Merrick M. Endejann

*** ******* ******* ****

Chapel Hill, NC 27517

Home 336-***-****

Email acyyz5@r.postjobfree.com

Selected Highlights

Directly managed validation professionals engaged in the completion of validation activities.

Developed validation programs, including applicable Master Plans, policies, procedures, and templates.

Hands on experience with regulatory agency, customer, and internal audits.

Able to manage and mentor multiple validation resources and projects, including contractors, budgets, and timelines.

Strong understanding of validation (cleaning, process, and computerized system validation and equipment, facility, and utility qualification) and other validation relevant documents.

Competent in review and audit of documentation packages (protocols, drawings, procedures) for adherence to internal procedures and policies and regulatory expectations.

Experienced in design, development, and enhancement of numerous quality systems, including calibration, document control, investigations, CAPA, and auditing.

14 years direct validation experience with 7 years of management of direct validation FTEs and contractors (9 years overall management experience).

Argos Therapeutics

Durham, North Carolina

Senior Validation Manager, 01/2017 to Current

Developed, and managed a validation budget of $2.8 MM to support validation program activities.

Oversaw a direct staff of 3 validation professionals and managed 8.

Selected to lead the multi-departmental team focused on the commissioning, qualification, and validation activities to support a planned $45-60 MM commercial manufacturing facility. Activities completed to date included development and approval of specifications and several qualification protocols which integrated commissioning tests.

Validation Manager, 01/2015 to 01/2017

Continue leadership of day-to-day and mid to long term planning directives of the Validation program, focused primarily on equipment, facility, utility, and computerized systems.

Created computerized system validation program (including spreadsheets) based upon GAMP 5 and risk based validation programs. Program included specific procedures and templates intended to efficiently generate, maintain, execute, and summarize validation documents.

Teamed with internal and external resources in the design and planned implementation of a new green-field manufacturing facility being built in preparation of commercialization of autologous immunotherapies. Responsible for the qualification effort of new systems and modifications made to existing global computerized systems impacted by facility implementation. Developed schedule, budget, and staffing estimates to meet BLA filing timelines.

Transitioning the scale of the validation program to match company’s transition from clinical material supplier to commercial manufacturer in preparation of PAI readiness for new commercial facility.

Teamed with contractors and internal resources to deliver the successful validation of new ERP (SAP) implementation, CMMS (ProCal) implementation, and upgrade to existing EDMS (MasterControl) using a risk based approach.

Validation Lead, 07/2013 to 01/2015

Responsible for all commissioning and validation activities within 2 existing facility locations used for development, testing, and manufacture of clinical products.

Implemented a robust validation program through SOP and template development and training.

Directly managed 1 FTE, with additional resources provided through consultants or internal resources.

Developed and/or revised all validation related procedures and templates to support manufacture of clinical product (Phase 1 through 3). Procedures and templates included URS/FRS/DS development, validation periodic reviews, protocol deviations, equipment/facility/utility qualification (which includes IOQ protocol template), portable equipment assessments, and chamber mapping requirements.

Performed supplier audit for depot/storage facility and responsible for managing validation deliverables.

Created qualification procedures for simple equipment, reducing review and approval time by > 5 weeks.

Discovered issues with manufacturing equipment and led the subsequent remediation effort to the equipment which saw a 48% increase in yield and 73% increase in doses for administration.

Merrick M. Endejann (continued)

M Consulting, LLC

High Point, North Carolina

Managing Partner, 02/2011 to 12/2013

Grew company in total revenue by > 150% in 2012 and > 55% in 2013 over previous year’s revenue.

Developed detailed quotes for validation and quality system projects for customers engaged in manufacture of products which fall under GMP, GLP and GTP regulations.

Write, execute, and summarize qualification protocols for regenerative cell manufacturing equipment including incubators (CO2, humidity, and temperature), refrigerators, freezers, ultra low freezers, cryogenic storage systems, and control rate freezers.

Performed qualification activities including procedure development and training of Kaye ValProbe (GE Sensing) data logging system.

Generated customer requested documents including a quality plan, calibration and validation policies.

Oversaw the completion of the validation of the NextDocs document control/management system.

Work conducted in various environments including ISO Class 7 and 8.

Banner Pharmacaps

High Point, North Carolina

Validation Manager / Group Leader, 02/2010 to 04/2013

Responsible for 6 full-time employees and all procedures related to equipment, facility, and utility qualification, process and cleaning validation, and computerized system validation including the hiring and training of multiple associates in process and cleaning validation within the NC facility.

Responsible for the SVMP at the High Point, NC facility.

Continued to develop, execute and summarize PVs, CVs, and CSV protocols as well as IQ/OQ/PQs for equipment (production and laboratory), utility, and facility qualifications.

Performed various activities related to new Allen Bradley / RS Batch manufacturing system including protocol development, execution, and summary of CSV protocols.

Oversaw the successful introduction of a new cleaning detergent to production through CV activities for manual cleaning processes.

Led the commissioning, qualification and subsequent CV efforts for 2 COP parts washers.

Responsible for validation review and approval of all proposed change requests at the NC facility.

Managed the qualification and validation activities for facility expansion of a new processing suite and modifications to an existing facility for use with hormonal and potent compounds at the NC site, as well as Canadian manufacturing site.

Assisted in the completion of multiple green-belt projects which saved the company annually $250,000.

Provided review and approvals of batch records for more than 200+ commercialized products and numerous records for developmental and scale up batches manufactured for clinical studies.

Led the complete re-write of multiple cleaning procedures for multiple production departments to improve effectiveness of cleaning activities.

Led monthly training sessions with R&D, QC, and operations representatives on cleaning topics.

Assisted in the completion of FMEA process for existing processes in support of FDA presentation.

Validation Engineer, 08/2007 to 02/2010

Implemented the use of URS, FR, and DS documents in support of new systems and for modifications made to existing systems through procedure development and classroom training.

Identified and implemented improvements in process and cleaning validation and equipment, facility, and utility qualification templates that improved efficiencies in drafting, approving, and executing, while maintaining GMP compliance. Incorporated test scripts specific for hybrid systems (CSV) within equipment, facility, and utility qualification template.

Established minimum requirements for chamber mappings and was responsible for the purchase, qualification, and SOP development for a Kaye ValProbe (GE Sensing) wireless data logger system.

Created, executed, and summarized remediation qualification protocols for manufacturing equipment.

Teamed with others in the development of a periodic review procedure and accompanying template that ensured continued review of each validated system.

Led qualification effort on various laboratory systems. Efforts ranged from review of vendor supplied protocols, through development, testing, and summary of protocols.

Responsible for reviewing and approving proposed change request for equipment, utility, facility, process, cleaning, specifications, and methods.

Merrick M. Endejann (continued)

QualPak, LLC

Laurinburg, North Carolina

Validation Manager, 01/2007 to 08/2007

Developed an entry-level associate into a self-sufficient validation associate responsible for protocol execution, summary report generation, and minor qualification protocol development.

Continued protocol development, execution, and reporting responsibilities in all validation areas.

Headed the effort of aligning 2 site’s Process VMPs to include contract manufacturer requirements and new Process Validation approaches, and process equivalency.

Created 3 site-specific equivalency documents related to batching and filling processes. Assisted in the generation of a corporate level chemical equivalency document. These equivalency documents were used to reduce process validation requirements from 5 formulas to 1 formula for each of the 3 batching tanks and 2 packaging lines. Without these documents, 25 individual PV protocols were required.

Revised all non-utility system VMPs to include all completed commissioning, qualification, validation (process and cleaning) activities, and to align with new PVMP requirements related to the bracketing approach for packaging and equivalency document creation.

Teamed with engineering and maintenance in the development of a corporate calibration program.

Implemented a bracketing approach for PVs that evaluated specific parameters to determine when full PV was necessary and when Process Confirmation protocols would be necessary.

Validation Engineer, 02/2005 to 01/2007

Executed all CV studies for batching and storage tanks, transfer piping, transitory equipment, product totes, raw material eduction equipment and liquid fillers. Completed all CV activities including limit calculations, validation protocols, and assisted in execution activities for a new worst-case formula introduced to the facility.

Created and implemented a corporate change control program that was used to maintain systems which included system impact and component criticality assessment processes.

Investigated non-conformances and process deviations to determine proper resolution including water quality, batch yield discrepancy, raw material non-conformances, and out of specification conditions.

Created, trained, and revised all master batch records for batching operations as well as development and revision of supporting SOPs.

Lead all qualification activities for the site, including new batching tanks, COP parts washer, changes to the existing water system, and continuous operation machine (wipes machine). Water system changes included the addition of polishing beds, double pass RO system, constant ozone sanitization process, and changes for completing all CIP final rinses with ozonated water. Utilized integrated approach to qualify continuous operation machine which reduced approval timeframe following commissioning activities.

Lockwood Greene Engineers

Cincinnati, Ohio

Validation Engineer, 04/2004 to 02/2005

Developed and executed IQ/OQ/PQ protocols for various clients including Pfizer (Kalamazoo, MI and Franklin, OH), Cincinnati Children’s Hospital Medical Center, Indiana University Medical Center, and GOJO Industries / QualPak, LLC (Laurinburg, NC).

Managed the activities and personnel responsible for commissioning and qualification activities related to new batch manufacturing process. Qualification activities utilized an integrated approach which used commissioning documents and change control to supplement qualification testing. Sequence testing included 6 CIP and 7 transfer sequences which permutated into 55+ variations.

Performed project management and validation duties for a new 280 BPM liquid filling and packaging line. Responsibilities included development of all Functional Requirements, Traceability Matrices, Factory Acceptance Tests, SOPs, and associated change notices.

Lead the commissioning and qualification activities for a high purity water generation, storage, and distribution system which included carbon beds, fixed D/I beds, and Ozone generation system. Responsibilities included overseeing the qualification of the system, and creation of all supporting documentation including SOPs for operation, instrument calibration, maintenance, and monitoring.

Merrick M. Endejann (continued)

Lockwood Greene Engineers

(continued)

Validation Associate, 08/2002 to 04/2004

Recognized by a client as the validation leader of a new packaging line installation. Responsibilities included writing and execution of IOQ and PQ protocols, and assisting on the completion of the project’s VMP. PM duties included overseeing the completion of qualification documentation created by team members, client review and approval of SOPs, and budget management.

Provided engineering support for the integration and debugging of a two-station reject system installed on a new filling and packaging line for an OTC product. Responsibilities included re-engineering the method of rejection, documenting and testing of all critical functions to ensure proper orientation. Documentation development included the drafting of all SOPs for the reject system as well as IOQ protocol. Additionally, wrote and/or executed qualification protocols for a rotary labeler, bundler, and packout system.

Assisted in the development and execution of qualification protocols for miscellaneous laboratory equipment and utilities including bio-safety cabinets, incubators, centrifuges, refrigerators, freezers, and ultra-low freezers. Utilities included liquid Nitrogen, Carbon Dioxide, and Oxygen storage and delivery.

Created URS, FRS, and DS, FAT and SATs for a new 550 vials per minute labeling and packaging line with multiple OCR visions systems.

Fidelity Investments

Covington, Kentucky

Quality Assurance Manager, 2002

Managed 8 FTEs who worked to support 24/7 operations that oversaw the production of statements on 20 machines which produced an average of 3,000 statements an hour.

Recognized as lead for all procedure revisions, training, and internal audits for 2 departments.

Developed statistical process controls which assisted in disposition of production runs.

Teamed with the members of the QC department to develop and conduct procedural audits. Additionally, teamed with operations to recommend changes based on the results of those audits.

Operations Manager, 2000 to 2002

Reduced staffing from 17 to 13 FTEs through process improvements and redefining job responsibilities.

Aided in development of an Oracle database saving more than $500,000 per year by reducing data entry and increasing productivity.

Worked with Quality Assurance staff to create Access database queries to assist in the reconciliation of postage frees and statement processing quantities upon the completion of all production runs.

Developed a Kanban system which reduced inventory by more than 120 unique part numbers resulting in greater inventory accuracy that was more sensitive to fluctuations in production levels.

Education

1996 to 2001, University of Cincinnati

Bachelor of Science Industrial Engineering

Computer Skills

Microsoft products including Word, Excel, PowerPoint, Access, Project, and Visio as well experiences with TrackWise, LiveLink, NextDocs, MasterControl, Kaye Validator and ValProbe, MadgeTech Secure, SAP, PRMS, VisualBasic, and MiniTab.

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