Linda Hylander

Billerica, MA *****

c- 617-***-****

adxkeu@r.postjobfree.com

Summary

-Dependable, self-aware, analytical quality professional devoted to biomedical product development within biopharmaceutical and medical device companies and anatomic pathology laboratories requiring a strong understanding of oncology operations and dedicated leadership to meet business strategies.

-Proven quality manager within biomarker product development, histopathology operations, increased laboratory revenue, validated new diagnostic platforms or application capabilities.

-Development Operations manager builds knowledge and technical expertise in companion diagnostics (CDx) arena Ensures compliance in personalized medicine and healthcare industry.

-Improves quality management system (QMS) ISO 13485: 2016 IVD experience, CAPA remediation, solve complex problems, quality metrics, supplier management, document manager.

-Exceptional organizational skills, strategic decision maker, CAPA problem solver, CAP/CLIA inspector, GxP compliance, proficient MS Office, Teams, Gensuite, LIMS Copath, workflow consultant, laboratory diagnostics

Education

-Bachelor’s of Science Degree - Biology, University of Massachusetts, Boston, MA

-Qualification in IHC (QIHC) - American Society of Clinical Pathology 1998

-Good Laboratory Practice Course, Center for Professional Advmt NJ 2002

-Clinical Research Training Course, National Institute of Health 2004

-Regulatory Affairs Professional Society (RAPS) member since 2005

Employment History

Leica Biosystems, Danvers, MA September 6, 2016 to October 4, 2022

Development Operations Manager, Companion Diagnostics - 2 Direct Reports (Research Associates)

-Led quality and compliance of laboratory under ISO 13485:2016 GMP IVD medical device regulations, adhered to quality system (QMS) documents,

-As quality system resource, reached consensus on continuous process improvements, DocuSign management, supplier management,CAPA remediation.

-EHS site coordinator, represent site on global EH&S monthly meetings, greatly improved quality metrics via data collection, reporting 6 years.

-Document record management, fine tune existing standard operating procedures, handle lab equipment maintenance documents, collaborate with external vendors.

-Assist project teams with reagent purchase orders, assessing tissue quality, staining quality, project resources, identify risks and execute countermeasures.

-Conduct new hire and annual Safety training, emergency response team virtual meetings, manage Gensuite EHS data, EPA hazardous waste permit

-Participant in annual audit plans, vendor assessments and contractor qualifications

-Provide cross functional support to clinical, medical affairs and EHS colleagues

Lawrence General Hospital- Lawrence, MA

Manager, HistoPathology CAP Lab January 6, 2013 to August 31, 2016 (3 Direct Reports)

● Operational leader, manager of Anatomic pathology lab, including IHC and cytology.

● Managed quality control measures resulting in 2 very positive CAP audit inspections.

● Purchased lab equipment, trained staff to implement and run 20 new IHC patient assays

● Diagnostic value - added 2.5M revenue/year to hospital by adding new diagnostic testing conducted in house (compared to shipping/testing in CA)

● Provided technical immunohistochemical (IHC) training expertise to Pathology staff.

● Composed new IHC assay (20) SOP’s and CoPath/Sunquest LIMS system standard operating procedures for routine use by staff within Pathology Department.

● Resolved interdepartmental issues, directed laboratory improvements for OSHA compliance, strong medical terminology, relied on previous hospital experience.

● Proficient in MS Office, Co-Path / Sunquest LIMS, Leica equipment

AstraZeneca Pharmaceuticals, Waltham, MA September 2005 – April 2012

Scientist, R & D Translational Science, Discovery Medicine

• Created New Translational Science Biomarker laboratory, AZ dosed clinical specimens, assay validation, patient diagnostics run simultaneously supporting AZ sponsored trials.

* Point of Contact role managing 7 clinical trial projects, IHC biomarker assay validation and patient response stratification supporting Phase 1 drug development.

• Developed, managed patient slide analytics using Aperio slide scanner algorithms.

• Clinical team liaison - interactive data review with pathologist, external clinical team(s).

• Analytical work plan author, biomarker study documents from assay to final reports, summarized data, created project poster and publications.

• Global histopathology steering team member, facilitated monthly remote meetings.

• Global quality team member, updated quality systems documents, protocols, maintained scientific content for clinical publications.

ImmunoGen Inc. Cambridge, MA August 2001- Sept. 2005

Research Lab Manager, Study Director - direct reports (2 research associates)

● Managed, delivered complex Phase I oncology biomarker assay projects from study design through clinical study report under GLP compliance.

● Technical lead - biomarker IHC assay projects, submitted to FDA (immuno-drug conjugate assays) in support of Phase I/II clinical trials

● Wrote standard work, assay development procedures, final GLP reports.

● Authored portions of IND submissions, protocols, reports and regulatory audits associated with drug development under 21 CFR Part 312.

● GLP inspection- lead audit participant GLP with external collaborator(s).

● Quality data- assisted MD pathologist to verify IHC data, final results.

● Trained research associates in specimen processing operations, audit readiness.

● Biobank manager, daily operations, sample quality chain-of-custody, inventory

CytoLogix (acquired by DakoCytomation) Cambridge, MA July 2000- August 2001

Senior Research Associate, R&D Product Development

● Developed and validated 12 new primary antibodies Class 1/11 IVD diagnostics under GMP, 21 CFR Part 820 QSR, on automated IHC slide stainer, ran target validation assays

● Quality Assurance - authored new product specification sheets, instructions for use (IFU), regulatory information, reported diagnostic data for IVD human assay

● Quality Audit Team Member, conducted internal audits, prepared documentation for ISO9001 certification, GMP audit trained, stability data document reviewer

● Authored quality procedures, processed documents, proposed revisions

● Trained sales unit on relevant GMP compliance, pathology logistics, in vitro diagnostics.

● Quality management, author SOP’s, product documentation compliance with FDA/ISO

● Designed scientific literature reviews to support new products, promote clinical utilization

Beth Isreal Deaconess Hospital- Needham, MA June 1999 – July 2000

Manager, Pathology Laboratory Quality Assurance

● Operational leadership of histology workflow and laboratory personnel.

● Managed quality metrics of Histology, Blood Bank and Microbiology Labs.

● Defined CAP audit re-accreditation, assured lab documents met CAP standards.

● Provided technical expertise in histochemical principles for Pathology Department.

● Authored Immunohistochemistry manual utilized within Pathology Department.

● Resolved interdepartmental issues, directed laboratory improvements for OSHA compliance, strong medical terminology, relied on previous hospital experience.

● Proficient in MS Office’98, Medi-tech LIMS

Publications

- A Phase I study to assess the safety, tolerability, and pharmacokinetics of AZD4877,

an Intravenous Eg5 inhibitor in patients with advanced solid tumors. Cancer Chemotherapy and Pharmacology. 2011 Jun 3. Infante JR, Kurzrock R, Spratlin J, Burris HA, Eckhardt SG, Li J, Wu K, Skolnik JM, L. Hylander

- Assessment of CHK1 phosphorylation as a pharmacodynamic biomarker of Chk1 inhibition, Clinical Cancer Research 2011 June 1, 2011 Morgan Meredith, Y. Qian, Maria Gross, Zhao Lili; Parsels Joshua D; Davis Mary, Linda Hylander, D. Simeone, D.Morosini,

- Mechanism of radiosensitization by Chk1/2 Inhibitor AZD7762 Involves Abrogation of the G2 Checkpoint and Inhibition of Homologous Recombinational DNA Repair Cancer Res; 70(12) June 15, 2010 Meredith A. Morgan, Leslie A. Parsels, Lili Zhao, Joshua D. Parsels, Mary A. Davis, Maria C. Hassan, Sankari Arumugarajah, Linda Hylander

- Cytotoxic activity of the maytansinoid immunoconjugate B-B4-DM1 against CD138+ Multiple Myeloma Cells, Blood Journal, Volume 104, Number 12, December 2004.

Pierfrancesco Tassone, Victor S Goldmacher, Paola Neri, Antonella Gozzini, Linda Hylander, K. Anderson et al

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