Quality Assurance Manager

Wendy A. Linthicum

**** *********** *** ? New Market, MD 21774 ? 301-***-**** (H) ? 301-514-

**** (C) ? ************@***.***

Manufacturing Operations Manager with extensive experience in manufacturing

operations, research and development and implementation of Lean Six Sigma

principles. Proven abilities in cGMP/ISO regulations and guidelines,

product development and technical support resulting in increased customer

satisfaction and retention. Adept at process and productivity improvement,

quality assurance and workflow optimization. Led high performing teams,

trained, mentored and developed team building. Excellent leadership,

creative problem resolution and effective multi-tasking skills.

? Strategic & Tactical Planning ? Performance Management ?

Customer Focused

? P & L Accountability ? Applications Development ? Result

Driven

Technical Skills

Primary Cell Hematopoietic stem cells (include CD34+, CD133+), T cells, B cells, NK

Isolation and cells, monocytes, dendritic cells, hepatocytes, mesenchymal stem cells,

Cell Culture pre-adipocytes, neural progenitors, stromal cells, NPC's, adipose

derived stem cells, osteoclast precursors, and erythroid progenitors

from human and animal sources; insect cells, tumor cell lines

Assays and ELISA, FACS staining, development and production of monoclonal

Techniques antibodies, MTT, immunoassays (natural killer, blastogenesis, IL-1 and

IL-2 production, interferon production, cell stimulating factor),

cytotoxicity assays, colony assays, Western Blots,

immunoprecipitations, gels, dot blots, HPLC, protein

purification/concentration/estimation, viral protein production by

baculovirus system; in vivo cytogenetic studies including chromosomal

aberration, sister chromatid exchanges, micronucleus assays, cell cycle

kinetics, dominant lethal assays, and LD50; Cryopreservation of cells;

radioisotope labeling.

Applications Microsoft Excel, Word, PowerPoint, Access, Documentum, Novamanage, P2

Performance Management, Track-it, Sysaid, SAP, RENCS, Trackwise,

Outlook, e-Time, WordPerfect, Sigma Plot, Kinetic Calc, Chrisma,

Montage slide production

Experience

Lonza Walkersville, Inc. / Cambrex, Inc., Frederick, MD 1999

-2010

Manager, Poietics and Hepatocytes Cell Production / Cells on Demand

(Lonza) 2008-2010

Manager, Hepatocyte Cell Production, Walkersville Site (Cambrex)

2004-2008

Senior Supervisor, Hepatocyte Cell Production, Walkersville Site

(Cambrex) 2000-2004

Lab Manager, Poietics Gaithersburg Site (Cambrex)

1999-2000

Managed up to 7 direct reports, over two shifts and split shifts;

completed annual merit reviews, set and achieved individual and team

goals aligned with corporate initiatives and departmental directives;

hands on manager; provided technical guidance; set production schedules

based upon forecasted sales, actual sales, and inventory levels; product

timelines included same day, 24 hour, and spanned several weeks; chaired

monthly team meetings and weekly lab meetings; conducted market research,

perform cost analysis, created Bills of Materials (BOM), label formats,

Quality Assurance Control Sheets (QACS), Device Master Records (DMR),

Device History Records (DHR), and Standard Operating Procedures (SOP);

completed deviations, Corrective and Preventative Actions (CAPA), attended

Material Review Board (MRB); provided technical support to customers and

managed customers' orders working closely with sales and marketing;

facilitated Pre-Production Quality Assurance (PQA) for new products.

Maintained a cohesive and effective production team through three company

name changes.

. Seamlessly transitioned Gaithersburg site to Walkersville site and

designed a 5S production lab without disruption to production schedules in

2009.

. Received highest performance rating of Top Performer in 2008.

. Eliminated 7 years of backorder in 4 months for Poietics products

produced at the Gaithersburg site.

Lonza Walkersville, Inc. / Cambrex, Inc. (continued)

Maintained zero backorder for the Hepatocyte Production produced products

for 5 years.

. Coordinated multiple departments' efforts to produce standard and custom

products, monitoring process from obtaining raw materials to the delivery

of the finished product.

Recovered ~$490K in available product sales by analyzing failed batch QC

data and identified inaccurate data, facilitated retest.

. Resolved the cell recovery challenge for mobilized PB CD34+ cells to

recover ~250 amps; results equated to ~$213K in sales/batch.

. Increased product ship rate for fresh plated human hepatocyte products

from ~50% to ~90%.

. Increased QC success rate for human neural progenitor cells from ~25% to

100% in 2008.

Successfully completed multiple new product transfers from R&D to

manufacturing.

. Increased batch sizes and batch numbers of products by a minimum of 25%

by improving QC passing rates, analyzing production trends, and

implementing process improvements.

. Reduced batch cost by optimizing processes, standardizing procedures,

reducing labor costs, trouble-shooting, and reviewing standard cost versus

actual cost analysis.

. Reduced discards by implementing in process screenings, utilizing failed

products to produce other products, and setting specifications for failed

products to be offered to a niche market.

Poietics Technologies, Inc., Gaithersburg, MD 1995-1998

Lab Manager

Managed daily lab processes and functions; coordinated services and

productions; developed operating procedures for all products; received and

maintained raw material inventory; monitored levels of cryopreserved

finish product and shipped product; provided customer service and

technical support to clientele, procured cord blood and transported

tissues; involved in marketing and sales; generated reports for clientele.

. Key Player in the launch of the start up company and its

subsequent success.

. Provided technical support for Miltenyi Biotech customers in

exchange for products.

. Developed and implemented process for producing more than one product per

tissue, resulting in labor reduction, while maximizing output.

. Purified CD34+ progenitors and other hematopoietic cell types from cord

blood, fetal liver, bone marrow, and peripheral blood from human and

animal sources using magnetic bead isolation techniques.

. Performed colony assays, hematopoietic assays, lineage Marker

Assays (ELISA).

. Screened compounds in vitro and assessed proliferative and

differentiative effects upon progenitor cells.

Otsuka America Pharmaceutical, Inc., Rockville, MD 1992-

1995

Research Associate II

Procured and purified CD34+ progenitor cells from cord blood, fetal liver,

bone marrow, and peripheral blood. Performed hematopoietic assays,

developed methods to direct lineage differentiation and proliferation,

screened compounds in vitro and assessed proliferative and differentiative

effects upon human progenitor cells. ELISA's (cytokine production and

lineage marker), MTT assays, and Immunofluorescence staining of cells for

flow cytometry. Developed and produced monoclonal antibodies. Served as

alternate chairperson and member of the animal care and use committee.

. Optimized Lineage Marker Assay.

. Developed method for producing hematopoietic intermediate precursors,

resulted in average of 100-fold increase in cell numbers.

. Provided technical data and potential source of issue to R&D Systems to

assist resolving extreme variation in R&D Systems cytokine assay kit

results.

Advance Bioscience Laboratories, Frederick, MD

1990-1992

Sr. Research Technician

Performed all aspects of the development, production, purification,

characterization, and cryopreservation of monoclonal antibodies.

Characterization techniques of monoclonal antibodies included protein

gels, western blots, Dot Blots, ELISA's, and immunoprecipitations.

Produced virus and viral proteins utilizing the Baculovirus system.

. Developed and characterized functional monoclonal antibodies to HIV

reverse transcriptase.

Additional Experience

Biological Research Faculty and Facility, Ijamsville, MD

Research Technician

Developed and produced monoclonal antibodies. Characterized

monoclonal antibodies utilizing ELISA

and Dot blotting techniques. Performed HPLC purification,

concentration, and protein estimations of

monoclonal antibodies. Managed animal facility (mice, rats,

hamsters).

American Biotechnology Company/Theracel, Rockville, MD

Research Assistant

In vivo and in vitro drug screening assays; immunological assays; co-

managed the animal facility (mice and rats).

. Optimized primary assay process, reducing labor by 75%.

Microbiological Associates, Bethesda, MD

Lead Biological/Animal Tech

Coordinated in vivo cytogenetic studies; produced S-9 product, performed

quality control assays, bone marrow harvest and preparation, surgical

subcutaneous implants, chromosomal preparation, slide smears and staining.

Managed Genetic Toxicology portion of the animal facility (mice, rats,

hamsters). Supervised and trained lower level personnel in SOP's and

GLP's.

. Designed color coded system to facilitate dosing schedules and

minimize error for animal dosing studies.

. Streamlined S9 production process, reducing labor by 50 % per batch.

Program Resources, Inc., Frederick, MD

Biological Laboratory Technician II

Established, maintained and cryopreserved in vivo and in vitro human and

murine tumor cell lines from cryopreserved lines and fresh resections.

Performed various tumor genetic studies including cell titrations,

immunological studies, drug dose response, and developed in vivo

metastatic models.

. Volunteered for lead on special projects, including managing projects

for thirteen NCI/NIH investigators.

Education

University of Maryland Baltimore County, Baltimore, MD, Training

Certificates in cGMP's, Quality Control & Quality Assurance for Biotech

Products, Facility Design, and Regulatory Affairs

Johns Hopkins University, Baltimore, MD, Master of Science,

Biotechnology, GPA 3.67/4.00

Hood College, Frederick, MD, Biomedical Sciences Coursework, 24 credits

University of Maryland, College Park, MD, Bachelor of Science, Animal

Sciences, GPA Major, 3.51 /4.00

Additional Training, Certifications, and Nominations

AALAS Certified Animal Technician Hazardous Material Coordinator

Targeted Selection Six Sigma Supervisors Training

Strategies for Success P2 Performance Management

Managing Multiple Projects/Objectives/Deadlines Preventing Workplace Harassment

How to Become a Better Communicator Careful Communication

Business Writing Basics for Professionals Lean Manufacturing Principles

Nominated for Team of the Quarter Blood Borne Pathogen Training,

Annual

CITI course: Protection of human research cGMP/ISO Training, Annual

subjects, Annual

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