Quality Control Data Analysis

DANA MIRANDA

*** **** ***, ******* ** ***** 206-***-**** ********@*****.***

SUMMARY

Experienced researcher with ten years of biotechnology experience. Areas of expertise include ELISA, PK, cell-based bioassay, assay development and assay validation. Looking to expand current skillset, learn new techniques and platforms. Proven ability to multi-task and meet project related deadlines head on.

EDUCATION

University of New Mexico

B.S Biology 2000 -2004

[Areas of Concentration: Immunology, Biochemistry]

[Minor: Chemistry]

EXPERIENCE

ZymoGenetics (Bristol-Myers Squibb) Seattle WA

Quality Control Associate (Quality Control Bioanalytics) 2013-Current

Adhere to GMP guidelines

Support Bristol-Myers Squibb’s clinical and commercial programs

Sample analysis for stability and release lots

Equipment qualification and validation

Provide cell culture support for various cell lines including primary cells

Assay qualification

Execution of assay transfers, transfer reports and methods

Perform bioanalytical and chemistry methods in a Quality Control environment

Sample receipt and reconciliation

Scientific writing (Deviations, CAPA’s, method revisions, annual and quarterly evaluations)

Data analysis and troubleshooting

Equipment maintenance

FDA audits

Amgen (Temporary Contract Employee Lancaster Laboratories) Seattle WA

Senior Scientist (Functional Biocharacterization) 2013

Cell culture and reagent preparation

Perform cell based assays: cytotoxicity (antibody and complement dependent), proliferation, potency

Collaborate with various groups providing support for project needs

Sample analysis

Support production timelines

Assay development

Data analysis

ZymoGenetics (Bristol-Myers Squibb) Seattle WA

Research Associate (Bioanalytical Sciences) 2005-2012

Adhere to GLP guidelines

Support Bristol-Myers Squibb clinical programs

Assay development (ELISA, PK, cell-based bioassay)

Assay qualification and full validation

Scientific writing (SOP’s, methods, research reports, validation reports)

Data analysis and summary

Method transfer to contract labs

Equipment maintenance

Cell culture

Sample receipt and reconciliation of clinical patient samples

Reagent preparation

Data analysis and summary

Troubleshooting and problem solving

Training of personnel

Sample analysis (non-clinical, clinical and post approval studies)

In-house audits for clinical programs

Work under tight timelines and prioritize resources to support project goals

Heavy collaboration with other areas of the organization

PROFESSIONAL PROFILE

Highly motivated team player that is adept at working independently as well as contributing and collaborating with others

Detail oriented with 10 years of biotechnology experience

Large scientific background including research, development and analytical sciences

Exceptional oral and written communication skills

Excellent multi-tasking and organizational proficiency

Enjoy troubleshooting and problem solving

Well-versed working in regulatory environments (GLP, GMP and BSL2 level)

Strong regulatory background

Enjoy challenges and learning new techniques

SYSTEMS

32 KARAT

GEN5

DAS

TRACKWISE

MAXIMO

LIMS

ELN

KC4

SOFTMAX

ADDITIONAL TRAINING

American Association of Pharmaceutical Scientists (AAPS) Immunology Conference Course

(2009)

American Association of Pharmaceutical Scientists (AAPS) Cell-based assays Conference Course (2009)

American Association of Pharmaceutical Scientists (AAPS) Advanced Immunogenicity training course (2012)

LANGUAGES

English-native language

Spanish-basic competence

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