Project Manager Pilot Plant

W**** Highview Drive Appleton, WI ****** T 510-***-**** E ****@*****.**

Mark Szumowski

Mark Szumowski has been a dynamic force in Project Management and the Architectural profession for thirty years. His recent experiences with Kite Pharma, Novartis, Bayer HealthCare Pharmaceuticals and CropScience, gave him the opportunity to build on his expertise in the areas of Research and Development labs, Master Planning, cGMP manufacturing spaces for OSD and biologics. He has managed the construction of new production areas for Bayer Heathcare and CropScience as well as Novartis (Chiron) while fulfilling users needs and managing project budgets, as well as tight schedules to fit within corporate level goals and directives.

Prior to being the Owner’s Representative for Chiron / Novartis, Mark was the Corporate Architect for the new headquarters of ALZA Corporation, a leading pharmaceutical company located in Silicon Valley. In addition, Mark also led the design and management efforts at Gensler for major retail clients such as Nike and The Disney Stores. These efforts culminated with the completion of Gensler’s first Pacific Rim retail projects in Hong Kong and Shanghai.

Mark’s strengths lie in his commitment to his clients, rock solid technical ability, and his goal–oriented approach to solving problems.

Recent Responsibilities:

! Management Activities: Assembled and coordinated project teams of up to 30 people

! Project Planning: Scheduling of project milestones and collateral project impacts

! Construction Management: Submittal review, milestone coordination & cost controls

! IT Infrastructure: Installation management and system coordination

! Programming and Space Planning: Evaluation of users wants and needs

! Move Planning and Coordination: Orchestration of campus migration plans

! Funding Package Preparation: Budget development, capital costs & expenditure timing

! Design and Construction Team Procurement and Management: Design Team RFP’s and contract negotiation

! Project Planning: Scheduling of project milestones and collateral project impacts

! Management of Hazardous Material Abatement

! Validation and Startup: Coordination of GMP projects with internal groups

! Change Management: Critical change requests, Release For Use documentation, FDA filing support

! Construction Management: Submittal review, milestone coordination & cost controls

! Project Close-out: Punch list, permit and final payment resolution Representative Projects:

Kite Pharma, Emeryville/El Segundo, CA - Linesight 2019 – Present

! RM Project – Expansion of existing manufacturing facility. IOS 8 GMP facility being expanded to improve throughput. $80.6 MM budget

! Site expansion project – a six phase remodeling project to expand the research labs, vivarium, office spaces and lab support functions to accommodate head count growth and the streamlining of operations. $ 40.2 MM budget

! Protein Sciences lab remodel, converting under-utilized area into a lab supporting the expanded operation.

Novartis, San Carlos, CA 2017 – 2019

! Shutdown Planning and Implementation

! Seismic Upgrade Planning

! Various Relocation and Improvement Projects

W3863 Highview Drive Appleton, WI 549153 T 510-***-**** E ****@*****.** Presidio Trust/Letterman Digital Arts Center, San Francisco, CA 2016 – 2017

! Dragoneer Investment Group – Tenant Improvement

! Park Presidio Capital – Tenant Improvement

! En Point – Tenant Improvement

Bayer CropScience, West Sacramento, CA 2014 – 2016

! R&D Greenhouse complex

! Pilot plant

! Phase 4 Office expansion

Bayer HealthCare Pharmaceuticals, Berkeley, CA 2013 – 2014

! Campus Master Planning support

! CAFM evaluation and URS development

! Lab URS development

Bayer HealthCare Pharmaceuticals, Emeryville, CA 2010 – 2011 Senior Project Manager

! ESE Remodeling Projects:

B50 relocation project

Critical equipment seismic anchorage

Reconfiguring of various labs

Break Room Deck Enclosure - Schematic Design and budgeting Bayer HealthCare Pharmaceuticals, Emeryville, CA (Formerly Novartis) 2007 – 2009 Senior Project Manager

! CMF & PDU Upgrade Projects:

Building seismic upgrade for business continuity

Remodeling of GMP areas

MEP systems seismic upgrade

Plan construction phasing around user needs and validation time lines

! Seismic Upgrade Study – P & V Buildings:

Building seismic upgrade for business continuity

Novartis, Emeryville, CA (Formerly Chiron Corporation) 2001 – 2008 Senior Project Manager

! Tech Services Upgrade Projects:

Remodel of existing glass wash and reagent prep areas to improve compliance and replace aging equipment

Plan construction phasing around user needs and validation time lines 3,500 square feet, three sites, $5.2 MM budget

! Oral Dosage Pilot Plant:

Class 100,000 GMP suite for production of Clinical Phase I & II materials for tablets, capsules, and liquid formulations

Integration of existing oral dose process equipment for containment isolators 960 square feet, $3.2 MM budget

! Chemical Development Laboratory: Seattle site

GLP class space for the development of chemical compounds Six bench-top and one walk-in fume hood and supporting spaces for HPLC’s 1,200 square feet, $1.5MM budget

! Final Isolation Suite: Seattle site

Class 100,000 GMP space with a containment isolator for drying, sieving, and packaging of API Construction of space was executed within ongoing chemical development operations W3863 Highview Drive Appleton, WI 549153 T 510-***-**** E ****@*****.** 380 square feet, $2.1 MM budget

! CMF Formulation Suite and Gowning Improvements:

Class 10,000 GMP space with class 100 LAF’s for open manipulations, process util.: WFI, NI, CA 615 square feet, $2.1 MM budget

! PDU Inoculation Suite:

Class 10,000 GMP space with class 100 LAF’s for open manipulations, process utilities including PW, CS, PS, VA, CA, 02, CW, and a new transfer line Construction of the space executed during a three-week manufacturing shut down 320 square feet, $1MM budget

! N2 Oral Dosage Pilot Plant:

Class 100,000 GMP space designed for development work and Clinical Phase II processes for a Oral Formulations, a new science at Chiron

960 square feet, $1MM budget

ALZA Corporation, Mountain View, CA 1998 – 2001

Senior Corporate Architect

! ALZA Plaza

Design Management for the new corporate headquarters from user programming to schematic design and thru final occupancy

Main Building Amenities: 140-seat auditorium, cafeteria and servery for 320, executive and boardroom areas, video conference area

Move planning to facilitate corporate migration of 800 people from Palo Alto to new headquarters Three buildings, four floors each, 360,000 square feet, 8 acres covered parking, $100MM budget Chiron Corporation, Emeryville, CA 1994 – 1998

Senior Project Manager

! Various projects: Remodel and seismic upgrade, Building O - 76,000 square feet, $2.7 MM Diagnostics NAD Labs, Building D - 3,300 square feet, $550,000 budget Hazardous Material Consolidation Facility, Building F - 3,500 square feet, $690,000 budget Master Stock Labs and Seismic Upgrade, Building H - 17,000 square feet, $2.1 MM budget Gensler, San Francisco, CA 1989 – 1994

Education:

Bachelor of Architecture, Kansas State University, 1983 Associate Degree in Building Engineering & Technology, Vermont Technical College, 1979 OSHA 30-Hour Construction Safety and Health

Professional Affiliations

Licensed Architect – California, Colorado, Wisconsin & Florida American Institute of Architects – Member

ISPE – Member

National Council of Architectural Registration Boards - Certificate Holder Presentations:

Containment Design Conference, Bridgewater, NJ, December 2005 Case Study: Oral Dosage Pilot Plant – Containment isolators for potent compound handling ISPE, Washington, DC, July 2005

Case Study: Final Isolation Lab – Containment isolator for drying and packing of bulk drug products

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