Kristin Gekko, EIT

• Ensure site compliance with CGMP regulations, guidance, and industry standards • Review and approve quality events including deviations, and CAPAs • Review and approve qualification/validation documents such as SIA, DIDQ, URS, IQ, PQ, VSR • Review executed Batch Production Records for completeness and accuracy • Responsible for the authoring, review and approval and archival of controlled documentation including but not limited to Policies, SOPs, Work Instructions, Quality Records, Validation documents, and other controlled document types

•Manage the development and training of a manufacturing team of 10+ chemists to achieve fast-paced profit goals. •Responsible for opening and closing shifts of the facilities for manufacturing groups, ensuring safe and efficient working environments. •Writes and reviews deviations, CAPAs, NCMRs, SOPs, and change controls within MasterControl. Reviews BPRs to ensure cGMP compliance and coordinates with QA to get product released to customers. •Oversees lab inventory and procures purchase requisitions for lab supplies to prevent production delays. •Provides on-floor support for troubleshooting equipment including analytical HPLC, TFF skid, AKTA process, BPG column packing.

• Work in phosphorodiamidate Morpholino oligomer purification • Follows approved GMP manufacturing directions such as master batch records and standard operating procedures • Operates equipment for manufacturing and in-process testing such as HPLC systems, lyophilizers, tangential flow filtration skids, and ion exchange purification instruments • Follows and maintains GMP documentation • Initiates and coordinates with QA to write deviations, CAPAs, investigations, and reports • Responsible for training new employees on SOPs, equipment and operations • Provides supervisor support with Batch Record auditing and troubleshooting equipment issues on the lab floor • Experienced in working in a clean room environment (ISO 7 & ISO 8 classified rooms)

• Analyzes water and soil samples by qualitative and quantitative analyses to provide information on present compounds • Uses EZChrom, Chromeleon, Chromquest, XCalibur, and MagIC Net software to generate and evaluate data • Follows standard operating procedures and quality control standards • Works with IC, GC and HPLC/MS instrumentation • Records and purchases neat standards and reagents

Assisting with autoclaving glassware, as well as preparing buffers to be used in the lab. Preparing agarose gels and buffer solutions Assisting with picking cell colonies

Assisted with closing of the library, check-in, check-out, renew materials. Assisted patrons with using various online databases including ROGER, Circuit, and MELVYL systems. Re-shelved items, shift books, shelf-read, and sweep library materials.

Provided instruction to children ranging from grade 2 through 8. Helped out with homework, provided review worksheets and worked through problem sets. Taught new techniques for solving difficult problems. Also helped out with grading and filing.