Manufacturing Specialist, GMP

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 GMP Manufacturing Specialist will collaborate with the R&D and Process Development groups to develop manufacturing processes to support production of cell therapeutics for pre-clinical studies and human clinical trials. The Manufacturing Specialist will be responsible for cGMP production activities and executing cGMP process qualification and validation studies. Duties will include writing new Manufacturing Process documents and manufacturing-related SOPs, validation protocols/reports and other GMP documents that are necessary for ensuring compliance with applicable U.S., Canadian and global standards.

If interested and qualified, please include Requisition # 2023-02 in the subject line when emailing resume to: careers@cladetx.com

Responsibilities

  • Work with the Process Development group to develop manufacturing processes for expansion and differentiation of PSCs.  Perform technology transfer of manufacturing processes to internal and external cGMP manufacturing teams as needed.
  • Prepare specifications for equipment to support cGMP manufacturing.  Procure equipment and support validation of equipment including writing IQ/OQ/PQ protocols and working with the team to execute validation studies and write validation reports.   Prepare SOPs for equipment operation, maintenance and calibration.
  • Work with Quality Assurance to prepare documentation to support cGMP manufacturing including raw material specification (RM), manufacturing procedures (MP) and related Standard Operating Procedures (SOPs).
  • Participate in required cGMP training activities including training on required SOPs and manufacturing procedures.
  • Prepare protocols for aseptic process qualification studies and process engineering runs.  Work with the manufacturing team to execute qualification/validation studies and prepare documentation and reports for review by Quality Assurance and manufacturing staff.
  • Work with the manufacturing team to produce Cell Drug Substance and Product for non-clinical studies and human clinical trials by procuring raw materials, preparing manufacturing facility/equipment, and executing the approved MP.  Work with Quality Assurance to ensure completion of all associated documentation to support cGMP compliance.
  • Work with Analytical Development and Quality Control to develop in-process testing plans.  Assist in the development of appropriate analytical methods as needed.
  • Support Quality Assurance documentation functions for cGMP production, in-process testing, and release testing of cell therapies.   Work with QA to address quality events including deviations, CAPAs, OOS and other failure investigations as needed.
  • Support cleanroom operations including review and tracking of equipment records for PM/calibration and cleanroom maintenance and cleaning.

Qualifications

  • BS in Biology, Biochemistry, Bioengineering, or related field
  • 5+ years of experience in mammalian cell culture required.  Experience in PSC culture and differentiation techniques is highly desirable
  • Experience in cGMP manufacturing with hands-on experience in cell therapy production and aseptic manufacturing techniques is required.
  • Experience in writing SOPs and validation protocols for equipment and manufacturing processes is highly desirable
  • Experience with Good Documentation Practices is required.  Experience reviewing cGMP documentation is highly desirable
  • Excellent written and oral communication skills and the ability to work in a fast paced, dynamic team environment is required
  • Expertise using MS WORD, Excel, and database programs.  Experience in working with an eQMS and/or LIMS is also desirable.

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 # 2023-02 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.