ISPE San Diego Chapter Gilead Sciences, Inc. - Building 800 Facility Tour Thursday, February 23, :00 pm - 8:00 pm
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1 ISPE San Diego Chapter Gilead Sciences, Inc. - Building 800 Facility Tour 5:00 pm - 8:00 pm Location: Gilead Sciences, Inc., Building Ocean Ranch Blvd, Oceanside, CA Sponsored By: CRB Siemens Water Works Inc Program Manager: Speakers: Schedule: Noel Maestre, Project Manager, CRB Eric Hanson, Director Biologic Support Operations, Gilead Sciences, Inc. Brad Kraus, Project Manager, DPR Construction Jeff Wegner, PE, Mechanical Engineer, CRB Speaker invited from DGA Architects 5:00-6:00 pm Registration and Networking Dinner 6:00-6:45 pm Presentations 6:45-7:50 pm Tour Thank you To Our Annual Sponsors Platinum Gold Silver
2 ISPE San Diego Chapter Gilead Sciences, Inc. - Building 800 Facility Tour 5:00 pm - 8:00 pm Synopsis: This session will discuss the case study of a recent lab/office/cgmp WH project in Oceanside, CA for Gilead Sciences, Inc. It will focus on the first hand experiences of the owner, designer and GC who will discuss the ingredients of the project that enabled success in what seemed to be an unrealistic timeline. The focus of the talk will be on team formation, process and technical execution, decision making and technology utilized to deliver on time and under budget while meeting the owner and ultimate end user expectations. About Gilead Sciences: Gilead Sciences, Inc. is a research-based biopharmaceutical company that discovers, develops and commercializes innovative medicines in areas of unmet medical need. We strive to transform and simplify care for people with lifethreatening illnesses around the world. Gilead's portfolio of products and pipeline of investigational drugs includes treatments for HIV/AIDS, liver diseases, cancer, inflammatory and respiratory diseases, and cardiovascular conditions. Our portfolio of marketed products includes a number of category firsts, including complete treatment regimens for HIV infection available in a once-daily single pill and the first oral antiretroviral pill available to reduce the risk of acquiring HIV infection in certain high-risk adults. About the Facility: Gilead Sciences, Inc. commissioned DGA Architects to design a new development laboratory and cgmp warehouse facility identified as Building 800 on Gilead s Oceanside campus. The B800 project consisted of approximately 263,000 square feet of interior improvements which included the removal of an entire 38,000 square foot second floor structure and replaced it with a new 97,000 square foot structure increasing the overall building area from 203,000 to 263,000 square feet. The interior lab, office and support improvements consisted of approximately 208,000 square feet with the remainder being left as shell space for future expansion. The project also included exterior building modifications, site and infrastructure improvements. Interior Improvements house development laboratories for the Analytical Operations, Cell Lined Development, Drug Product and Device Formulation, Purification Development, and Cell Culture Development. In addition, improvements house facilities for cgmp and general warehousing for the Oceanside campus.
3 Gilead Sciences, Inc. - Building 800 Facility Tour About the Speakers: Eric Hanson is the Director of Biologics Support Operations for Gilead Sciences' Oceanside campus. He has nearly 17 years of experience in regulated plant operations with 12 years in the biotech industry. Prior to joining the biotech industry, Eric served in multiple capacities as a nuclear trained submariner in the U.S. Navy. Since making the transition from military to the civilian sector, Eric has held a number of roles at Genentech and now Gilead. Starting as a Utility Plant Specialist and culminating in his current role to include Engineering, Supply Chain, Maintenance, Site Services and Capital Expansion. He has successfully led multiple plant startups and the expansion of Gilead s campus in Oceanside from 62,000 square feet to over 400,000 square feet over the last five years. Eric studied Nuclear Engineering Technology at Thomas Edison State College and holds an MBA from California State University, San Marcos. Brad Kraus is the lead the on-site construction team for DPR Construction. He worked directly with Gilead and Design team(dga/crb) from the birth of the project to establish major project milestones and goals. Established a streamlined procurement process to maintain the expedited project timeline while also meeting project budgets. Managed and communicated field and design issues in a timely manner to owner/design team to limit major schedule and cost impacts for the project and ensure project milestones were accomplished. Jeff Wegner is the lead Mechanical Engineer for this 220,000 SF facility, which include cgmp Quality Control Laboratories and support spaces. The facility was executed in a design assist approach and was completed from the start of design to owner occupancy in less than 12 months. Project achieved LEED-CI Silver certification. Mechanical systems include; water-cooled chilled water central plant, single pass VAV air handlers and high-plume laboratory exhaust manifold, hydronic boiler heating hot water system, high pressure steam system, high purity water systems (ASTM Type II Lab Water, WFI-equivalent, USP-PW), clean compressed dry air, vacuum, high purity compressed gases (oxygen, dry nitrogen, carbon dioxide), liquid nitrogen cyro fill, ISO-7 and ISO-8 spaces, downflow booth, lab waste ph neutralization, condensate recovery, kitchen grease duct and waste.
4 ISPE SD Chapter Registration Instructions To Register and receive an immediate receipt, use our on-line registration: ISPE California Chapter Members: If you are an ISPE Member in California, please do not set up a new account, as you should already be in our system. If you do not know your username or password, please Rob Fleming (robgene25@gmail.com) for assistance. ISPE Members of Other Chapters: You will not be in our system unless you have previously set up an account. Please follow instructions for Non Members below. To update your account to a Member account, please forward your confirmation from ISPE or ISPE Membership Card to Rob Fleming (robgene25@gmail.com). We need your Chapter name, your ISPE Member number and expiration date. You can get your Membership card once logged onto the ISPE website (see bottom left side of the screen). Non Members: If you do not have an account on our system, you can set one up on the site using letters (not numbers) as your username. If you need help setting up your account or if you are having problems with the site or need a new password, please Rob Fleming (robgene25@gmail.com) for assistance. Registrations can also be faxed. Complete the form and fax to If paying by check, please mail your check made payable to: ISPE SAN DIEGO CHAPTER, 5319 University Dr., Suite 641, Irvine, CA (949) ISPE San Diego Chapter Tax ID# Registration or Online Questions? Contact Rob Fleming: robgene25@gmail.com Any other Questions, Contact Kimberly Syre: ksyre@cox.net Name Badges will be given at the event Registration Fees: Free for Gilead Employees ISPE Members $60 Non Members $90 REDUCED Student Pricing First 5 Students Free then $20 per student Sponsors $500 (includes table and two attendees) Cancellations must be received via to: ksyre@cox.net by February 16, 2017 for refund. After the cancellation date if you have reserved a space but do not attend, your payment MUST be remitted, however, an alternate person may attend in your place. If the alternate is not a member, they will need to pay the additional amount for non-members. Name Badges will be given at the on-site registration desk.
5 Gilead Sciences, Inc. - Building 800 Facility Tour 5:00 pm - 8:00 pm Registration Form REGISTRATION RATES $60 ISPE Members $90 Non-Members First 5 Students Free then $20 per Student $500 Sponsors FREE for Gilead Employees Sponsors: Your fee includes a 6' Table Top Display and Two Attendees to the meeting. Please supply the name and addresses of your attendee: CREDIT CARD PAYMENT - Please Indicate Type of Credit Card VISA MASTERCARD AMERICAN EXPRESS Name on Card Signature: Credit Card #: Exp Date: YOUR CONTACT INFORMATION: First and Last Name: Title: Company: Address: City: State: Zip: Phone: Fax:
6 Driving Directions: Gilead Sciences, Inc. - Building 800 Facility Tour 4010 Ocean Ranch Blvd Oceanside, CA From Los Angeles/Orange County Take 5 Freeway South to Oceanside. Exit at Oceanside Blvd. Turn Left onto Oceanside Blvd. Go 2.3 miles then Turn Left onto Rancho Del Oro Dr. Turn Right onto Ocean Ranch Blvd. Gilead will be on the left hand side. From Downtown San Diego Take 5 Freeway North to Oceanside. Then take 78 Freeway East. Exit at El Camino Real and Turn Left. Turn Right onto Oceanside Blvd. Then turn Left onto Rancho Del Oro Dr. Turn Right onto Ocean Ranch Blvd. Gilead will be on the left hand side. It is recommended that you look up directions from your starting point to make sure you have the best driving directions.
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