Kaitlin Perkins Email & Phone Number

Raleigh, Nc, Us

• Project manager for all downstream CAPAs to update MBR and SOPs. Created a CAPA tracker via MS Excel to ensure timely closing of all tasks. • Authored and updated downstream MBR for commercial batches.• Evaluate employee performance and set goals for seven direct reports each quarter.• Provide work schedules to employees and communicate necessary departmental information.• Organize training and professional development opportunities for direct reports.• Collaborate with human resources department to identify, interview, and hire employees.• Ensure manufacturing plan of record is met by coaching, monitoring, and enforcingsystems, policies, and procedures.• Delegate tasks to employees and provide feedback regularly on their performance.

Sanford, North Carolina, United States

• Organized fermenter media soiling activities in support of Train 2 ManufacturingCommercialization Project.• Authored buffer MBRs and reviewed process batch records in preparation fornew clinical campaign. • Implemented a project to streamline small buffer preparations in Purification,reducing prep cycle times and material movement within the manufacturing area.• Oversaw manufacturing activities during clinical trial material campaign and providedimmediate quality and procedural support for upstream and downstream processes.• Investigated deviations and implemented CAPAs as needed within manufacturing.• Participated on multiple interview panels for various roles in commercialand clinical trial manufacturing areas.

Fermentation and Purification Process Engineer (July 2020-May 2021)● Collaborate with validation and other support groups on a weekly basis.● Assist in troubleshooting automation issues in DeltaV ● Revised 16 manufacturing SOPs for business continuity and commitment needs.● Performed root-cause analysis with cross-functional teams and identified corrective actions to implement continuous improvement projects. ● Qualified on all manufacturing operations for downstream and upstream processes.● Helped lead purification team during process validation runs to prioritize processing needs vs. business value added tasks. Cleaning and Shipping Validation Associate (January 2020-July 2020)● Assisted in the execution of a cleaning validation protocol for process support.● Contemporized a shipping validation platform and authored shipping lane characterization forms.● Performed gap analysis on cell bank shipping for audit preparation.Validation Engineering Associate (July 2019-December 2019)● Authored and performed a process steaming qualification for autoclaves on site.● Performed an Environmental Mapping Technical Study within the Gene Therapy unit.● Updated Master Validation Protocols to be compliant with current validation standards.

New Jersey

• Developed a process to improve governance of existing customer shelf life policy• Assisted in the development of a formal Shelf Life Policy with new exception approval criteria• Analyzed customer shipment data and quantified a cost of $340K to manage shelf life exceptions with opportunities for cost reduction• Facilitated cross-functional collaboration and developed a project tracker tool to improve team synergies

Raleigh-Durham, North Carolina Area

• Led 3 on-campus events and outreach efforts to increase brand and product awareness with a team of fellow REAL Ambassadors• Created weekly, on-trend, lifestyle-related social media posts and content on priority social channels (Instagram, Snapchat, + Facebook)• Acted as a student influencer and ongoing advocate of the Aerie brand and #AerieREAL mission • Promoted and shared feedback about latest product offerings.

Raleigh-Durham, North Carolina Area

•Preside as a teaching assistant for a Research Methods course•Assist students in learning the fundamentals of research•Answer questions concerning engineering applications•Lead engineering based activities•Provide a welcoming environment for all students to learn

Jacksonville, Florida Area

Analyzed manufacturing line data using Minitab software (i.e. capability and performance analysis reports).Managed a feasibility protocol for supplier qualifications.Collaborated with R&D for business continuity and cost improvement projects.Produced silicone hydrogel lenses in a glove box for use in raw material (OQ/PQ) qualifications.

• Developed programming goals for regional K-12 STEM outreach activities • Planned the 3-day Region II PCI Mini-conference • Served on the National PCI Committee and supported national initiatives• Supported and monitored Collegiate and NSBE Jr. Chapter PCI activities • A Walk for Education volunteer

Raleigh-Durham, North Carolina Area

Participating in Dr.Thomas LaBean's DNA Origami Research Lab, researching DNA nano-structures for molecular computation, templated assembly, and biological applications.• Request lab equipment or supplies necessary for the project• Manage and respond to project related email• Attend lab seminars and other meetings as necessary• Calculated dilution of DNA strands to improve lab efficiency• Knowledgeable of lab safety and procedures

Raleigh-Durham, North Carolina Area

•First Aid/CPR/AED Certified•Assisted 21 incoming freshman become better acclimated to campus life andstressed value of good study habits•Directed and supervised new students throughout daily activities•Clearly articulated NC State safety rules and process all students must followto have a safe and successful transition to campus•Accountable for personally mentoring 5 students

1. Serve as the leader of the Programs Zone.2. Develop and implement innovative programs consistent with the National and Regional directives of the organization3. Coordinate and administer National and Regional Programs.4. Prepare reports on regional programming statistics.5. Assisted the chapter in receiving "2015-2016 National Chapter of the Year" and "Regional 2015-2016 Chapter Retention Program of the Year"

•First Aid/CPR/AED Certified•Assisted 36 incoming freshman become better acclimated to campus life andstressed value of good study habits•Directed and supervised new students throughout daily activities•Clearly articulated NC State safety rules and process all students must followto have a safe and successful transition to campus•Accountable for mentoring 4 students personally

Moyock, North Carolina

• Assemble, maintain, and operate technical (recording/audio) equipment• Record sermons for transfer to local radio station• Managed packing and delivery of CD’s to church patrons• Learned how to handle complaints and resolve issues• Maintained financial contributions generated by CD sales