“Zinnia worked in my group (CMC Product Development) for 2.5 yrs as lead method development scientist. She was the group expert and starting point for all issues relating to HPLC method development, experiment design, data interpretation, and troubleshoooting. Of equal importance, she assured that all HPLC systems in our laboratory were properly maintained and working at all times. In her tenure, Zinnia reliably and single-handedly developed all drug product HPLC methods during the lead optimization, GLP Tox, and early clinical development phases of multiple ArQule projects. She was capable of independently evaluating and adapting starter (API) methods to virtually any drug product assay and impurities method, with impressive speed. Her solid grasp of fundamental HPLC knowledge and applications was always apparent, and she leveraged these skills daily to add efficiency and multi-tasking capability to a plate full of different projects and molecules. Zinnia was also responsible for USP-compliant dissolution method development for immediate release capsules and tablets, as well as sustained release tablets. Upon completing the development, optimization, and performance assesment stages of clinical drug product methods, Zinnia collaborated closely and effectively with contract lab counterparts to plan and manage the transfer/qualification of methods into cGMP test environments. As needed, Zinnia traveled to contract lab sites to observe or directly participate in method transfer experiments. I appreciated her willingness to do this, as this up-close analytical presence assured both on-time and quality outcomes. Zinnia never failed to deliver on any method development, transfer, or qualification assignment, both in-house and externally, during critical GLP Tox and clinical manufacturing campaigns. Zinnia also developed and transferred UV-Vis methods for in-process cGMP testing of parenteral drug products. In at least a couple of instances, in order to support clinical batch manufacturing, Zinnia traveled to the CMO to perform the in-process testing herself. Zinnia was always a true professional while at ArQule, always demonstrating self-accountability and conscientiousness to detail and quality. We could always count on her seeing any challenging analytical activity or problem all the way through to completion with proper resolution.”
About
Experienced Analytical Development and QC (ADQC) leader with deep expertise in CMC…
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At Revolution Medicines, our remarkable culture is built on a shared commitment to our core values and principles that guide us in our mission to…
At Revolution Medicines, our remarkable culture is built on a shared commitment to our core values and principles that guide us in our mission to…
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Pranathi Perati was running out of time to treat her stage-four pancreatic cancer when she found out she would get another shot: a clinical trial…
Pranathi Perati was running out of time to treat her stage-four pancreatic cancer when she found out she would get another shot: a clinical trial…
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My daughter and I volunteered at #Jacobs& Cushman San Diego Food Bank today. The holiday season is over and the school is about to start. To me, this…
My daughter and I volunteered at #Jacobs& Cushman San Diego Food Bank today. The holiday season is over and the school is about to start. To me, this…
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6 people have recommended Zinnia
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Thanksgiving is a time to reflect on what we’re grateful for. At Revolution Medicines, our team tops the list! This week, we gathered to celebrate…
Thanksgiving is a time to reflect on what we’re grateful for. At Revolution Medicines, our team tops the list! This week, we gathered to celebrate…
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Excited to announce my new role as Principal Business Systems Analyst - QC at Regeneron in Rensselaer, NY since last November. Looking forward to the…
Excited to announce my new role as Principal Business Systems Analyst - QC at Regeneron in Rensselaer, NY since last November. Looking forward to the…
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We’re excited to announce the launch of ExpectRAS.com, to help improve awareness on the prevalence of RAS in patients with pancreatic ductal…
We’re excited to announce the launch of ExpectRAS.com, to help improve awareness on the prevalence of RAS in patients with pancreatic ductal…
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November is #LungCancerAwarenessMonth. Lung cancer is the leading cause of cancer deaths in the U.S. Our research is aimed at developing innovative…
November is #LungCancerAwarenessMonth. Lung cancer is the leading cause of cancer deaths in the U.S. Our research is aimed at developing innovative…
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This Pancreatic Cancer Awareness Month, we’re honored to welcome the Pancreatic Cancer Action Network to our campus to help increase awareness about…
This Pancreatic Cancer Awareness Month, we’re honored to welcome the Pancreatic Cancer Action Network to our campus to help increase awareness about…
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I am delighted to share that Prof. Kevan Shokat and my book has now been published - “RAS Drug Discovery: Past, Present and Future” – a comprehensive…
I am delighted to share that Prof. Kevan Shokat and my book has now been published - “RAS Drug Discovery: Past, Present and Future” – a comprehensive…
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