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Work Background
American Apprentices WorkBusiness Skills Coach
Feb. 2024Accountability Partner - Supporting apprentices in managing their apprenticeship
commitments on a weekly, monthly, and quarterly basis. Guiding apprentices to help them troubleshoot challenges, problem-solve, and effectively navigate their learning journey in alignment with the structured apprenticeship curriculum and program. Skills Coach for Personal and Professional Development - Support apprentices in applying their business skills modules, encourage apprentices to reflect on and contextualize their learning experiences, and building apprentice confidence to integrate these new skills into real-world practice. Facilitator of Formal Assessment Process - Lead monthly check-in sessions with apprentice and their workplace mentor to review apprentice progress in achieving overall competency and meeting apprenticeship learning objectives.
Kati Lynne Small Business Solutions, LLCFounder
Nov. 2023Design shapes how people perceive value, fostering trust and loyalty. A thoughtfully designed business doesn't simply run efficiently; it looks and feels cohesive, aligning visual identity with operational excellence. From the way a brand communicates through its visual language to the seamlessness of its customer interactions, every detail counts. Coaching & Consulting
Business operation coaching and consulting services that utilize human-centered design to uncover the root causes of operational challenges, identify areas of opportunity, and deliver solutions that are both impactful and sustainable. Design & Organization
Business organization and design services that utilize human-centered design to transform how your business operates and presents itself, ensuring every aspect of the company is thoughtfully crafted with the end user in mind.
BerkadiaSenior Project Manager
Jan. 2023 - Jul. 2023Ambler, Pennsylvania, United StatesCo-led the stand-up of the Project Management Office (PMO) for the 2022 aggregation of HR, L&D, and Culture departments into one People Organization. Objectives were to:
1.) Aggregate, streamline, and optimize ways of working.
2.) Create visibility and enable collaboration across projects and teams.
3.) Enhance the ability to notify, communicate, and report on human-centered driven metrics. Developed, designed, and built the monday.com infrastructure, a digital project management tool to facilitate the operationalization and reporting.
Provided training and coaching and developed guides to aid project leads in project management acumen and skills.
BerkadiaSenior Implementation Partner, Corporate Culture
Aug. 2022 - Jan. 2023Ambler, Pennsylvania, United StatesLeverage a human-centered design approach to support behavioral changes and new ways of working critical to successful cultural transformation.
MerckLEAD Ally Co-Lead
Jan. 2022 - Jul. 2022Co-LEADing the strategy development and execution for the compilation, organization, and creation of resources to ignite as an active, committed, and inclusive community, and to generating a culture that embraces, rather than avoids, discomfort in our differences.
MerckDesign Thinking Innovation Enablement
Apr. 2020 - Jul. 2022Design Thinking | Lead facilitation for the development of impactful solutions, strategies, and results for complex business challenges. imagineU | Inception, development, and implementation of imagineU School of Design Thinking, a 3-course training experience that delivers human-centered problem solving skills and tools to individual contributors and organizations across the enterprise through experiential and interactive learning.
MerckAssociate Director Strategic Planning
Apr. 2020 - Jul. 2022Providing leadership, project management, and facilitation for business areas to develop impactful solutions, strategies, and results for complex business challenges.
MerckDesign Thinking Facilitator - imagine@merck
Jul. 2019 - Apr. 2020Support imagine@Merck’s Innovation Workshops through leading and co-facilitating Design Thinking workshops and expanding its reach through training new facilitators locally and globally.
Development GMP RoundtableCo-Chair 2019 Development GMP Roundtable
Oct. 2018 - Sep. 2019As the conference co-chair, led a steering committee for industry benchmarking, and led the successful preparation, planning, and execution of the annual Development GMP Roundtable. Preparation & Planning:
Defined roles and responsibilities for Steering Committee representatives from twelve (12) pharmaceutical companies.
Restructured and combined the two existing committees to decrease meetings, break down silos, and create a more cohesive committee and event.
Implemented a new conference planning structure in effort to distribute ownership and actions. Event:
Three (3) speakers and thirty-seven (37) benchmarking sessions over two (2) days
Attended by ~90 participants (Target 70) from ~15 companies. Event survey results represented ~75% of attendees, reporting that ~96% of agree (~60% strongly agree) that they would recommend the event to a colleague, and that ~88% agreed the sessions addressed their needs/concerns.
MerckCo-Chair/Founder Merck Sport and Social
Jan. 2018 - Jul. 2022Merck Sport & Social provides a platform for the promotion of health, wellness, and social connectedness, while expanding employee engagement, productivity, and retention through the experience of unity, connection, and cohesiveness.
MerckAssociate Director Quality Assurance
Jan. 2018 - Apr. 2020West Point, PAProject Lead and key quality team member for diverse and complex projects involving process and compliance improvements, new technologies and products, and new ways of working. Directly supports team and stakeholders through consultation, issue resolution, and batch release both locally and globally. Clinical Supplies Quality lead in designing, developing, and implementing an accelerated manufacturing and packaging process by integrating the manufacture, testing, packaging, and release of early phase clinical drugs. Key team member in the development of a comprehensive overview for the operational and regulatory components necessary to enable future readiness in the manufacture of personalized medicines.
Development GMP RoundtableSteering Committee Member
Jun. 2017 - Apr. 2020Coordinate responses for intercompany benchmarking questions and support the Development GMP Roundtable planning and execution through content development and compilation.
MerckSenior Specialist Quality Assurance - Global Clinical Supplies
Feb. 2016 - Jan. 2018West Point, PAProvided local and global support for the release of Clinical Finished Goods through the review of clinical labels, regulatory filing requirements, and batch documentation. Authored, reviewed, and approved Standard Operating Procedures. Key quality team member for the implementation of process and compliance improvements, support for internal and regulatory audits, and the development and performance of onboarding and training for new employees.
WuXi AppTecQuality Assurance Project Lead - Manufacturing
Jun. 2015 - Jan. 2016Philadelphia, PAQuality Manufacturing Project Lead
Provided end-to-end quality oversight, support, and approval for the onboarding, development, and GMP execution of new Cell and Gene Therapy projects. Onboarded the company’s first autologous CAR-T immunotherapy, mitigating the end-to-end risks of cross contamination and mix-up.
WuXi AppTecSenior Specialist Quality Assurance – Cell Banking & Cell/Gene Therapy Manufacturing
Mar. 2014 - Jun. 2015Philadelphia, PASenior Specialist Quality Assurance – Cell Banking & Cell/Gene Therapy Manufacturing
Performed batch disposition for Cell Banking and Cell/Gene Therapy manufacturing, reviewed and approved Master Batch Records, and authored, reviewed, and approved Standard Operating Procedures. Provided quality support for internal, external, client, and regulatory audits, onboarded and trained new employees, and supported Testing record reviews, as needed.
Key quality team member for the implementation of process and compliance improvements. Quality Manufacturing Department Lead
Managed the tracking, scheduling, and delegation of work, created department metrics for leadership, and lead weekly department meetings. Training Coordinator
Developed a new onboarding and training prioritization for new employees and ensured department training was current. Activities Committee Member Planned, coordinated, and executed activities for philanthropy and company events.
WuXi AppTecQuality Assurance Specialist - Cell Banking & Cell Therapy Manufacturing
Feb. 2013 - Mar. 2014Philadelphia, PAPerformed batch disposition for Cell Banking and Cell/ Therapy manufacturing, reviewed and approved Master Batch Records, reviewed product labels, and authored, reviewed, and approved Standard Operating Procedures. Provided quality support for internal, external, client, and regulatory audits, onboarded and trained new employees, and supported Testing record reviews, as needed.
WuXi AppTec, Inc.Quality Assurance Specialist - Testing
Nov. 2012 - Feb. 2013Philadelphia, PAPerform testing record review for GLP and GMP biologic, molecular, and viral testing.
Mastery Charter SchoolsAssociate Instructor – Science & Mathematics (Middle Years)
Aug. 2012 - Nov. 2012Greater Philadelphia AreaTrained with Philadelphia Teaching Fellows for overall lesson plan creation and classroom management. At Mastery Charter School - Hardy Williams, instructed three 8th Grade General Science courses and one 9th Grade Algebra I course.
WuXi AppTecLaboratory Technician
Sep. 2011 - Jun. 2012Philadelphia, PAManaged, performed, and tracked completion of required routine and non-routine environmental monitoring, incubation of samples, and sample reading for approximately twenty (20) Manufacturing Biological Safety Cabinets (BSC), twenty-five (25) Manufacturing rooms, and sixty (60) Testing BSCs. Revised department Standard Operating Procedures and compiled and generated metrics for sample result data.
Sanofi PasteurManufacturing Technician II
Aug. 2010 - Sep. 2011Swiftwater, PAAccountable for the successful and compliant performance of conjugation and supporting processes for production of the Menactra vaccine. Performed routine environmental monitoring of the conjugation production suites. Principal Investigator: During decreased manufacturing, was flexed to perform investigations and write deviation reports for procedural and process deviations
Sanofi PasteurEnvironmental Monitoring Technician
Aug. 2009 - Aug. 2010Swiftwater, PAManaged, performed, and tracked completion of required routine and non-routine environmental monitoring and data entry and completed daily room release for Building 46 production suites.
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