About
Quality Assurance professional with extensive experience within the biotechnology and…
Activity
2K followers
-
Julia Hart reposted thisJulia Hart reposted thisWe are excited to share that the FDA recently cleared our Investigational New Drug (IND) application for UB-VV400, a CD22 directed in vivo CAR T cell therapy for relapsed/refractory B cell malignancies. We expect to treat our first patient in Q3 in our Phase 1/2 study, named VIBRANT-1. UB-VV400 is Umoja's second in vivo CAR T cell therapy to be evaluated in the clinic here in the U.S. Learn more in our press release: https://lnkd.in/gZmjiDpEUmoja Biopharma Announces FDA Clearance of IND Application for UB-VV400, the Industry’s First Known CD22-Directed In Vivo CAR T Cell Therapy for Relapsed/Refractory B Cell MalignanciesUmoja Biopharma Announces FDA Clearance of IND Application for UB-VV400, the Industry’s First Known CD22-Directed In Vivo CAR T Cell Therapy for Relapsed/Refractory B Cell Malignancies
-
Julia Hart reposted thisJulia Hart reposted thisMy team is looking for a process engineer with fill-finish tech transfer experience to help us bring our in vivo CAR-T therapy to more patients. https://lnkd.in/gEjBaE3k
-
Julia Hart reposted thisJulia Hart reposted thisAnother amazing opportunity to be a part of the Umoja Quality Assurance team
-
Julia Hart reposted thisJulia Hart reposted this🚨 Now Hiring: Senior Clinical Trial Manager 🚨 At Umoja Biopharma, we’re advancing innovative immunotherapies with the goal of delivering meaningful impact for patients facing cancer. As our clinical programs continue to grow, we’re looking for a Senior Clinical Trial Manager to help drive the operational execution of our studies. This role is ideal for someone who enjoys being hands‑on, highly collaborative, and deeply involved in the day‑to‑day success of clinical trials. 🔬 What we’re looking for -Experience managing clinical trials with strong operational ownership -Comfort reviewing monitoring visit reports, managing study timelines, and tracking deliverables -Lead the development of study materials (e.g., study plans, monitoring guidelines, site initiation visit materials, site tools and worksheets) -A proactive, organized, and solutions‑oriented mindset -Excitement about contributing to a scaling biotech and helping build strong clinical processes -Independently develop study timelines, key deliverables, and risk/mitigation strategies 👉 Apply today: https://lnkd.in/g94fTEQ4 #NowHiring #ClinicalTrialManager #ClinicalResearch #ClinicalOperations #BiotechJobs #UmojaBiopharma #Hiring
-
Julia Hart reposted thisJulia Hart reposted this🔬 Now Hiring: Associate Director, Clinical & Statistical Programming 🔬 At Umoja Biopharma, we’re working to transform how cancer and autoimmune diseases are treated through our innovative in vivo Car T cell therapy platform. We’re looking for an Associate Director, Clinical & Statistical Programming to help lead high‑quality, submission‑ready clinical programming across our growing portfolio. This is a highly visible role partnering closely with Biostatistics, Clinical Ops, Data Management, and Regulatory to ensure data integrity from study start through regulatory submission. 🧠 This role is a great fit if you: -Thrive at the intersection of strategy, hands‑on programming, and quality -Have a solid comprehension of statistical programming principles, advanced SAS programming expertise, extensive experience in the preparation of regulatory submission packages and substantial knowledge of CDISC standards -Enjoy leading projects and managing, mentoring, and developing teams 📍 Location: Seattle, WA (hybrid) | Remote considered within the U.S. 👉 Apply here: https://lnkd.in/gDY-pgVT #StatisticalProgramming #BiotechJobs #CART #UmojaBiopharma #Hiring
-
Julia Hart reposted thisJulia Hart reposted thisUmoja Quality Assurance (QA) is hiring a Senior Manager of GMP QA Operations. Motivated by aspirations of pioneering in vivo CAR T cell therapies to improve the experience of cancer treatments? Looking to make significant and impactful contributions as a senior leader within the QA organization and maturing Umoja's quality culture? If so, this role may be for you. https://lnkd.in/g8fpzFZR
-
Julia Hart reposted thisJulia Hart reposted this🚨 Now Hiring: Senior Clinical Trial Manager 🚨 At Umoja Biopharma, we’re advancing innovative immunotherapies with the goal of delivering meaningful impact for patients facing cancer. As our clinical programs continue to grow, we’re looking for a Senior Clinical Trial Manager to help drive the operational execution of our studies. This role is ideal for someone who enjoys being hands‑on, highly collaborative, and deeply involved in the day‑to‑day success of clinical trials. 🔬 What we’re looking for -Experience managing clinical trials with strong operational ownership -Comfort reviewing monitoring visit reports, managing study timelines, and tracking deliverables -Lead the development of study materials (e.g., study plans, monitoring guidelines, site initiation visit materials, site tools and worksheets) -A proactive, organized, and solutions‑oriented mindset -Excitement about contributing to a scaling biotech and helping build strong clinical processes -Independently develop study timelines, key deliverables, and risk/mitigation strategies 👉 Apply today: https://lnkd.in/g94fTEQ4 #NowHiring #ClinicalTrialManager #ClinicalResearch #ClinicalOperations #BiotechJobs #UmojaBiopharma #Hiring
-
Julia Hart reposted thisJulia Hart reposted thisWe are excited to announce our poster presentation at the upcoming American Society of Gene & Cell Therapy (ASGCT) Annual Meeting for UB‑VV500, the industry’s first BCMA × GPRC5D in vivo CAR T cell program for the treatment of multiple myeloma. Read the full press release for more details below on the poster presentation, and we hope to see you at ASGCT. https://lnkd.in/geHJfnCDUmoja Biopharma Announces Unveiling of UB-VV500 in Upcoming Poster Presentation at the American Society of Gene & Cell Therapy Annual MeetingUmoja Biopharma Announces Unveiling of UB-VV500 in Upcoming Poster Presentation at the American Society of Gene & Cell Therapy Annual Meeting
-
Julia Hart reposted thisJulia Hart reposted thisHi all! I am excited to announce that I am looking for a Head of Drug Product Development to join our Process Sciences team at Umoja to help us reach more patients with our novel in vivo CAR-T therapies. https://lnkd.in/guK89XFT
Julia Hart commented on a post
1mo
As a potential patient to benefit from your therapies … Godspeed!
-
Julia Hart liked thisJulia Hart liked thisMilestone Achieved: We are proud to share that the first patient has been dosed in our Phase 1 clinical trial evaluating IM-3050, a potential best-in-class radioligand therapy for FAP-expressing solid tumors. We extend our deepest gratitude to the patients and their families for their courage and trust. We also thank the investigators and site teams whose commitment, partnership, and expertise make milestones like this possible. This marks another important step in our mission to develop transformative targeted therapies for people living with cancer. We look forward to advancing IM-3050 and continuing our work to bring innovative treatment options to patients. Read more here: https://lnkd.in/gN-XJ_qu *IM-3050 is an investigational product and has not been approved by the U.S. Food and Drug Administration or any other regulatory authority.
-
Julia Hart reacted on thisJulia Hart reacted on thisStop what you're doing and read this paper. Carl June's group just answered one of the biggest questions in CAR-T: "Is this actually a cure?" The Challenge: - Previous types of immunotherapy(mAbs, biologics, etc) have had a distressing problem - long-term datasets have shown late relapses, quashing early optimism. - For CAR-T specifically, data beyond 5 years have been almost entirely absent. - Therefore, clinicians have been uncertain about whether to use the word "cure" with patients. What June's Group Did: - Evaluated 38 patients with relapsed/refractory B-cell NHL (24 with large B-cell lymphoma, 14 with follicular lymphoma) treated with the CAR-T therapy called CTL019 (tisagenlecleucel) - Median follow-up of 10.1 years (range 7.9 to 11.5) - Assessed lymphoma-free survival, progression-free survival, overall survival, non-relapse mortality, and second primary cancers - Analyzed CAR-transgene persistence as a correlate of long-term response Key Results: - No relapses occurred beyond 5.4 years post-infusion (!!) - 10-year lymphoma-free survival was 32% for LBCL and 47% for follicular lymphoma. - 10-year overall survival was 17% for LBCL and 50% for follicular lymphoma (mostly due to the patients being a heavily pretreated cohort, CAR-T therapy is often the last kind of treatment tried). - Notably, second primary cancer developed in 9 patients (21% cumulative incidence at 10 years), so long term monitoring is still needed - A large portion of patients still have ONGOING CAR-T cell activity almost a DECADE after infusion Implications: This is, arguably, the most consequential clinical data readout in CAR-T cell therapy's history. Especially the absence of relapses beyond 5.4 years. And 47% 10-year lymphoma-free survival (in a heavily pretreated population) is, frankly, remarkable. (This particular cancer is well-known for relapse) CAR-T works. One single infusion can produce a functional cure. Kudos to the team at the University of Pennsylvania, and to the patients who contributed data for over a decade. The future is bright. What are your thoughts on this? Drop them in the comments. Full paper link: https://lnkd.in/gPniizFM
-
Julia Hart reacted on thisJulia Hart reacted on thisTo my network, Six months ago, many of you sat with me through a post I wrote less than a day after Kathy and I made the hardest decision of our lives. We had run out of options for Harrison's care, and we let him go. I held his hand and played music for him as he went. Three weeks ago, you sat with me through a hard Father's Day. I'm not writing today to tell you Harrison died — you know that. I'm writing to tell you what I've decided to do about it. Harrison was 30, a rock climber and outdoorsman who loved fishing at Lake Cleburne. He had a gift for making people feel valued, and he never spoke ill of anyone. For over a decade he fought bipolar I disorder. On November 25, during a severe episode, a fire started inside his truck that he couldn't control. He fought for 34 days in the Burn ICU before we said goodbye. Harrison did not die by suicide. He died in the middle of a psychiatric emergency that wasn't caught in time. Psychosis is not a safe state — it raises risk and needs urgent care, not less. What I've learned: families who get trained and stay openly involved in a loved one's care see measurably better outcomes. Silence is what makes severe mental illness fatal — not the illness alone. I've been asked to serve as Chief Financial Officer, and I'm already a donor, at the National Shattering Silence Coalition, which supports both families and patients. I've also joined THE REAL Mental Health Foundation as an Ambassador, in Harrison's name. If you've lived this yourself, as a patient or a caregiver, I'd welcome you at either organization. And if you're quietly living with bipolar disorder, the Bipolar Social Club (bipolarsocialclub.org) is a private peer community built for exactly that. Talk about this openly. Help us shed the stigma. Consider a donation to NSSC or THE REAL, and please repost this — for Harrison, and for the next family. We buried Harrison at Lake Cleburne, on land that's been in our family for five generations. I still go sit with him with his dog — some evenings with a cigar and a drink, the way we used to. In memory of Harrison White, 1995–2025.
-
Julia Hart liked thisExciting opportunity! BARDA is hiring a QA Division Director! Share this job posting with industry partners and colleagues.Supervisory Quality Assurance Specialist (Division Director)Supervisory Quality Assurance Specialist (Division Director)
-
Julia Hart liked thisJulia Hart liked thisGreat conversations have a way of reminding you that our careers are built through people as much as through the work we do. Yesterday I had the chance to attend the PNW Life Science & Tech Consultants & Industry Allies Summit in Seattle. It was wonderful reconnecting with a former colleague and friend, Kristen Karna, while also meeting so many new people who are passionate about advancing our industry. I always leave these events with fresh ideas, new perspectives, and gratitude for the incredible life sciences community we have here in the Pacific Northwest. Looking forward to continuing the conversations! #LifeSciences #Biotech #Networking #Leadership #ContinuousLearning #Seattle
-
Julia Hart liked thisJulia Hart liked thisFrom living on the streets to being a successful scientist and Nobel Prize laureate. “...at age 4½, I set off on my own. I headed south, sometimes living in the streets, sometimes joining gangs of other homeless children, sometimes living in orphanages, and most of the time being hungry. My recollections of those four years are vivid but not continuous, rather like a series of snapshots. Some of them are brutal beyond description, others more palatable.” Mario Capecchi, born in 1937, spent years on the streets in Italy and nearly died of malnutrition in a hospital. In 2007, he was awarded the medicine prize "for their discoveries of principles for introducing specific gene modifications in mice by the use of embryonic stem cells."
-
Julia Hart liked thisJulia Hart liked thisI was honored to join a panel at #BIO2026 this week to discuss accelerating cell and gene therapies for rare diseases. Over the past several years, the field has evolved from scientific promise to a new era of medicine—one defined by advancing clinical outcomes, optimizing manufacturing capabilities, and moving closer to realizing the curative potential of these therapies for patients. That momentum has been fueled by collaboration across the entire ecosystem. I firmly believe CAR T therapy is a team sport—bringing together scientists, clinicians, regulators, advocates, and industry partners working together to translate innovation into meaningful patient impact. At Kyverna, we’re proud to help shape this next chapter as we work to bring the first CAR T-cell therapy for autoimmune disease to the market. We are committed to building a focused neuroimmunology franchise and a long-term leadership position in this space. Thank you Biotechnology Innovation Organization, our moderator Nicholas Richardson, DO, MPH , and my fellow panelists, Tim Hunt and Matthew Hawryluk , for an insightful discussion. The opportunity ahead is significant, and I’m energized by what we can achieve together for patients. #BIO2026 #CARTcellTherapy #SPS #MG #Biotech
-
Julia Hart liked thisJulia Hart liked thisOn Tuesday the FDA approved a new metastatic breast cancer drug based on Fred Hutch led study. It targets a mutation found in 60 to 70 percent of metastatic breast cancer patients. The drug brings ‘big change, big benefit,’ according to Fred Hutch’s Dr. Sara Hurvitz, who led the study. Read more: https://bit.ly/4fozDiU
-
Julia Hart liked thisJulia Hart liked thisIf you're an ex-FDA professional who has transitioned to independent consulting—or you know someone you highly recommend—I’d appreciate the opportunity to connect. I'm looking for individuals who bring not only deep regulatory expertise, but also a collaborative, pragmatic approach that aligns with the way we serve our clients at Pharmatek Solutions Inc. If this sounds like you (or someone in your network), please send me a direct message or feel free to make an introduction. Personal recommendations are especially appreciated.
Experience
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
-
Organizations
-
Research Quality Association (RQA)
-
- Present -
Association of Clinical Research Professionals (ACRP)
Member
- Present -
Society of Clinical Research Associates (SOCRA)
-
- Present -
Ballard NW Senior Center
Volunteer
- Present -
Parenteral Drug Association (PDA)
Pacific Northwest Chapter - Member At Large
Other similar profiles
Explore top content on LinkedIn
Find curated posts and insights for relevant topics all in one place.
View top content