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Tim Mitchell is listed as Vice President of Quality Assurance at Aktis Oncology, based in Boston, Massachusetts, United States. AeroLeads shows a work email signal at askbio.com and a matched LinkedIn profile for Tim Mitchell.
Tim Mitchell previously worked as Senior Vice President of Global Quality - Renal Autologous Cell Therapy at Prokidney Corp. and Vice President of Quality - Dermal Fibroblast Gene Therapy at Castle Creek Biosciences, Inc.. Tim Mitchell holds Master Of Science - (M.S.), Genetic Biology from Purdue University.
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Extensive experience within the human gene and cell therapy, human stem cell therapy, and immuno-biologics industries, focusing substantially in the areas of quality assurance and control, global compliance, process development, manufacturing operations, regulatory affairs, validation, aseptic facility engineering, and site management. Most recent experience has been within the Cell Therapy (CAR-T) development space. Majority of career in direct support of new biologic product development and licensing, from IND submission and clinical production (GCP/GLP/GMP), through each phase of clinical study, final product BLA/NDA filing, and operational transition into commercialization. In-depth knowledge of aseptic and sterile product manufacturing operations. Primary career focus has been associated with cell therapy, biological, and drug parenteral products supporting global compliance assessment and management, through facility design and operational GMP control, finished product manufacturing, labeling, and packaging. Balanced career spent within quality, operations, global compliance, and regulatory, with the majority of those years in management roles overseeing both project activities and operational departments in support of CMC development, clinical, and commercial GMP manufacturing operations. Direct oversight and support of ten (10) new GMP manufacturing facilities worth over $9.7 billion in total constructed/installed costs (career total); all of them being sterile/aseptic manufacturing facilities. Thorough knowledge associated with the establishment and management of CMC regulatory documentation and operational and quality/compliance programs and systems in the support of these new manufacturing facilities, built for both large-scale commercial and pilot-scale clinical production of sterile human cells, biologics, and protein-based pharmaceuticals in compliance with global GMP regulations. Direct face-to-face interaction with FDA (CDER, CBER, ORA), European Union (EMEA, MHRA), Japanese (PMDA), Health Canada, Australian (TGA), and Chinese (CFDA) regulatory authorities regarding IND, ANDA, BLA, and NDA submissions, pre-approval inspections (PAI’s), post-approval (commercialization) GMP inspections, follow-up written communications addressing compliance questions to existing operations, along with new facility design and validation presentations to agency representatives prior to construction.
Listed skills include Quality Assurance, Pharmaceutical Industry, Gmp, Validation, and 24 others.
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Aktis Oncology is working at the forefront of a transformation in radiopharmaceutical therapies, developing first-in-class alpha-emitting agents that safely and efficiently target and destroy cancer cells while minimizing harm to healthy cells.In advanced stage solid tumor cancers with distant metastases, Aktis radiopharmaceutical technology will be used.
Winston-Salem, North Carolina, US
ProKidney, LLC is a late stage clinical cellular therapy company. Our technology has demonstrated effective restoration of kidney function by using the patient’s own (autologous) kidney cells. By contrast, organ transplantation from other donors (allogenic transplants) can be associated with organ rejection and failure. Further, the patient lives with the.
Exton, Pennsylvania, US
Castle Creek Biosciences, Inc., a privately-held, clinical-stage cell and gene therapy company, is focused on developing and commercializing innovative personalized therapies for patients living with underserved disorders with high unmet medical needs. Our approach to personalized biologics is distinctive based on our proprietary, autologous fibroblast.
Rockville, Maryland, US
ICT is building a comprehensive platform of CAR-T products for blood cancers and solid tumors, including an allogeneic CAR-T development program. CAR-T therapies of the future will combine stem cells, gene editing and gene therapy, and ICT is making breakthroughs to combine these technologies, including advances in leveraging hematopoietic stem cells..
At Endocyte, I worked in support of the company's objective to deliver potent therapy to diseased cells, while minimizing the impact on healthy cells. Their proprietary approach is the first to combine small molecule drug conjugate (SMDC) technology with companion imaging agents to assist in therapy selection. More recently, Endocyte has expanded its.
Memphis, TN, US
I served as Cognate's Vice President of Quality and Regulatory in support of the company's new commercial scale cGMP development and manufacturing of genetically altered Cytotoxic T Lymphocytes (CTL's) for cellular therapeutic treatment of various forms of human cancer. Included within my functional areas of responsibility were Quality Assurance, Quality.
From the time I joined Celgene, my priorities were to work with the Phoenix site to lead the preparation for multiple major site pre-approval inspections for 2015 and 2016, and oversee operational commercial start-up of regular manufacturing at full site capacity. The first for 2015 being the European EMEA/MHRA, then the US FDA, finally the Japanese PMDA.
Lexington, KY, US
I worked in support of strategically transitioning the organization away from the University of Kentucky’s operational control into an independently run company. As a member of the Executive Management Team, a good portion of my time and efforts was involved with marketing and financial structuring and monitoring of the company. In order to fully capture.
US
Responsible for final facility design, validation, and operational start-up aspects of the overall new commercial Alpha1 Protease Inhibitor (API) product launch, as well as being responsible for the regulatory compliance posture associated with the new $85 million API manufacturing facility (112,000 sq. ft.). This included the development and maintenance.
I managed the quality, validation, regulatory, and technical departments responsible for supporting licensed human antibody manufacturing operations for NABI at both the new Boca Raton manufacturing complex and various contract manufacturing organizations utilized by NABI. Included within these departments of responsibility were the following functions.
SyStemix, Inc. was engaged in the development of cellular and cell-based gene therapies for cancer, AIDS, and genetic diseases based on the use of isolated, expanded, and gene-modified hematopoietic stem cells.I managed all areas of domestic and European quality assurance and validation for the three SyStemix biological aseptic manufacturing facilities.
Indianapolis, Indiana, US
Responsible for representing Biosynthetic Technical Services and Quality Assurance on the corporate steering committee associated with the validation planning and design of the new Research and Development Manufacturing Facility being constructed in Indianapolis, intended for the manufacture of recombinant derived protein pharmaceutical late-phase clinical.
Indianapolis, Indiana, US
Provided validation and process technical support to the Biosynthetic Manufacturing Division’s commercial manufacture of biosynthetic human insulin (Humulin). I oversaw and responded to the daily technical and quality issues associated with various operational steps of the Humulin process.
Indianapolis, Indiana, US
Supported process development and scale-up of clinical manufacturing for the three (3) Biochemical Purification pilot plants within the Research and Development Division of Lilly Research Laboratories in Indianapolis.
Indianapolis, Indiana, US
Carried out manufacturing activities associated with the commercial fermentation and purification production of Cephalosporins, Tylosin, and Penicillin. Prepared and screened inoculation cultures and performed in-process testing between operational steps of the manufacturing processes.
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Tim Mitchell works for Aktis Oncology.
Tim Mitchell is listed as Vice President of Quality Assurance at Aktis Oncology.
AeroLeads has found 2 work email signals at @askbio.com for Tim Mitchell at Aktis Oncology.
Tim Mitchell is based in Boston, Massachusetts, United States while working with Aktis Oncology.
Tim Mitchell has worked for Aktis Oncology, Prokidney Corp., Castle Creek Biosciences, Inc., Innovative Cellular Therapeutics (Ict), and Endocyte (Novartis).
You can use AeroLeads to view verified contact signals for Tim Mitchell at Aktis Oncology, including work email, phone, and LinkedIn data when available.
Tim Mitchell holds Master Of Science - (M.S.), Genetic Biology from Purdue University.
Tim Mitchell is listed with skills including Quality Assurance, Pharmaceutical Industry, Gmp, Validation, Fda, Quality Control, Biopharmaceuticals, and Medical Devices.
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