Leanne Kramer Email & Phone Number

Durham, Nc, Us

Billingham, Gb

Morrisville, North Carolina, Us

- Assisted in the start-up and operational launch of a new process development site in North Carolina, ensuring alignment with FDA cGMP regulations, company objectives, and budgetary constraints.- Utilized Kepner-Tregoe analysis to identify and resolve recurring two-month-long contaminations, enabling the process development team to restore normal operations within one week by securing new raw materials.- Led a cross-functional collaboration with an international partner to pilot cutting-edge electroporation equipment, ensuring compliance with FDA regulatory standards and facilitating comprehensive training that enhanced operational readiness and project outcomes.- Led scale-up and transition from static culture to spin bioreactor, identifying appropriate vendor and vessel, and created sheer force calculator.- Developed a robust process database to support Monte-Carlo simulations, patent filings, and data-driven decision-making, significantly improving CRISPR/Cas9 editing efficiency and ensuring adherence to quality and regulatory requirements.- Mentored and guided junior scientists in designing studies that met stringent regulatory and patent filing requirements, contributing to the successful advancement of key projects and the professional growth of the team.

Morrisville, North Carolina, Us

- Spearheaded cross-functional communication with the Operational Readiness team and senior leadership, ensuring a seamless transition into the role of interim process development lead.- Executed meticulous project management, maintaining accurate timelines for IND targets for two platforms, and led critical studies, ensuring timely completion of all tasks.- Aligned project activities with key milestones and deliverables, demonstrating organizational skills and driving projects to successful outcomes.- Mentored team members through company transitions, ensuring smooth adaptation to new processes and procedures, and maintaining high levels of team support and professionalism.- Fostered a positive and cohesive team environment, enhancing team confidence and promoting growth among team members.

Durham, North Carolina, Us

- Co-designed a novel cell cooling/mixing device, performed FAT at the device manufacturer site, and SAT in process development lab and manufacturing suites.- Utilized process and product FMEA methodologies to identify and mitigate risks, ensuring high-quality outcomes for two critical processes.- Prepared and reviewed technical and regulatory documents, including IND sections, Electronic Lab - Notebook entries, batch records, work instructions, SOPs, and technical reports, ensuring compliance and accuracy.- Led the design and successful Technology Transfer of a groundbreaking cell freezing process, increasing process yield and manufacturing flexibility, and developed associated batch records, work instructions, and bill of materials for implementation.

Durham, North Carolina, Us

- Drove IND-enabling studies for multiple programs to completion, demonstrating leadership and expertise in guiding critical research and development efforts.- Led optimization initiatives for non-target cell depletion and cell cryopreservation, enhancing process efficiency and product quality.- Trained manufacturing associates and new employees on diverse unit operations, effectively transferring knowledge and fostering a skilled workforce.- Utilized Kepner-Tregoe analysis to identify root causes behind process-related challenges, enabling timely and effective problem-solving.

Pasadena, California, Us

- Proficient in RNA isolation, cDNA synthesis, and qPCR techniques for gene expression analysis. Utilized Taqman assay and endogenous controls to accurately assess target gene expression levels compared to a control group.- Led the development of a solid phase binding assay using Integrin αVβ3 to quantify RGD motifs. Although the assay was ultimately discarded, demonstrated skills in assay development and optimization.- Conducted RNA isolation and cDNA synthesis from animal tissue and Hepatitis B virus samples, ensuring high-quality nucleic acid extraction and preparation.- Played a crucial role in maintaining cell lines and ensuring general laboratory upkeep, contributing to a well-functioning research environment.- Implemented a Styrofoam recycling and disposal protocol, showcasing commitment to sustainable practices and environmental stewardship.- Organized laboratory chemical and supply inventory in an easily accessible document, streamlining inventory management processes and promoting laboratory efficiency.

Madison, Wi, Us

- Demonstrated leadership and support as a valuable resource for members of the WISE community, providing guidance and assistance to promote their professional growth and success.- Took the initiative to organize and coordinate a variety of outings and activities with the floor, fostering a sense of camaraderie and engagement among team members. Designed both educational and enjoyable events, enhancing team collaboration and morale.- Displayed effective communication skills by facilitating open and productive interactions within the WISE community, ensuring clear and efficient exchange of information and ideas.