Process Development Specialist

About Clade Therapeutics

Clade Therapeutics is a well-funded, early-stage cell therapy company developing novel cell-based medicines for the treatment of cancer and other devastating diseases. The company was recently founded by an exceptional group of academic leaders and successful bioentrepreneurs. The Company works at the convergence of stem cell biology, immunology, regenerative medicine, and gene editing to create the next-generation of stem cell-derived medicines.

We are passionate about delivering on the promise of cellular therapy, shaping the future of cellular medicine, and delivering new therapies to millions of patients.

Position Summary

The Process Development Specialist will interface with members of the R&D team to develop processes for producing iPSCs and differentiating iPSCs into cell therapies including T-cells, B cells and other immune cells.  This position requires experience in developing processes for production of cell therapies in bioreactors, cell harvest and cryopreservation, and implementation of those processes in a cGMP environment.  The Process Development Specialist will establish scale-down bioreactor models and analytics to support high-throughput media and bioreactor optimization studies.  The Process Development Specialist will also interface with internal and external GMP manufacturing teams to support tech transfer and provide technical support for process changes and investigations.

If interested and qualified, please include Requisition # 2022-62 in the subject line when emailing resume to: careers@cladetx.com

Responsibilities

  • Interface with the R&D teams to provide input on selection of media, reagents and culture methods for early-stage evaluation of differentiation methods and cell line candidates.
  • Create process development plan to support manufacturing for IND-enabling studies, human clinical trials, and process scale-up for late-stage clinical trials and commercial manufacturing. Identify and evaluate technologies, methodologies, and equipment applicable to PSC production, differentiation, harvest and cryopreservation.
  • Establish scale-down bioreactor models and analytics to support media optimization and bioreactor optimization studies. Utilize DOE and other statistical methods to evaluate design space of manufacturing operations, identify Key Process Parameters, and optimize manufacturing processes.
  • Interface with Analytical Development to identify key assays required to support early-stage PD activities. Provide material to AD and Quality Control to support assay development and qualification activities.
  • Interface with internal and external GMP manufacturing teams to support tech transfer and cell therapy manufacturing activities including support for process changes, troubleshooting and investigations.
  • Interface with the Nonclinical Studies team to provide materials for in vivo studies to demonstrate POC and evaluate key process decisions, selection of Drug Product formulation, and evaluation of cell therapy delivery methods.

Qualifications

  • BS in engineering, biological sciences or other relevant discipline with 5+ years of relevant industry experience required or MS/PhD with equivalent experience
  • Experience in upstream process development and GMP manufacturing of biologics is required, experience in cell therapy manufacturing is a plus
  • Experience in optimization of bioreactors and cell culture media with experience in Design of Experiment (DoE) is highly desirable
  • Experience in analysis of cells/media including cell counting, media analysis and flow cytometry is also desirable
  • Knowledge of Current Good Manufacturing Practices (cGMP) and the impact of process design and raw material selection on GMP compliance and regulatory risks

Corporate Values

  • Patients First – Proactively and constructively engage to deliver results for those in need. “Begin with patient’s success in mind”
  • Communication and Respect – Foster open exchange with colleagues and collaborators. Seek to understand and treat people with courtesy. “Better together”
  • Integrity & Excellence – Act honestly and ethically to seek the truth. Courageously doing the right thing – take smart risks and make tough decisions in pursuit of exceptional outcomes. “Get it done right”
If interested and qualified, please include Requisition # 2022-62 in the subject line when emailing resume to: careers@cladetx.com

Clade Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, gender, age, religion, national origin, disability, veteran status, sexual orientation or any characteristic protected under applicable law.

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Jonathan M. Gerber, MD

Jonathan M. Gerber, MD received his undergraduate degree in Biology from Johns Hopkins University in Baltimore, Maryland, where he was inducted into Phi Beta Kappa.  He received his MD from the Johns Hopkins School of Medicine, where he was inducted into Alpha Omega Alpha. He then completed residency in Internal Medicine and fellowship in Hematology, both also at Johns Hopkins. Upon completion of his training, he served on the faculty of the Johns Hopkins School of Medicine for 5 years, in the Division of Hematology. 

Dr. Gerber left Johns Hopkins to found and lead the Leukemia Program at the newly created Levine Cancer Institute (LCI) of the Carolinas HealthCare System in Charlotte, North Carolina. He also helped start the Blood and Marrow Transplantation (BMT) Program at LCI, performing the first allogeneic BMT in an adult in the city of Charlotte in March of 2014.  Additionally, he oversaw the creation of a new inpatient service line and served as the Medical Director of the Department of Hematology and a clinical faculty member at the University of North Carolina School of Medicine at Chapel Hill during his time in Charlotte. 

Dr. Gerber then joined the University of Massachusetts Medical School and UMass Memorial Health Care in 2018 , where he serves as the Chief of Hematology & Oncology and the Medical Director of the Cancer Center.  He holds the Eleanor Eustis Farrington Chair in Cancer Research.

Dr. Gerber’s clinical interests include leukemia and related hematologic conditions, as well as BMT.  He is a translational laboratory researcher and an early phase clinical trial investigator.  His research focuses on improving the identification and targeting of the stem cells at the root of leukemia and other clonal hematologic diseases, with the goal of personalizing therapy and developing better treatments that are more effective and less toxic.  He has published numerous articles in his field, presented his research findings at national & international meetings, and served as a reviewer for the National Institutes of Health and prominent journals.  Dr. Gerber has also received many grants and awards for his research, including funding from the Leukemia & Lymphoma Society and Swim Across America Foundation, as well as the Johns Hopkins University School of Medicine Clinician Scientist and the Passano Foundation Physician Scientist awards.  His work has resulted in several U.S. patents and has been translated into clinical trials.   

Dr. Gerber is a member of the American Society of Hematology (ASH) and the American Society of Clinical Oncology (ASCO). He currently is a member of the ASH Committee on Practice and the Subcommittee on Precision Medicine; and he previously served on the ASCO Cancer Research and Education committees.  Dr. Gerber has served as a member of the board of the Charlotte, NC chapter of the Leukemia & Lymphoma Society and has been an active fundraiser with the Swim Across America Foundation.

Jerome Ritz, MD

Dr. Ritz is currently Professor of Medicine in the Department of Medical Oncology at the Dana-Farber Cancer Institute, Brigham and Woman’s Hospital and Harvard Medical School.

His research laboratory focuses on the assessment of donor immune function after allogeneic hematopoietic stem cell transplantation (HSCT) and characterization of immune mechanisms responsible for graft versus leukemia (GVL) and graft versus host disease (GVHD). These laboratory studies have led to new clinical approaches to enhance GVL and prevent or treat GVHD. His lab also studies other cellular therapies for hematologic malignancies including CAR-T cells and activated NK cells. Working closely with clinical collaborators he has developed approaches to precisely characterize the effects of these treatments on immune function in vivo. These results are correlated with clinical outcomes such as response and toxicity to develop a better understanding of the immunologic mechanisms that contribute to these outcomes.

Dr. Ritz is also the Executive Director of the Connell and O’Reilly Families Cell Manipulation Core Facility at DFCI. This GMP cell manufacturing facility supports both adult and pediatric hematopoietic stem cell transplant programs at DFCI, Brigham and Women’s Hospital and Boston Children’s Hospital and also provides a variety of novel cellular products for patients enrolled on clinical trials at DFCI and affiliated hospitals. This facility recently expanded to include 15 cleanrooms available to manufacture a variety of cellular products including genetically modified stem cells, genetically modified immune cells, regulatory T cells, natural killer cells and other complex cellular products. This facility is a critical resource for both academic investigators and industry sponsors interested in developing innovative cellular therapies.

Derrick Rossi, Ph.D.

Derrick Rossi received his B.Sc. and M.Sc. degrees from the University of Toronto, Canada in the 1990s, and his Ph.D. from the University of Helsinki, Finland, followed by post-doctoral training at Stanford University. Dr. Rossi is an Associate Professor in the Department of Pediatrics at Harvard Medical School. He is also an investigator in the Program in Cellular and Molecular Medicine at Boston Children’s Hospital, where he holds a Boston Children’s Hospital Pediatrics Chair. Dr. Rossi has been a principal faculty member of the Harvard Stem Cell Institute since 2008.

Dr. Rossi’s lab at Harvard Medical School focuses on diverse aspects of hematopoietic stem cell biology, including how aging of the stem cell compartment contributes to disease pathogenesis and aging-associated hematopoietic decline. His efforts in the development of cutting edge technologies and new therapeutic strategies are at the forefront of regenerative medicine and biotechnology. Discoveries made in Dr. Rossi’s lab have led to the formation of several leading biotechnology companies. In 2010, Derrick Rossi founded Moderna Therapeutics, a clinical-stage company focused on developing modified-mRNA therapeutics. In 2015, Dr. Rossi co-founded Intellia Therapeutics, a Cambridge-based company focused on developing CRISPR/Cas9 based therapeutics. In 2016, he co-founded Magenta Therapeutics, which is focused on transforming transplantation medicine. Dr. Rossi is currently serving as the founding CEO of Convelo Therapeutics where he leads a team that is developing regenerative therapies for demyelination diseases of the central nervous system.

Time magazine cited Dr. Rossi’s discovery of modified-mRNA reprogramming as one of the top ten medical breakthroughs of 2010. Time magazine also named Dr. Rossi as one of the “People Who Mattered” in 2010, and as one of the 100 Most Influential People in the world (Time 100) in 2011.

Chris Sturgeon, PhD

Scientific Co-founder

Dr. Sturgeon is an Associate Professor at the Icahn School of Medicine at Mount Sinai. He earned a Ph.D. in Biochemistry on cell cycle regulation at the University of British Columbia. Dr. Sturgeon completed postdoctoral studies at the McEwen Centre for Regenerative Medicine at the University of Toronto, studying pluripotent stem cell-derived hematopoiesis. Prior to joining Mount Sinai, Dr. Sturgeon was a member of the Washington University School of Medicine Hematology Division. His studies focus on characterizing the signal pathways that control human pluripotent stem cell differentiation towards hematopoietic stem/progenitors, and how this impacts the development and function of immune cells.

Gustavo Mostoslavsky, MD PhD

Scientific Co-founder

Dr. Mostoslavsky received his MD from the University of Tucuman in Argentina and his Ph.D. from the Hebrew University in Jerusalem, Israel. His longstanding interest in basic science and regenerative medicine brought him to Harvard Medical School to pursue postdoctoral studies with stem cells and gene therapy. In 2008 Dr. Mostoslavsky opened his lab at Boston University. He is currently an Associate Professor of Medicine in the Section of Gastroenterology in the Department of Medicine at Boston University School of Medicine. His main research interests are stem cells, disease modeling, regenerative medicine, gene correction, and lentiviral vectors as gene transfer tools. Dr. Mostoslavsky is a founder and Co-Director of the BU Center for Regenerative Medicine (CReM).

Deepta Bhattacharya, PhD

Scientific Co-founder

Deepta Bhattacharya received his Ph.D. from the University of California, Berkeley, where he studied the NF-kB transcription factor’s role in survival and B cell class switching. For his postdoctoral fellowship, he trained at Stanford University, studying the cell biology of hematopoietic stem cells and their differentiated progeny. In 2008, he launched his lab at Washington University in St. Louis, first as an Assistant Professor and then as a tenured Associate Professor. Dr. Bhattacharya returned in 2017 to his birthplace of Tucson to join the Department of Immunobiology, where his lab continues to study both stem cells and antibody responses to infections and vaccines.

Neil White

Board Director

Neil has over 10 years of experience in the life sciences sector, spanning investment banking and leadership roles. Previously he worked in Capital Markets at Bank of America Merrill Lynch, and in Healthcare Mergers & Acquisitions advisory at Torreya Partners and Perella Weinberg Partners. He is now an investment manager in the Health Team of Emerson Collective, focused on investing in and supporting the clinical translation of novel treatments in oncology and improving the lives of cancer patients. Neil received his MSc (Res) from the University of Oxford and BSc (Hons) from the University of Toronto. 

Martin Murphy, PhD

Board Director

Martin is Chief Executive Officer of Syncona Investment Management Ltd. He co-founded Syncona in 2012 alongside The Wellcome Trust. Since then, Martin has been closely involved in the foundation and development of seven Syncona companies, including: Achilles Therapeutics, Autolus, OMass Therapeutics, Quell Therapeutics, Anaveon and Resolution Therapeutics. He is Chairman of Quell and Anaveon and is a Director of Autolus, Resolution, Neogene Therapeutics and Clade Therapeutics. He was previously Chairman of Blue Earth Diagnostics, which Syncona sold to Bracco Imaging for $476 million in 2019.

Previously, he was a partner at MVM Life Science Partners LLP, a venture capital company focused on life science and healthcare, where he led their European operations. Martin has also held roles with 3i Group plc and McKinsey & Company. He has a PhD in Biochemistry from the University of Cambridge.

Daniel Vasella, MD

Chairman of the Board

After the foundation of Novartis in 1996 he led the company for 17 years as CEO (1996-2010) and Chairman of the Board of Directors (1999-2013). Since 2013 Dr. Vasella is Honorary Chairman of the Board of Directors for Novartis AG.

Before the Novartis merger, Dr. Vasella was CEO of Sandoz Pharma Ltd. and a member of the Sandoz Group Executive Committee. From 1988 to 1992, he worked for Sandoz Pharmaceuticals Corporation in the United States, prior to which he held a number of medical positions in Switzerland. He graduated with an M.D. from the University of Bern and completed executive training at Harvard Business School.  Dr. Vasella also trained as psychoanalyst and executive coach.  He was awarded an honorary doctorate from the Faculty of Medicine at the University of Basel and the Harvard Business School Alumnus Award and many other distinctions.

Dr. Vasella is a member of the board of directors of PepsiCo, Inc., the American Express Company and biotech companies. He is also a foreign honorary member of the American Academy of Arts and Sciences, as well as of various cultural establishments.

Daniel Vasella is married and father of three children.

Jim Glasheen, PhD

President / Chief Business Officer, Co-Founder

Over the past 25 years, Jim led efforts to translate biomedical innovations into broader societal impact as an academic, a strategic consultant, a venture investor, and an executive. Previously, he was co-founder and founding President and CEO of Atalanta Therapeutics, Executive Vice Chancellor at UMASS Medical School, co-lead of Life Science Practice at Technology Partners Venture Capital, and a leader within the Pharmaceutical and Medical Products practice at McKinsey & Company. His training includes a post-doctoral fellowship at University of California, Berkeley, a PhD from Harvard University, a Deutscher Akademischer Austauschdienst Fellowship at Universität des Saarlandes and a BS from Duke University.

Chad Cowan, PhD

Chief Executive Officer, Co-Founder

Chad has over 20 years of experience leading cutting-edge research groups and translating early discoveries into therapies. His prior roles include co-founder and Chief Scientific Officer at Sana Biotechnology and co-founder and Head of Research at CRISPR Therapeutics. Chad has also played an early role in the launch of several gene and cell therapy companies including, BlueRock Therapeutics, Vesigen Therapeutics, Metagenomi, and Vita Therapeutics.

Chad received his BA and BS from the University of Kansas. He received his Ph.D. from the University of Texas Southwestern. In 2006 he was named a Stowers Medical Investigator. In 2008, he became a Professor at Harvard University, Harvard Medical School, and the Harvard Stem Cell Institute, where he led academic research groups and taught.