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A new product launch, a clinical study, or regulatory submission are all examples of projects in life sciences.

In performing their jobs, PMs in the life sciences are taking on more cross-functional responsibilities. And while asked to wear many hats, they must still ensure the final product or program is delivered on time, within budget, and in compliance.

Our experienced panelists will share their knowledge and tips on how to drive and successful complete projects in all phases of the life sciences industry.      

PDU's:

Early Bird Premium (Recordings + Coupons)

as of 

 $15.00 (Members & Non-members)

$35.00 + $3.77 Fee (Members & Non-members)

Register

Carl Albertson 

He has over 30 years of diversified experience in engineering and project management in the biotech, aseptic and pharmaceutical processing industry. His experience ranges through all phases of project design including design, construction, commissioning and qualification. He is currently the Director of the capital projects department at BioMarin in Novato, CA.

BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions with focus on rare (orphan) genetic diseases.

Carl was the overall project manager responsible for all facets of the newly and state of the art gene-therapy manufacturing plant project of BioMarin.

Lori Chelemedos

Lori Chelemedos (Panel Moderator) is the CEO and principal consultant at Pac-Side LLC, a management consulting firm specializing in regulatory compliance, quality systems and business process improvement projects in the pharmaceutical industry.

Previously, she was the Associate Director of GxP Inspection Management at BioMarin partnering with senior leadership, middle management, and subject matter experts (SMEs) to prepare for and support Health Authority inspections. She also worked as a Technical Senior Manager in the Global Quality Inspection Management department at Roche/Genentech supporting the Americas, APAC, and Europe with Health Authority inspection readiness/execution including various process improvement projects. She also held roles at Roche/Genentech in IT, Production, and Quality either leading or participating in the improvement of business processes and technology.

Previous to entering the biotechnology field, she performed business process and technology work in the semi-conductor, telecommunications, energy, shipping, and apparel industries with a focus on Manufacturing, Supply Chain, and Quality operations. Lori holds Master of Business Administration from Golden Gate University, a Certificate in Quality and Compliance from UC Berkeley, is trained in APICS, Lean, and Six Sigma, and is currently pursuing a Doctor of Business Administration at Golden Gate University.

Heike Abeck

Heike Abeck (PE, PMP) is currently Senior Director of MSAT, Analytical Methods at Bayer in Berkeley, CA. She has over 20 years experience in the biotech industry, starting as a process engineer with Bechtel and then moved into manufacturing as a specialist with Chiron.

She held positions of increasing responsibility at Chiron in Engineering, Capital Projects, and Chemistry Manufacturing & Controls (CMC) Project Management, ultimately responsible for managing cross-functional process development teams through the clinical product development lifecycle.

After Novartis acquired Chiron, she spent two and a half years on a global assignment with the Sandoz division of Novartis in Austria on several BioSimilars. Upon return from Austria, she worked as Associate Director of Project and Portfolio Management at Novartis Diagnostics and then as Director of Manufacturing Sciences and Technology. After Grifols acquired Novartis Diagnostics, Heike moved to Bayer in Berkeley leading the validation and submission of the next generation Factor VIII product Jivi.

Heike then moved to Germany to support the transfer of Factor VIII production to Bayer, Wuppertal. Unfortunately, this project was discontinued and Heike is back in Berkeley heading up the MSAT Analytical Methods team focusing on optimizing, transferring and troubleshooting QC release testing methods.

Heike received a BS in Chemical Engineering from UC Berkeley and a combined MS in Engineering Project Management and Technology Management from Berkeley Engineering and Haas School of Business. She is a member of PMI, InternationalSociety of Pharmaceutical Engineers (ISPE), co-led the German American BusinessAssociation (GABA), and was on the board of the Bay Area Kinderstube, BAKS+.

Heike is an avid cyclist, surfer, and ultimate frisbee player and enjoys spending time with her husband, 13 and 7 year old sons.

Stephen Smith

Stephen Smith is currently Senior Director of Program Management at Encoded Therapeutics Inc. Prior to joining Encoded, Stephen has led drug development and life cycle teams for Clovis Oncology, Audentes Therapeutics, Medivation, Genentech, Gilead Sciences, and Elan Pharmaceuticals, working in oncology, gene therapy, virology, and neurology.

Stephen earned a Master’s of Science in Project Management with high honors and a Master’s in Business Administration with highest honors from Golden Gate University and a Master’s of Art in East Asian Art with distinction from the Sotheby’s Institute of Art London.

To maintain his passion for art and lifelong learning, he currently serves on the Golden Gate University Alumni Board of Directors and is a Schools Programs Docent at the Asian Art Museum of San Francisco.

Joe Yee

Joe Yee is the currently the Senior Director of CMC Project Management at Sangamo Therapeutics, where he and his team are responsible for the development and delivery of products in support of early and late phase clinical programs in the area of Cell and Gene Therapy.

He has over 20 years of industry experience, starting his career at Chiron Corporation as a Manufacturing Associate, eventually working his way through positions in Manufacturing, Engineering and Validation before dedicating the last ten years of his career on Project Management.

Joe received a BS in Biochemistry from UC Davis and holds Project Management Certifications from UC Berkeley Extension and the Project Management Institute.

Cancellation and No-Show Policy:

If you have made a reservation and find that you will be unable to attend, please send an email to rsvp@wccpda.com and cancel your ticket as early as possible.  Paid registration cancellation are subject to a $5 fee if done during the early bird period. Cancellations after the early bird or event starts are subject to full charge to ensure the Chapter does not incur excessive expenses. All refunds will be issued after two credit card-billing cycles.