Karen Bernards Email & Phone Number

Bothell, Washington, United States

• Standardized processes among programs, creating templates for vendor selection, minutes, action and decision logs, budgets, Smartsheets (timelines as well as dashboards) and folder structure and organization within.
• Support multiple cross-functional technical product teams in developing and implementing CMC and supply chain strategies at all stages of the program for both small molecule and biologics programs.
• Work closely with Technical Product Lead (TPL), coordinating and synchronizing technical activities, planning meeting agendas and providing minutes, identifying risks and mitigation strategies, and ensuring milestones.
• Develop and manage integrated timelines, working closely with CMOs and SMEs to support Technical Product Teams (TPTs), CMC, supply chain, regulatory and Global Product Teams (GPTs).
• Play critical role in the CMC interface with finance for long range planning (LRP), budget, PO and budget tracking and accrual management for multiple projects.
• Identify and communicate risks and issues that impact quality, compliance, project timelines, resource requirements, finances or the overall business relationship.

Seattle, Washington, United States

• Conduct cross functional team meetings and managing CMC team activities via agenda, minutes, and project information for four active programs (3 small molecule and 1 biologic).
• Communicate to senior management and key stakeholders of project status as well as escalating issues when they impact timeline
• Create and maintain timelines, scenario planning and budgets for all CMC programs
• Support regulatory submission readiness by coordinating drafting, review and QC of IND sections

Bothell, WA

• Responsible for ensuring active communication of status, risk, risk management, and escalation of issues to stakeholders and management.
• Create and maintain timelines and budgets of the CMC project plan and ensure that the functional resources and timelines are aligned with overall development program timelines for a Phase I antibody
• Analyze critical path, evaluate potential means to accelerate pace or mitigate identified risks and plan contingencies with input from various functions
• Serve as liaison with vendors and manage day-to-day communications
• Organize project team meetings, prepare meeting agenda, minutes and follow up on action items
• Hold team members accountable to their deliverables on schedule

Bothell, Washington

• Support a wide variety of program management duties within GMP pharmaceutical operations. Work cross-functionally with all levels and departments including research, process development, manufacturing, supply chain.
• Responsible for creating, monitoring and revising project documentation
• Track CMC project deliverables for BLA filing
• Facilitate, schedule, and coordinate interdepartmental meetings as needed to problem solve and achieve designated goals related to BLA filing
• Escalate points of concern to management for further follow up and resolution

Bothell, Washington

• Clinical Supply Specialist August 2016 – July 2018Planning and management of global clinical supply operations and logistics for phase 3 clinical trials.
• Planning and execution of clinical packaging projects, including oversight of production of labels and kitting of clinical trial supplies
• Coordinate and track shipments to depots and clinical sites, with on-demand shipping of IP to clinical sites
• Unblinded for phase III clinical trials, performing 100% drug accountability, and ensuring that IP and Placebo logs are maintained in the pharmacy binder and updated in real time.
• Provide staff training to uCRAs on IP receipt, storage and IP accountability logs
• Review of Pharmacy Manual for accuracy in regards to IP destruction, accountability logs, receipt, storage and temperature excursions.

Greater Seattle Area

• Responsible for project management and coordination within the Therapeutic Cell Production Core (TCPC), including scheduling of clinical cGMP CAR-T cell products and support activities
• Point of contact with external collaborating organizations regarding scheduling new patients/products, document transfer, product availability and shipment of clinical products to sites.
• Capacity planning and production planning for cell therapy manufacturing
• Establish communication tools, protocols, manuals for collaborating clinical sites
• Manage billing efforts for internal and external collaborators
• Coordinated efforts for cost recovery program, resulting in the approval from the FDA

Redmond, WA

• Responsible for project management, coordination between groups, scheduling of study and resources, ordering reagents/supplies, data analysis, data delivery and client interfacing for OncoPanel 240TM (large scale tumor.
• Oversight of quality control ensuring data is of the highest quality and meets internal standards. Address and resolve operational issues as they arise. Lead weekly operational meetings with agenda providing status.
• Initiated and implemented several process improvements to the Oncopanel 240TM platform which resulted in cost savings and a reduction in FTE time including optimized seeding densities for the OncoPanel 240 long term.
• Responsible for coordination and negotiation of legal license agreements between vendors and Eurofins legal department for expansion of OncoPanel from 250 cell lines to over 500 cell lines.
• Responsible for pricing oncology assays, updating weekly revenue and KPI reports, and writing SOP’s and assay protocols.
• Extensive experience in cytotoxicity assays using high content analysis in over 300 human tumor cell lines to evaluate cell proliferation, apoptosis and cell cycle.

Bothell, WA

• Study director both ion channels and cytotoxicity platforms including coordination and scheduling of cell culture, reagent prep, compound preparation and client interfacing.
• Developed toxicity assays using primary human cells identifying mitochondrial toxicity, oxidative stress, lipid accumulation, apoptosis, and cell proliferation using HCA approach in 384 well microtiter plates.
• Extensive cell culture experience with 300 different cancer cell lines
• Developed cardiotoxicity assays using hESC-cardiomyocytes to evaluated cardiac toxicity biomarkers using Luminex-100 and High Content Analysis approaches
• Study Director with hands-on experience in the Ion channel inhibition assays (hERG, Nav1.5, Kv1.3) using automated patch clamp technique (PatchXpress). Conducted laboratory procedures according to GLP guidelines.

Mukilteo, WA

• Responsible for array service work including RNA isolation, bioanalyzing samples, cDNA synthesis, in vitro transcription, preparation of labeled targets, hybridization to microarrays, and data extraction.
• Assay development in drug discovery on electrochemically modified compounds for antibacterial activity using various target organisms. Maintain HEK 293 cells, human transformed fibroblasts, and human fibroblasts.
• Tested and updated Quality Control Data that increased production yield. Coordinate with the QC Manager to facilitate rapid turn-around-time for customer orders. Reviewed quality control data to support customer.
• Writing, revising, and reviewing QC Standard Operating Procedures.
• Develop and optimize re-use of microarrays for fluorescent and electrochemical detection. Provide training for the use and reuse of microarrays to customers and distributors.
• Accurately document analytical results and observations, analyze data, and interpret results for the transition of standard grid to platinum grid microarrays. Maintain a complete, accurate, and precise laboratory.

Greater Seattle Area

• Performed in vivo and in vitro studies to determine efficacy of vaccines for leishmaniasis and tuberculosis testing various antigens for immunogenicity and protective ability in the mouse model.
• Tested for TH1 immune responses in leishmaniasis characterized by in vitro lymphocyte proliferation (3H proliferation assays), gamma interferon production (mouse and human cytokine ELISAs), and immunoglobulin G2A.
• ELISPOT assays including isolation of CD4 and CD8 T-cells from mouse splenocytes stimulated with antigens.
• Multi-color FACS and intracellular staining on mouse splenocytes
• Validation of ELISA assays and training for transfer to GMP facility
• General lab organization, ordering of supplies and reagents, and upkeep of freezer database. Provide leadership in animal training, immunology, and laboratory techniques for post-docs and other technicians in the.