Project Manager Management

Cheryl Lynn Hanna

**** ****** *****, ***** ******, CA 93063 805-***-**** acz4e8@r.postjobfree.com

Objective

I am a motivated and hardworking Biologist looking for full time employment in the life and/or analytical sciences. I have over twelve years of experience in the biopharmaceutical industry, can lift more than 50 lbs, am athletic (no physical restrictions), and am fluent on all Microsoft Office programs.

Experience

SPECIALIST, SENIOR ASSOCIATE AMGEN, INC. AUGUST 2005 – OCTOBER 2015

Lead GMP Cell Bank Operator and New Product Introduction (NPI) Project Manager

Aseptic technique, Environmental Monitoring (Environmental and Personnel), cell culture assay specialist.

Collaboration with client groups for cell line, process development and manufacturing in a manufacturing/biopharmaceutical environment

Operation, maintenance and troubleshooting of standard and specialized cell culture analytical and laboratory equipment

Authored and reviewed controlled documents (Standard Operating Procedures, Manufacturing Procedures, Product Specifications, Technical Reports)

Departmental Safety Representative

Technology Development: Conducted independent assays to test and qualify the implementation of novel processes and new equipment.

SENIOR ASSOCIATE, ASSOCIATE AMGEN, INC. MARCH 2003 – AUGUST 2005

Authored/Reviewed controlled documents (Standard Operating Procedures, Manufacturing Procedures, Product Specifications, Technical Reports)

Routine cellular diagnostic testing and process improvement strategist

Lead GMP Operator, and Shift Lead – Commercial Manufacturing

Scale-up of cell culture from cryovial to large scale bioreactors for production of commercial drug product

Skills & Abilities

PROCESS

Processes and Systems

Aseptic technique; Environmental, Personnel, DI and WFI Sterile Sampling (Environmental and Personnel sampling with TSA RODAC and STA TSA plates); Cryopreservation; Chinese Hamster Ovarian (CHO) and E. coli cell culture operations; Buffer and Media making; Project Management; MS Office and Projects Proficient; Validation; SAP; EDMQ, EDM Teams; Laboratory Inventory Management Systems (LIMS); Trackwise System for Change Control Management and Nonconformance Systems, Contract Laboratory sample coordination; Electronic Laboratory Notebooks (ELN) systems

Equipment

Environmental monitoring systems (Slit to Agar R2S and Total Air Particulate); Standard and inverted Microscopy; Bioreactors; LAF Hoods; Centrifugation; Spectrophotometry; pH Meter; Osmolality; Blood Gas Analyzer (BGA) and NOVA diagnostics; Shake and spin platforms; CO2 Incubators; LN2 freezers; Autoclave; Benchtop and floor scales; Filter Integrity Testing (FIT)

Communication and Collaboration

Collaboration with client groups (Quality Control, Process Development, Regulatory)

Critical thinking, science based, problem solving; Strong interpersonal and communication skills

Project Management and coordination of GMP cell culture processes in a high volume manufacturing laboratory

Education

BS DEC 2002 CAL STATE UNIVERSITY AT NORTHRIDGE

Major: Microbiology, Minor: Chemistry

Interests

In my free time I enjoy hiking, camping, gardening, furthering my knowledge with podcasts and reading.

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