Project Management Program Manager

Kristan Baker Senior Program Manager

PROFILE STATEMENT – Passionate Transformative Engineering Technical Leader Transformational executive leader with a strong interdisciplinary engineering & capital project/program management expertise with broad technical, strategic, & operational experience. Demonstrated history developing and leading 10-250+million dollar global design engineering, facility/maintenance & construction organizations. Inclusive results-based leader with proven success integrating diverse multinational stakeholders. Skilled in international project management extensive capital engineering in global PMO organizations, large- complex greenfield capital and construction project management, digital transformations, CDMO, technology transfer, NPD, R&D launches, experience across diverse industry and cultural domains (biotech, gene therapy, vaccines, pharmaceutical, semiconductor, aerospace, research, energy & power generation/utilities). My objective is to obtain a challenging technical leadership position where I can play a key role in leading engineering organizations across the globe.

Director/Senior Manager Engineering PMO & Capital Project Engineering experience in global cGMP & diverse regulatory environments as well as client facing (Biotech, Pharmaceuticals, Medical Device, Development Lab’s, Biologics, API/Formulation facilities, Aseptic filling (syringes/vials) packaging processes, etc.

Expertise in 21 CFR Part 11 Computer System Validation/Data Integrity experience. General Aseptic Quality & Validation experience as well as regulated facilities i.e. FDA, DEA, OSHA, and EPA.

Significant Global Team Leader in matrixed organizations responsible for driving results, providing strategic planning and leadership; set priorities for team members to ensure focus initiatives are met

Root Cause/Continuous Improvement/FMEA/LEAN Practitioner/Six Sigma/ Scrum/Agile/PDCA Problem Solving Mindset/ SME for operational, construction & project excellence

Significant design, build, run and maintain function of industrial and automation systems Advanced level expertise to global capital projects including feasibility & concept studies, capital facility build- outs and equipment and system selection and process improvement projects.

Experience in IoT Industry 4.0, big data, smarter manufacturing/smarter transportation/smarter cities/smarter medicine, predictive analytics, etc.

Passion & Knowledge of IoT smarter manufacturing, assets, data as well as understanding of ISA 95, ISA 88, MES, OSI, etc.

Experience in providing technical support to manufacturing facilities.

Experience with different Industrial systems (PLCs, process control systems like DeltaV, OSI/Aspen historians, application/web servers, building management systems, utility systems, lab systems and cross platform communication)

Significant start-up experience

Understanding of emerging IoT and Mobile technologies and communications protocols.

Big Picture “Whole Systems Minded Strategic Thinker”/Smart Leader EDUCATION

MBA, Norwich University 2011

PMP Certified, 2010, PMP No. 1316792

Project Management Certificate, Colorado State University, Denver 2007

MS Bioengineering, Syracuse University 2002

BS Power Engineering, Maine Maritime Academy

PROFESSIONAL EXPERIENCE

Jan 2023 – present Consulting (Director Kneat Services, Engineering & Digital Transformation)

Nov 2021 to Jan 2023 ThermoFisher Scientific Viral Vector Gene Therapy Cambridge MA Head of Cambridge/Somerville Client Program Management Gene/Cell Therapy

July 2019 to Nov 2021 Pfizer, Andover MA

Senior Manager Tech Transfer Gene/Cell Therapy (COVID Plasmids/Drug Substance) Senior Manager Quality Systems PMO – Digital Transformations McPherson, Kansas

March 2019 – July 2019 Data Acuity Systems – AstraZeneca, Maryland Senior PMO Digital Transformation

December 2016 to March 2019 Bayer Animal Health, Shawnee, Kansas Sr Mgr Site Engineering & Technology Project Management Office & Construction

Aug 2015 to December 2016 Pfizer, Kalamazoo, MI

Manager Project Management - Aseptic Filling and Freeze Drying Capital Project Manager

March 2013 to Aug 2015 Intel Corporation, Hillsboro Oregon/Israel/AZ Corporate Capital Construction Project Manager

August 2011 to March 2013 IBM Systems & Integration Group, Inc, Burlington, Vermont Systems Engineer/Program Mgr. -Smart Manufacturing, Smart Building & Energy Initiatives/Fire

November 2009 to August 2011 Goodrich Aerospace, Inc., Vergennes, Vermont Program Manager Bell Helicopter/Boeing Military/Korean Aerospace

October 2007 to Oct 2009 Mylan Technologies/Pharmaceuticals, Inc., St. Alban’s Vermont Senior Manager of Project Engineering & Project Management

May 2005 to October 2007 Amgen Inc., Boulder, Colorado Thousand Oaks, California, Cork, Ireland PMO Capital Project Manager/Principal Automation & Control Systems Engineer

March 2003 to May 2005 Genzyme Corporation, Allston, MA Geel Belgium, Capital Project Automation & Controls Engineer/ Project Manager

July 2000 to Feb 2003 Syracuse University, Welch Allyn Syracuse, New York Graduate Research Assistant /Research Engineer

June 1997 to July 2000 Micron Technology, Inc., Boise, Idaho Control Systems/Electrical Engineer

Jan 2023 – present Consulting VEQTOR

Director Digital Services, Capex Engineering & Digital Transformation

Lead a team of 15+ engineers/project managers on external projects with major pharmaceuticals in the Design & Implementation of Kneat based C&Q/CSA packages (paperless Validation software) & ASTM E2500 risk based C&Q/CSA strategies of manufacturing & utility systems, engineering services, preventative maintenance optimization, and various other business develop activities associated with Digital Transformation in the various high tech industries (semiconductor, biomanufacturing arena, etc.). Nov 2021 to Jan 2023 Thermo Fisher Scientific Viral Vector Gene Therapy Cambridge MA Head of Cambridge/Somerville Client Program Management Gene/Cell Therapy

Reporting to the Site GM & Global PMO Director acts as a functional member of the CAM/Somerville Site Leadership Team.

Provide mentoring, development, and technical oversight/leadership for new and existing client program management teams (6-8 direct reports)

Provide technical oversight, structured planning and execution of a range of programs/projects, functional groups, resources and client related initiatives and activities to enable operational efficiency, strategic growth, communication and technical outcomes. Interactions are extensive within the company and extend to other external clients and collaboration partners. Responsible for setting up a Project Management Office (PMO), creating and distributing PM tools, and ensuring on time delivery/quality for projects and tech transfer activities.

Provides leadership and technical and operational support to the framework, processes and tools that enable drug development program teams to effectively plan, execute and report on TFS VVS’s Gene Therapy drug development/commercial programs from project inception through regulatory submissions/approvals and commercial operations.

Provides expertise and leadership to clinical, regulatory, manufacturing, quality, and alliance partnerships, as well as other internal operations as necessary.

Leads and facilitates cross-functional teams and meetings comprised of both internal and external resources to assist with the development of program tools, playbooks. to review program progress and to ensure on-going alignment across client business entities.

Support client services team in generating proposals, RFPs, study plans and scope of work preparation.

Translate and understand requirements for work performed within a GxP site in order to work with other organizations within the TFS VVS family

Demonstrated expertise and experience with Cell and Gene Therapy approaches, expertise and technology.

Proven experience with portfolio management, portfolio expansion and research/development in an industry setting

Sept 2020 to present Pfizer, Andover MA

Senior Manager Tech Transfer Gene/Cell Therapy (COVID Plasmids)

Provided project leadership and oversight of COVID Plasmid technology transfer and validation of plasmids/biologics drug substance manufacturing and analytical processes. Delivered a 6 mos tech transfer process 4 mos early while simultaneously leading the TT to Orth/Zagreb. Provided oversight for 2 direct reports.

Supported Suite GH facility design, development, implementation, manufacturing & transition from a non- GMP to GMP facility (including execution of a multiproduct risk assessment).

Supported early to late phase clinical trial material as well as the transfer of commercial manufacturing between manufacturing facilities involving internal, partner, and contract manufacturing sites.

Tech Transfer Lead for DMD, COVID Plasmid Transfer from Chesterfield to Andover & Andover to Orth/Zagreb (including upstream/downstream processing & analytical methods)

Led cross-functional teams responsible for the planning and execution of plasmid manufacturing technology transfer, production campaign preparation, facility readiness, process validation, post- campaign product disposition, and development of tech transfer knowledge management playbook.

Assisted in Authoring regulatory submission documents & Validation Strategy for clinical and commercial products

Facilitated GMP manufacturing, and release of clinical and commercial product

Supported health authority inquiries and inspections as applicable

Collaborated and communicated operational readiness/transfer status successfully with key stakeholders

Implemented tracking system/visual management tool for on time closure of CAPAs/QARs July 2019 to Sept 2020t Pfizer, McPherson, Kansas

Senior Manager Quality Systems PMO - Computerized Systems McPherson, Kansas

Senior Manager responsible for day to day functional oversight of master data in key electronic quality systems, quality compliance/data itegrity of master data in critical electronic systems on site (SAP, EAMs, MES, serialization, labeling, artwork, gLIMS, MODA, etc).

Implement continuous process improvement related to defined Digital core electronic systems, Quality systems, GxP databases as required (including the development of data, process, and system flow diagrams).

Build-out of new or transformation of existing Data Management tools or processes including protecting data as an asset (security, compliance, audit, etc.), data quality and governance, central monitoring, data cataloging and reference data or MDM functions.

Partner with Portfolio leadership on Digital IT projects. Ensure effective collaboration with IT to ensure that IT systems are developed and managed in accordance with business and regulatory expectations.

Ensures strong GxP (GLP, GMP, GCP) leadership knowledge of IT Systems and GxP technologies and ensure regulatory applicability and consistent data integrity is applied

Supported FDA & health authority inspections

Coached, mentored, and provided development for 8 direct reports. March 2019 – July 2019 Data Acuity Systems – AstraZeneca, Gaithersburg Maryland Senior PMO Digital Transformation

Development of a Front End Program Plan that included creation of a data lake/data correlation tool that included a BIM 360 3D facility model with all electrical, mechanical, and major buildings & infrastructure identified, creation of an asset performance management system, implementation plan for developing an end-to-end facilities prescriptive maintenance system (AI) to be developed with tools like Iconics, Kepware, and MS-SQL Server.

December 2016 – March 2019 Bayer Animal Health, Shawnee, Kansas Site Engineering & Technology Office –Sr Manager Project Management Office & Construction

Facilitated the development, integration, and coordination of Site Strategy and Execution Plans at the site level to deliver the Site Engineering & Tech-Ops Strategy as part of Engineering Program Management Office (PMO) role. This includes the oversight and overall project management of strategic initiatives associated to global business where applicable as well as Site Master Planning Activities.

Developed and facilitated effective governance structures at the site level and also reporting at the Site and Global level while establishing robust processes to track, analyze and monitor measures of performance across the sites

Managed the day-to-day activities in the Program Management Office (PMO) to ensure Site Engineering & Technology projects are delivered per the contract Scope of Work, and per the professional services contract between Bayer stakeholders.

Implemented and provided guidance to Bayer’s team of Project Managers and Discipline Engineers, related to PMO processes and policies, provided oversight of the work of project management and engineering staff, and works with other department leaders to define, prioritize, and develop projects and programs.

Oversaw project costs across the Shawnee Site project portfolio and makes sure they are well managed through monitoring profit and cost sheets for each project, and ascertains that payment collections are performed efficiently and timely from a project management point of view, thereby ensuring positive cash flow on projects. Develop, implement and maintain an infrastructure of processes, procedures, supporting tools and systems using industry best practices and guidance

Created a comprehensive Project Management guidance document/ PM Playbook

Created and delivered training on Project Management standard work for various project managers and other key stakeholders

Trained, coached and mentored various project managers for improved project management competencies within the US Shawnee Operations

Performed periodic review with the project teams and with management to ensure that phase-gate/ stage- gate criteria are met in the most efficient manner.

Developed the repository of Project Management knowledge, best practices, lessons learned, and resources

Owned processes to support Project Portfolio Management and Project Execution Steering Committees and facilitate regular steering committee meetings to ensure appropriate project prioritization and resourcing

Led and directed all facilities & maintenance construction activities, capital project construction management, & all Bi-annual Project Construction Shutdown Execution Strategy for the Bayer Animal Health site.

Primary liaison between executive management and project management overseeing project planning, scheduling, budgeting, engineering, implementation and construction of new and rehabilitation projects.

Provided oversight of Engineering Change Management & Drawing/CAD Dept. Responsible for implementation of a Site Engineering Change Management system and policies for requirements management, document management, change management, production and delivery, and configuration management of the performance, functional, and physical baselines over the Bayer Animal Health Engineering System life cycle.

Implemented continuous & operational improvements in Capital Project Engineering Lifecycle, Asset Lifecycle Management, equipment health to reduce unplanned asset downtime, increase asset effectiveness, reduce engineering costs and make more informed decisions regarding assets, reliability, failure prediction, and capital utilization.

Aug 2015 to December 2016 Pfizer, Kalamazoo MI

Manager Project Management - Aseptic Filling and Freeze Drying

Leader accountable for establishing a clear vision for their portfolio, building organizational capability, driving execution, and improving operational performance and reliability.

Managed high-impact, highly-critical capital projects supporting update and expansion of aseptic filling and freeze-drying operations at Pfizer's Kalamazoo drug product manufacturing facility. Managing multiple projects on the order of $10M-$100-million.

Served as subject matter expert (SME) for critical aseptic processing with working knowledge of current industry best practices in these areas.

Ensured our aseptic drug processing capital investments utilized the best technology, had the best outcomes for the business, and aligned with contemporary standards.

Lead critical aseptic drug product capital investment scoping initiatives.

Prepared & presented Capital Project Appropriation requests (CPAs).

Interfaces with Pfizer Global Engineering to ensure project compliance with applicable PGM standards, follow all PGM best practices and comply with Pfizer Quality Standards.

Led the Project Engineering organization for site and corporate initiatives.

Ensured a high level of compliance and efficiency to drive the organization to world-class biotechnology manufacturing standards.

Demonstrated expertise in the turnaround of troubled projects and creation of functional, multi-discipline integrated organizations.

Mar 2013 to Aug 2015 Intel, Corporation, Hillsboro Oregon Corporate Capital Construction Project Manager (Wires – Instrumentation & Controls/Life Safety/Electrical/IT):

Provided technical/project management oversight of automation & control, life safety, IT, electrical, process control software design & validation/commissioning effort for new 450mm $1B manufacturing facility in Ocotillo, AZ

Managed programming scope development/cost estimation/design effort for Israel Fab 28 & 28A retrofits -

~2B (IT, I&C, Electrical – $250-300MM)

Provided design oversight of the new technology upgrade for Fabs 12, 22, 32 effort in Ocotillo AZ August 2011 to March 2013 IBM Systems & Integration Group, Inc, Burlington, Vermont Professional Systems Engineer/Program Manager (Smarter Planet Initiatives/Controls/Capital Projects): Smart Grid, Smart Building & Energy, Smart Manufacturing, Fire & Life Safety Program Manager Systems engineer/Program manager supporting local/global IBM deployment of smarter building/city technologies to improve energy and building management, and enhance reliability.

Integrated building systems, infrastructure systems and enterprise systems. (Facilities building automation, electrical power control systems, production (MES systems)

Implemented operational improvements, capital efficiency improvements, quality and reliability improvements, resulting in reduced facility operational and production costs.

Implemented best business practices and policies for BTV.

Provided users with analytics, advanced intelligence, visualization and decision tool capabilities.

Provided Systems Modelling, data-driven analysis using a variety of quantitative analyses.

People Manager responsible for development of junior associate program/project managers November 2009 to August 2011 Goodrich Aerospace, Inc, Vergennes, Vermont Program Manager:

Bell Helicopter V22 Ofsprey/Boeing Military /Korean Aerospace T-50/KTX-1 Program Manager for Fuel Management Systems Production Programs. (DoD, and ITAR regulated environments)

Duties included: primary VOC/focal interface for military aircraft manufacturer’s accounts; direction of Engineering Integrated Product Teams and cross-functional teams; new business; SOWs; bid/no bid decisions; quality control; government proposal/contracts management, negotiation, development and tracking schedules, issue escalation, milestones and budget performance via EVMS; resource management; change control; SME for process improvements.

People Manager responsible for development of junior associate program/project managers and organizational leadership

Manage and integrate production and supply processes to ensure that production objectives are consistently achieved.

Prepare a wide variety of customer, government, and organizational briefings and business unit reviews supporting required business presentations, conference calls, and site visits.

Lead technical direction of program, Best Practices and SharePoint administration, and an enterprise wide software tool used internally and with our customers to ensure accurate program collaboration.

Identified system/ process gaps and mitigated risks to put the KTX-1, T50 and V22 programs on track.

Led Extensive optimization of processes and capacity, directing Continuous Improvement projects, Lean Manufacturing, 5Sconcepts, Problem Solving, FMEA etc. ACHIEVEMENTS

Cost savings in excess of $1,00,000 due to decreased cycle time/reduced rework hours

Improved OTD & customer satisfaction metrics

October 2007 to Oct 2009 Mylan Technologies/Pharmaceuticals, Inc, St. Alban’s Vermont Senior Manager of Project Engineering/Project Management:

People manager of company resources in engineering manager capacity. Developed and managed capital budget totaling up to $8 million in an FDA, NIH, and DEA environment. (8 direct/4 indirect reports)

Oversight and direct management of projects that involved complex schedules whereby carving out solutions, critical paths or scheduling a series of events was vital to successful outcomes.

Provided strategic planning and leadership; set priorities for team members in order to ensure on- budget and on-time deliveries.

Created and/or managed project related documentation including business case, scope of work, risk assessments, schedules, requirements, budgets, roadmaps and status reports.

Completed more than 50 projects for mission critical applications involving clinical trials, ERP, LIMS, DCS, lab renovations, systems and manufacturing.

Experience with initiation, development, and / implementation of NPI, global multifacility NPD, manufacturing expansions, major capital projects including IT, process control, computerized business systems, facilities upgrades.

ACHIEVEMENTS

Created a comprehensive Project Management System (methodology, procedures, templates, databases) to implement, communicate, and report status of projects in a standardized structured manner May 2005 to October 2007 Amgen Inc., Boulder, Colorado Thousand Oaks, California, Cork, Ireland PMO Capital Project Manager/Principal Engineer (Automation & Control Systems/Electrical ):

PMO Capital Project Manager (IT, CUPS, electrical, automation & control systems, process equipment URS/FRS/DDS) for new bulk protein manufacturing and formulation, fill and finish facility construction in Cork, Ireland (~350MM)

Extensive engineering experience in automation & process control design in Biotech facility design and construction. Specializing in design, construction, commissioning and start-up of Biotech, Development Lab’s, API/Formulation facilities, Aseptic filling (syringes/vials) and packaging processes, clean process utilities.

Lead Engineer/Project Manager for new BMS system design and installation for manufacturing facility expansion in Puerto Rico

Lead /Project Manager for Andover Controls Building Management System hardware/software design, installation, and start-up for HVAC controls for hazardous biological labs Thousand Oaks, California

Performed Lead Engineer/Project Manager tasks for facilities/production related projects 25,000ft NPI manufacturing facility expansion (Kepivance, AMG 162, AMG 531) in Boulder, Colorado

Responsible for the managing the activities of major capital projects greater than M$1.0 for the design, engineering, and technical execution of the automation/electrical/I&C/network aspects of corporate/site multidiscipline projects (HVAC, Utilities, Electrical, Network, Automation, Business System) Colorado, Thousand Oaks CA

Laboratory equipment validation: including calibration, SDMS system, BMS systems, multiple PLC's, environmental monitoring systems such as DAS, bioreactors, stability chambers, cold rooms. ACHIEVEMENTS

Cost savings in excess of $500,000 due to green building design, lighting controls, etc. March 2003 to May 2005 Genzyme Corporation, Allston, MA Geel Belgium, Waterford Ireland PMO Project Engineer (Automation & Controls Systems):

Lead Engineer responsible for start-up and commissioning of a DeltaV Process Control Systems for new

$40MM Myozyme Manufacturing Suite in Allston MA.

24/7 PCS DeltaV, PLC, SCADA support for manufacturing facility.

Engineer involved in process control, software/hardware design & validation effort for new cell culture 70,000ft $75MM biopharmaceutical manufacturing facility in Geel, Belgium

Responsible for the process control design (network software and hardware), documentation (generation of URS, FRS, DRS, validation and commissioning protocols), commissioning and validation of biotechnology equipment and processes. Interacted with manufacturing leads, Validation/Tech. Services, QA/QC and site engineering as required.

Setup and managed IT computer validation lab for rapid deployment of software/computer/lab equipment for regulatory standards: (FDA, NIH, DEA, IRK, ICH, and standards such as GAMP4, ISO 9001- 9003 ~ SDLC)

ACHIEVEMENTS

Delivered validated software for all automated process equipment required for a new bulk bio- manufacturing facility before FAT and mechanical/electrical equipment installation. July 2000 to Feb 2003 Syracuse University, Welch Allyn Syracuse, New York Neuroscience Laboratory Control Systems Graduate Research Assistant /Research Engineer

Provided technical support for clinical research studies, including setup and operation of controls, automation, robotics/automated systems, sensors, actuators, motion control systems, laboratory/Medical/ Bio-Medical equipment/instrumentation. Interfaced with Clinical Laboratory doctors in order to respond to their new ideas and/or research grants and subsequently designing and implementing experiments, technical problem solving, developing computer programs and devices for Biomedical research

Research engineer at Welch Allyn working on machine that provides early detection of Alzheimer’s disease.

June 1997 to July 2000 Micron Technology, Inc., Boise, Idaho Control Systems Engineer:

Performed instrumentation and controls/electrical engineering to support Plant Operations, construction, and maintenance groups. Responsible for management/implementation of system design and plant development, which includes the following: process control systems including HVAC system design, Bulk chemical systems, PLC, SCADA, HMI + network system architecture

1995 to 1997 Harutunian Engineering, Inc., Austin, Texas Control Systems/Electrical Engineer:

Responsible for the design and implementation of process-control systems for City of Austin Wastewater, Water, and Power Utilities, and other private industries requiring consulting. 1991 to 1995 - Contract Work

Various contract engineering positions held during college and post-graduation: Babcock Ultrapower Power Generating Station, Chittenden Biosolids Processing Facility, and Four Seasons Environmental.

EXTRACURRICULAR

Education Outreach/Mentoring plus Local PMI Chapter Events

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