Project Manager On-Site

WILLIAM J. SPENCER

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

Oceanside, CA 92058

Ph: 760-***-****

***************@*****.***

SUMMARY

Productive project manager with more than 25 years of hands-on experience in facility construction and development, multidisciplinary industrial research, production, and management. Equally adept as an individual contributor or in a team environment with senior managerial experience. Project lead that was directly responsible for the design, construction, and commissioning of numerous capital improvement and build-out biotech projects. Extensive hands-on research and production experience in all aspects of biotechnology science, process optimization, and implementation. Extensive background in scheduling, business/facilities management, and operations. Proven effectiveness in working with local jurisdictions for project completions.

PROFESSIONAL EXPERIENCE

Bio-Process Improvement Consulting, Westborough MA / San Diego CA February 2017 –

Proprietor / Lead Project Manager

Set up schedules and provide national consulting services for clients requiring assistance in new construction, renovations, expansions, full buildouts, and process stream improvements of laboratory facilities. Directly worked with clients at their on-site facilities regarding the design and construction of clean rooms and water systems. Services provide audits and recommendations based on Code of Federal Regulations (CFR) mandates.

Liaison between clients and local jurisdictions (Board of Health, Planning Boards, Building Commissioners, Fire Inspectors) to facilitate workflow with an emphasis on limiting change requests during facility builds or renovations and to help ensure compliance with local regulations including but not limited to zoning compliance, building codes, and public health regulations.

Act as owner’s agent in building design recommendations with design professionals.

Review design documents and building plans on behalf of clients.

Recommend and implement long-term needs based on the client’s development activities.

CRB Builders LLC., Medford, MA February 2017 – May 2022

Construction Project Manager

Work with biotech clients to ensure understanding of the project scope and vision. Oversee the beginning of each turn-key project, including details addressing permit submission and design evaluations. Create the schedule for each project and match talent to the job. Processed change-orders and RFIs. Collaborate with the architect and construction crews to ensure the feasibility of each project. Conducted meetings on-site with the architect, client, and construction crew. Negotiate with vendors, suppliers, and subcontractors. Prepare and submit project estimates to clients. Responsible for fiscal reporting and disclosure and monthly report-outs.

Joined the 4LEAF consultant team as a project inspector on the $2.4B construction of a new Casino and Hotel in Everett MA. Responsible for inspections which included rough frame, above ceiling, firestopping, rough mechanical, drywall inspection for fire-rated wall assemblies, and full fire suppression systems. Addressed daily inspection requests and wrote daily inspection reports. Interact and attended meetings regularly with architects, project managers, and contractors.

Collaborated with 4LEAF in all aspects of inspections.

Performed research and interpreted building code for inspection, design and conformance to MSBC 8th Edition.

Maintained and researched relationships with the outside business community to develop potential collaborations in with Bio-Tech and Bio-Pharma companies.

Participate in code review of design drawings and building plan submittals.

Proficient with construction software (Procore, Autodesk BIM)

PALL Life Sciences, Westborough, MA February 2011 – January 2017

Sr. Director /Operations

Project Manager who directly oversaw the construction of a multi-million-dollar facility 4-year renovation build-out. Acted on behalf of the owners as the conduit between owners, general contractor, and building department for conformance to design specifications, approved plans, and MSBC. Provided day-to-day pre-walks of construction during the various phases of the project for code compliance. Interacted daily with project engineers, architects, contractors, and building officials. Responsible for all aspects of operations for the New England Center of Excellence (NECoE) facility including continuous improvement, logistics, compliance, finance approval, continuous site development, health and safety, procurement, planning, and site engineering. Develop and manage departmental capabilities in the NECoE facility. Provide commercial and business leadership and develop revenue-generating activities targeted to recover operational costs.

Vista Biologicals Corporation, Carlsbad, CA February 2007 – January 2011

Site Project Lead

Over three years, was directly responsible for all renovation and expansion construction related to development activities for conformance with Federal, State, and Local laws including but not limited to California State Building Code (CBC) and Public Health regulations. Interacted daily with project engineers, design teams, and contractors for the approval of design drawings and compliance to approved plans, design drawings, and documents.

Bayer HealthCare, Berkeley, CA

Sr. Manager, Technical Operations Process Support

Responsible for all operational and scientific aspects of the department’s activities. Developed strategies to optimize project output with consideration of licensure specifications. Directed efforts for closure of production incident reports and served as purification “subject matter expert” to determine product impact.

•Directly supervised the design, construction, and completion of a Clinical Manufacturing Facility (CMF – 130). Successful participation on the design review board and project management team to bring the project in on time and at budget.

SeraCare Life Sciences, Inc., Oceanside, CA

Director, Manufacturing, Diagnostics Division

Accountable for all aspects of the company’s manufacturing department. Directly responsible for all construction activities – on-site renovation and new construction work. Instrumental in the project planning recommendation and oversight of all expansion projects.

•Directly supervised construction of 1.5M, Class 10,000 clean room and water processing system renovation project.

•Implemented procedures to increase process yields.

•Developed and oversaw the management of manufacturing production schedules, plans, and budgets.

•Collaborate with the validation group to support process and equipment validation activities.

•Implemented and enforced all aspects of cGMP/ISO-13485, and FDA-compliant manufacturing.

INVITROGEN CORP., Carlsbad, CA

Bioprocess Engineer/Fermentation-Purification Group Leader, Department of Custom Services

Supervised and performed microbial fermentation runs scaling from 2L to 150L. Utilized yeast, microbial, and baculovirus expression systems. Responsible for experimental design, scale-up, transfer, and down-stream processes for research and development to manufacturing.

Performed and validated protein purifications by FPLC/HPLC and determined feasibility for large-scale processes.

Made recommendations and designed optimization experiments for custom fermentation/protein purification services.

Generated and purified all commercial enzyme and antibody products for manufacturing, ensuring QA specifications.

PROTEIN POLYMER TECHNOLOGIES, INC., San Diego, CA

Scientist/Fermentation Supervisor, Bioprocessing Division

Supervised and performed fermentation runs scaling from 2L to 1000L reactors. Maintained a strict cGMP/GLP/FDA-compliant environment. Utilized microbial expression systems at a preparative scale. Responsible for technology transfer to contract manufacturing facilities.

Optimized operating procedures to increase specific productivity.

Wrote standard operating procedures, analytical methods, and validation protocols in compliance with cGMP/GLP/FDA specifications.

Characterized proteins by HPLC, PAGE/Western blotting, and other procedures in support of the expression department.

Senior Research Associate, Material Science Division

Developed techniques in multifunctional labs to interface between material science and protein chemistry.

Performed depositions on proprietary substrates.

Executed modifications on coagulation proteins.

Performed protein sponge assembly for tissue augmentation projects.

EDUCATION/ PROFESSIONAL DEVELOPMENT

University of California (UCSD), San Diego CA

B.Sc. Biochemistry, 1988

Massachusetts Institute of Technology (MIT) Professional Sessions: Fermentation, Downstream Processing

U.C. Extension – Industrial Biotechnology, Experimental Design, Project Management, Team Building, and Personal Management courses

Certifications / Licenses

ICC _ Certified Building Official – Cert #8882880

ICC – Commercial Building Inspector – Cert #8882880

ICC – Residential Building Inspector - Cert #8882880

Rhode Island Certified Building Official – Residential Inspector

CA Driver’s License – Active C541871

FAA – Private Pilot License (VFR) – Cert #2386330

OSHA 30 certification

CAREER ACHIEVEMENTS

Site Lead – Full responsibility for all aspects of operations for a Fortune 500 company’s district headquarters.

Elected Official – Served 5 years as the Vice Chairman, Planning Board, Westborough MA

Revenue Enhancement – As a project manager has delivered numerous projects under budget and on time resulting in over $20M in capital savings.

Technical Consultant – Started and maintained sole propriety of a consulting firm advising on facility renovations, buildouts, reconfiguration, and specific process improvements.

President’s Award – Received the PALL LifeScience President’s awards in 2013 and 2015 for dedication and action in achieving the company's long-term goals.

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