Chris Mansur Email and Phone Number

Accountable for the growth and financial performance of the Consulting Service Line. Developed nationwide growth strategy and supporting infrastructure including a Operations playbook/manual with business processes, KPIs, and maturity models. Increased Revenue 89% over 3 years from 29.6MM to 56.0MM through the opening of 10 new offices. Increased Operating Profit 147% over 3 years from 6.4MM to 15.7MM. Hired, managed, and developed new Directors in support of business and personal growth. Developed new fixed prices services for GMP Roadmapping, Auditing, and Documents on-Demand. Supported the transfer of Service Line leadership in early 2023.

Initiated intra Service Line collaboration with 5 Consulting Offices to enable crowd solving and global business processes. Initiated inter Service Line collaborations with Azzur Labs and Cleanrooms On-Demand to improve cross-selling. Supported Corporate initiatives including development of a new Sales Org. and Shared Services model.

Founded Boston Consulting Office in 2013 and initiated in-market hiring and business development. Grew Revenue over 5 year period to > 10MM. Developed additional Calibration Service Line with A2LA accreditation and 1.5MM in Revenue. Supported the transfer of Office leadership in 2018/2019.

1. Managed restart & revalidation of 2 API plants (after 2+ years in “moth-balls”) using new ASTM-E-2500 (risk-based) approach and new FDA/EU Guidance on Process Validation for < 5% of capital project costs.2. Managed relocation and requalification of 75+ analytical instruments as part of QC Lab Relocation Project.3. Created (or revamped) the following programs (1) Process-level failure mode, effects, and criticality analysis (FMECA) (2) Process monitoring (3) Periodic cleaning monitoring (4) Revalidation/Periodic review. 4. Oversaw key validation activities at aseptic filling CMO and supported FDA filings and follow-up inspectional questions/responses.5. Revised cleaning validation program to be risk-based, leverage visual residue limits (VRLs) and visual clean baselines, and generated cleaning validation master plan to improve facility inspection readiness.6. Generated Corp. Validation Master Plan (VMP) and presentations to improve facility inspection readiness. 7. Presented Validation program to EMA inspector in July 2012 with zero (0) validation-related observations.8. Generate high-level dashboards and detailed Gantt charts for launch of two (2) commercial products in the US, EU, Russia, and South Africa. Facilitate team meetings and provide updates directly to the CEO.

1. Supported the following major Process and Cleaning Validation projects:• Process Validation execution for Replagal AF, including authoring of the PV&E section of the eCTD.• Process Validation protocol preparation and execution for Velaglucerase Alfa.• Tech Transfer of HNS from development to the multi-product facility.2. Supported the following major Computerized and Lab Systems Validation projects:• PQ of the Ross ERP System and numerous Operational upgrades and Functionality expansions.• Install of an Amega Scientific Central Monitoring System for all Warehousing and Labs.• Core Upgrade of Infor Enterprise Asset Management (EAM) system including addition of Cal / E-Sig.• Install of Empower 2 CDAS, TrackWise QMS, and ValGenesis Validation Management System.3. Revamped CSV Policy to include GAMP 5 principles including increased use of Supplier Documentation.4. Co-managed backlog reduction team which eliminated 50+ open validation projects in 2.5 months.

1. Established new functional area responsible for manufacturing-related computerized systems.2. Managed automation change control in support of 15+ Automation Engineers to fixed cycle time metrics.3. Reduced closeout cycle time for shutdown projects by 83% (from 235 days to 40 days) during 2005.4. Reduced closeout cycle time for revalidation by 42% (from 40 days to 23 days) during 2006.5. Co-Site lead on 2 Corp. Policies rewrite teams, Facility & Equipment Design & Compute System Validation

Quality team lead for the Qualified Building Management System (QBMS), a site wide automated HVAC Control and Monitoring System (including the daily oversight of three (3) Quality specialists).

1. Developed GAMP4-based procedures for validation of automated systems (e.g. URS Generation, Deviation).2. Primary Quality resource for review of manufacturing systems validation documentation for the Phase IV Expansion Project (added 330,000 sq. ft. to the existing Commercial Mfg. facility of 270,000 sq. ft).3. Member of Team charged with establishing a Corporate GMP Manufacturing Start-up Guideline.4. Team Leader of the Qualification Summary Report Standards Team for BioPharma Division (three sites).

Primary author of English documentation on a Cleaning Validation Project team assembled to resolve an FDA Warning Letter in preparation for an August 2000 follow-up inspection. Authored FDA Correspondences, Validation Final Reports, Position Papers, and established Routine Monitoring Program. Position Papers Set Process-Based and Toxicity Based Acceptance Criteria.

1. Responsible for supporting capital projects and day-to-day validation maintenance needs at 3 facilities; blood collection and separation, blood purification, and chromatography in-house media manufacturing. Support areas included Facilities, Systems, and Equipment, Cleaning, Process, and Computerized Systems.2. Create internal Validation Database and Project Tracking System to manage projects and assigned staff task and facilities weekly validation team meetings.3. Generated internal validation protocol templates for individual tests for equipment IQ and OQ.4. Generated 12+ internal Validation SOPs from scratch, prior to arrival only 2 existed.

Provided Validation Services for 5 Biotechnology and 2 Medical Device Companies; highlights listed below.3M MEDICAL TECHNOLOGIES, Hinsdale, IL – Project Lead• Evaluated Quality Systems and presented findings to Corporate Validation Manager and Plant Manager.• Supervised 3-person validation team to generate/implement Validation Project Plan for Heart Monitoring Electrode Machines with PLC Controls. Implemented Process and Computer Change Control Systems.TELECTRONICS PACING SYSTEMS, Miami Lakes, FL – Sr. Validation Engineer• Generated/Implemented Validation Protocols for Vacuum Furnace with Honeywell PLC, Sterile Packaging Line Machinery, and Reflow Solder Furnace and Resistance Welding System.SERONO, Bari, Italy - Validation Engineer• Generated/Implemented Validation Protocols for new fully automated BOSCH Filling Line.