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KAREN AHERNE
Phone: 240-429-3890 Email:[email protected]
PROFESSIONAL E XPERIENCE
MEDIMMUNE, INC.
2009-Present
PROJECT MANAGEMENT ASSOCIATE
 Manage 15 member CMC team for immuno-oncology co-development and commercialization project
o Lead both internal and external CMC meetings, including facilitating logistics, lifecycle management,
supply chain, agenda, meeting minutes and follow-up
o Work cross functionally with CMC members to organize project activities to optimize delivery of
strategy within project timelines. Activities include upstream cell line evaluation strategy, forecast
strategy planning, finance strategy, and understanding legal contract and QA filings
o Created and continually update risk register to proactively mitigate risk and optimize problem
solving and decision making within team
 Lead OPAL Simplification Initiative (Planisware project management software for Organizational Process
Assets)
o Reduced OPAL template by ~50% line items by working with functional leads to create new cycle 3
platform template true to actual business strategy and timelines
o Received MedImmune Bronze Award for important accomplishments above & beyond normal job
duties with measurable business impact beyond functional area for improvements to OPAL template
CMC ANALYTICAL REPRESENTATIVE
 Represent Analytical Biotechnology functions at late stage CMC level
o Manage the transfer of analytical methods to contract manufacturing organizations, including analyst
training, assay validation, and documentation
o Coordinate sample plans, testing, storing, and shipping between sites for process performance
qualification, comparability
o Additional responsibilities include reference standard management, scheduling stability protocols,
setting specifications and updates
BIOASSAY DEVELOPMENT ANALYST
 Develop, optimize, and qualify cell based potency assays for release and stability testing, with a focus on
late stage projects to create robust, QC friendly assays without sacrificing scientific quality
 Experience with both proliferation and apoptosis assay development, ADCC reporter gene assay, virus
cytotoxicity assay
 Author and review SOPs, development reports, qualification reports, transfer protocols, and technology
transfer reports
 Routinely carry out project timelines and distribute assay training and sample loads to analysts in group
 Received multiple MedImmune Director’s Awards for recognition for contributions and performance
which clearly exceed expectations
TRAINING AND SUPERVISOR ROLES
 Lead specialist in training and transfer of bioassay methods for both in-house and cross-site activities.
o Train analysts from both GMP and manufacturing sites to become experts in bioassay methods,
including reagent inventory and qualification, cell culture techniques, pipetting, assay performance,
data analysis, and trouble shooting
o Organize and execute transfer strategy and timeline: training memo, analyst method training,
material transfer, technology transfer protocol, technology transfer activity, technology transfer
report
o Oversee facilities, equipment, materials, and software in receiving laboratory
o Received MedImmune Silver Award for significant contributions above & beyond normal job duties
with measurable impact on broad organizational-wide business goals for assay transfer work
 Laboratory move lead coordinator
o Facilitated overall strategy and scheduling for physical laboratory relocation, planned strategic
blueprint of equipment layout to maximize capacity, delegated actions between team representatives
o Activities include freezer reorganization and content distribution, collection and organization of lab
inventory, liaison with facilities for unit calibration, BMS hookups, construction, electrical work,
coordination with moving company and instrument vendors, team lead through move week
LABORATORY INVENTORY AND MANAGEMENT
 Created overall strategy for acquiring new inventory of critical reagents used by a variety of groups and
locations
o Conducted vendor analysis, evaluation of cell culture and assay performance, secured new lot
acquisition, coordinated storage and purchasing options across groups and locations, authored
qualification report
 Introduced new electronic cell bank management system for cell storage and retrieval
o Worked with a team to design and test system prior to roll out
o Acted as team spokesperson and presented department tutorial of new software and applications
E DUCATION
UNIVERSITY COLLEGE DUBLIN, Dublin, IRE
July 2008 – October 2009
Master’s Degree (M.S.) in Chemistry and Chemical Biology
Cross-disciplinary collaboration with Centre for BioNano Interactions (CBNI) and UCD veterinary
medicine.
PRINCETON UNIVERSITY, Princeton, NJ
August 2004 – June 2008
Bachelor of Science in Engineering Degree (B.S.E.): Chemical Engineering (CheE)
Certificate in Engineering Biology
ACADEMIC LABORATORY EXPERIENCE
UNIVERSITY COLLEGE DUBLIN, Dublin, IRE
 Designed independent research project developing an in vitro model of the rat blood brain barrier to
study transcytosis of nanoparticles as a means for drug delivery
 Analyzed data documented in Master’s thesis
 Taught first year chemistry laboratory class as a graduate demonstrator
PRINCETON UNIVERSITY, Princeton, NJ
 Devised and completed thesis research project investigating the stress response of E. Coli to unnatural
amino acid incorporation for scalable protein synthesis
 Composed a publication-caliber thesis
ACTIVITIES AND ACCOLADES
VARSITY INDOOR AND OUTDOOR TRACK AND FIELD TEAMS
 First-Team All-Ivy
 Selected to represent Princeton University in two international competitions in China
INTERESTS AND HOBBIES

Traveling, running, cycling, skiing, cooking, crossword puzzles