PDA Pacific Northwest: Early Career Professional Panel

Irina Abrahamson has a degree in Molecular, Cellular, and Developmental Biology from the University of Washington. She has been working in the pharmaceutical industry for 8 years within Quality Control (QC) and Quality Assurance (QA). She has experience with conducting and managing investigations, root cause analysis, supplier quality, auditing, and continuous improvement. She is currently the Manager of the QA Operations Team at Partner Therapeutics.

I am, Adam Bebee, the Manufacturing Manager at the Therapeutic Cell Production Core with Seattle Children’s Therapeutics (SCTx). I have been with Children’s for a little over 10 years and been part of the immunotherapy program for clinical trials since we kicked off the first (of now 14, 16 by years end) clinical trials supported by Seattle Children’s. I’ve learned pretty much everything I know about GMP manufacturing in that time working through process and protocol development and scaling R&D to GMP. I went to school at Willamette University and studying biology and chemistry and worked in biotech prior to my current role, working on natural product drug discovery and structural analysis. I have had the privilege of learning and working alongside very experienced GMP minds and of course amazing research led my Dr. Mike Jensen.

Christine attended Seattle University and has almost 20 years of clinical trial experience, she worked as a Clinical Research Coordinator on clinical trials at the Benaroya Research Institute at Virginia Mason for 15 years, working on studies focused on autoimmunity, anesthesia, surgery, cardiology, medical devices, and oncology. Her career in the biopharmaceutical industry started as a Clinical Research Associate at Stryker Emergency Care (Redmond) working on projects for the EU Medical Device Regulations. Her most recent roles have been at Zymeworks Inc. and currently at Alpine Immune Sciences in Clinical Supply Chain. Areas of expertise are clinical supplies management, packaging/labeling, logistics, import/export, and clinical operations.

Michelle Gross has a degree in Chemistry from University of Washington.  She has been working in the pharmaceutical industry for 15 years within Quality Control (QC).  She has experience with method validation, transfers, and qualifications from various companies through her career with a primary focus on analytical methods such as HPLC, UPLC, and CE for clinical and commercial biological products.  She has been growing her career from analyst to supervisor.  She is currently supervisor for the QC tech transfer group at Seagen, Inc.

Tamara is a Manufacturing Sciences and Technology (MSAT) Sr. Manager with Bristol Myers Squibb at the Bothell, WA Cell Therapy Manufacturing facility. In this role, she oversees a team of process engineers supporting the manufacture of clinical and commercial cell therapy products for US and global markets. Previously, she has held individual contributor and leadership roles in Quality Assurance Deviation and CAPA Management, Quality Systems Compliance, and Quality Control. Tamara is an avid learner, is passionate about developing high performing teams and strives to continuously improve to develop agile and efficient production systems.

Laura Maloy started working at a local laboratory bench in 1991 running HPLC. She subsequently served Seattle-area life science companies in a variety of QC, QA, consulting, and management positions. A “second-career” attorney, Laura earned a law degree from Seattle University in 2009 while working full-time. She now provides counsel regarding laws, rules, and regulations related to clinical development and commercial manufacturing of drugs and devices.