team and external clients to scope, plan, and onboard various studies. One example is the Avera ASAP Study which aims to identify targeted, personalized treatment options to advance the field of precision oncology

• Maintained schedules for testing, staffing and training. Wrote PGx related SOPs and competency documents.

• Monitored chain of custody of all samples and ensured issues were raised to appropriate teams to prevent delays.

• Led the development and validation of the SNP panels while maintaining records in accordance with CAP and CLIA regulatory standards.

• Standardized internal work flows and monitored testing for the following pragmatic clinical trials: ADOPT-PGx study for depression and opioid pain management & GUARRD-US study which identifies APOL1 risk variants in patients undergoing treatment for hypertension.

• Trained ABMGG Lab Genetics and Genomics Fellows on copy number and Agena Typer software single nucleotide polymorphism detection analysis and reporting.

• Designed a UConn student internship project for preliminary validation of CYP2D6 copy number variation identification on the QuantStudio Flex 7. Primary Analyst I

• Closed Stamford CT facility after merger and transistioned to remote work for Gaithersburg MD location starting in April 2023.

• Provided technical support for the transition of PGx from a three pronged workflow that included Multiplex ligation-dependent probe assay, capillary electrophoresis, and the Agena MassARRAY iPLEx SNP detection technology to the Illumina Infinium Global Diversity Array with Enhanced PGx.

• Wrote PGx related analysis, training, and competency SOPs for the Igentify Analyze workflow.

• Provided troublehooting expertise to enhance Igentify Analyze software algorithm deviations.

• Supported the whole exome sequencing analysis team by determining best reflex test for copy number variations of exomes.

Clinical Project Management Healthcare Industry

Clinical diagnostics testing expert with a background in academics managing independent research projects, culminating in a unique position to coordinate and lead highly complex projects in the healthcare industry. Results-oriented leader skilled in the areas of molecular biology, project management, and research, currently working in the field of pharmacogenomics diagnostic testing. Recognized for the ability to manage all aspects of operations while ensuring the adherence to regulatory and CLIA guidelines.

• Project Management

• People Management

• Expert troubleshooter

• Boundry Spanner

• Adaptable

• Self Motivated

Icahn School of Medicine at Mount Sinai, New York, NY July 2019- December 2020 Neuropathology Brain Bank & Research CoRE

Manager- Senior Scientist; Director: Prof. John Crary MD

• Project manager for all histology projects focused on research of dementia associated disorders.

• Managed and reduced cost of goods and increased profits by 30% through negotiations with key vendors.

• Developed and approved contracts, billing and payment collections, and directed day-to-day operations of brain bank business.

• Provided organizational support for projects that pertain to LETBI and CTE related disorders.

• Established a BL2 facility during the COVID-19 pandemic to process brain tissue required for research.

• Managed histology and tissue selection for a BMCA CAR-T study that led to a publication in Nature Medicine.

Sema4, New York, NY May 2016 - August 2019

Clinical Genetics Laboratory Manager (NYS License R000413)

• Managed the SNP detection assay and conducted data analysis for a companion asssay of the expanded carrier screen using the Agena MassARRAY iPLEX platform.

• Redesigned the Agena platform workflow and reduced turn around time from 14 to 6 days. Sloan Kettering Institute, New York, NY January 2013 - December 2014 Postdoctoral Fellow; Principle Investigator: Prof. Jennifer Zallen

• Project: The identification of effectors of late embryonic patterning systems involved in cytoskeletal organization and cell shape changes of the Drosophila epithelium. New York University, New York, NY September 2004-January 2012 Principle Investigator: Prof. Mark Siegal

• Thesis Projects: Characterization of the role of the spermathecal secretory cells in the reproductive tract of female Drosophila melanogaster.

Research Scientist

The Hebrew University, Rehovot, Israel (March to May, 2011) Principle Investigators: Prof. Yael Heifetz and Prof. Mark Siegal

• Project: Complimentary profiling of gene expression and proteome levels of the female Drosophila mating response in the absence of the spermathecae secretory cells.

• Project Manager for BARD study- reduced length of project from 6m to 3m by organizing, managing all aspects of the study, including staffing, scheduling, and specimen processing. Research Scientist

Rutgers University, Piscataway, NJ (April to November, 2012) Principle Investigator: Prof. Kevin Chen and Prof. Mark Siegal

• Project: Characterization of piRNA dynamics on the suppression of transposable elements in the Drosophila ovary.

• Designed and performed the experimental sample preparation that led to a publication. Princeton University, Princeton, NJ August 1997-August 2004 Laboratory Manager

Principle Investigator: Prof. Virginia A. Zakian

• Projects: The role of POL3, DNA2, and RAD27 on trinucleotide repeat (TNR) fluctuations in vivo in Saccharomyces cerevisiae. Function of DNA helicases SGS1 and RRM3 on DNA replication. PROFESSIONAL SKILLS

Molecular and Cellular Biology

Preparation, enzymatic editing and analysis of DNA (plasmid, genomic, cDNA, and Southern Blot); DNA sequencing; Agena MALDI-TOF screening; MLPA incuding DNA methlylation analysis, Cesium chloride DNA preparation and Two-Dimensional DNA Electrophoresis; Northern analysis; PCR (analytical, cloning, genotyping, quantitative, and RT-PCR); preparation of RNA for microarray analysis; RNA interference (RNAi); NGS RNAseq; construction and screening of cDNA libraries; Northern Blot; Bacterial, yeast, and mammalian cell culture and transfection

(including establishment of stable cell lines); subcellular fractionation by differential and density gradient centrifugation; Preparation and analysis of proteins; bacterial and insect cell protein expression; affinity protein purification; polyclonal antibody production and characterization; analysis of protein-protein interactions and protein-DNA interactions (yeast two-hybrid and one-hybrid systems, ELISA, Co-IP); starch, SDS-PAGE and IEF gel separation of proteins; Western analysis. Spinning disc and laser confocal microscopy. Operating Systems and Software Applications

Macintosh OS, Windows; ImageJ64, Microsoft Office, Endnote, PowerPoint, Adobe InDesign, Tableau, and Dropbox; Working knowledge of Google Drive, Adobe Photoshop, Illustrator, and Premiere; GeneMapper, GeneMarker, Typer, Medgis, LIMS, Cartogenia, Alamut, IGV, ExAC, gnomAD, ClinVar, HGMD and UCSC genome browser.

CERTIFICATES

Project Management from Cornell University in 2019. Pharmacogenomics: Genes, Drugs, and Genotyping: AMP Pharmacogenomics Guidelines in 2023. EDUCATION

Doctor of Philosophy in Biology, 2012

New York University, New York, NY

Dissertation: The role of the spermathecae in female Drosophila reproduction. SELECT PUBLICATIONS

Oliver Van Oekelen, Adolfo Aleman, Bhaskar Upadhyaya, Sandra Schnakenberg, et al., Neurocognitive and hypokinetic movement disorder with features of parkinsonism after BCMA-targeting CAR-T cell therapy. Nature Medicine, 2021 Dec 10 (27) Song, J., Liu, J., Schnakenberg, S.L., Ha, H., Xing, J., and Chen, K. C. Variation in piRNA and transposable element content in strains of Drosophila melanogaster. Genome Biology and Evolution, 2014 Sep 29;6(10).

Schnakenberg, S.L., Siegal, M.L., Bloch Qazi, M.C. (Invited) Oh, the places they’ll go: Female sperm storage and precedence in Drosophila melanogaster. Spermatogenesis, 2012 Jul 1;2(3).

Schnakenberg, S.L., Matias, W.R., Siegal, M.L.

Sperm storage defects and live birth in Drosophila females lacking spermathecal cells. PLoS Biology, 2011 Nov 9(11).



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