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@anaptysbio.com
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1 phone found area 239
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Mitch Rosner is listed as Leader| Quality| Compliance | Analytical Development | QMS | GMP | GLP | GCP | GDP | Risk Management | Validation | Continuous Improvement | Teams at AnaptysBio, based in San Diego, California, United States. AeroLeads shows a work email signal at anaptysbio.com, phone signal with area code 239, and a matched LinkedIn profile for Mitch Rosner.
Mitch Rosner previously worked as Vice President Of Quality at Anaptysbio and Consulting Director of Quality and Regulatory Affairs at Lutran. Mitch Rosner holds Doctor Of Philosophy (Phd), Pharmacology And Toxicology from University Of Arizona.
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AeroLeads found 1 current-domain work email signal for Mitch Rosner. Compare company email patterns before reaching out.
My 30+ years of postdoctoral experiences of strong cross-matrix management and budgeting skills plus diverse technical background have been a strong addition to many teams. My start up experiences required virtual business approaches while my larger company experiences stressed building and maintaining infrastructure; these fit a variety of business models. My skills as as project leader and formal training in project and program management have helped enhance efficient cross matrix teams and departments meet specific goals on time and budget.My biologics, small molecule, food, nutritional supplements, drug and device experiences have given me a broad picture of the cGMP and GLP needs to drive product development through the clinic. I have been a contributor on 6 approved products and an inventor on one approved product. My quality and regulatory responsibilities in several companies have been demonstrated by authoring submissions to Health Authorities in multiple countries, building quality systems, and leading the laboratory Pre-Approval Inspections and as a Board Member of IPAC-RS for 2 years. Applying my strong quality, analytical and metabolomic skills to biofuels applications has been integral in solving problems and creating solutions in an evolving cutting edge organization.Specialties: CMC: 1) Analytical Methods Development + Validation2) Quality Control for all phases of development + commercial3) Stability for drug substance and product + devices4) Pre-formulation + formulation5) PAI readinessQuality (21 CFR 11, 110, 111, 210-211 600-680, 820):1) All relevant Documents and SOP's for Quality Systems, Quality Agreements, HACCP2) Analytical/QC Labs GLP and cGMP2) Specification setting and shelf-life3) Investigations of OOS, OOT + OOE4) Audit of cGMP + GLP CRO's5) Hosting GMP audits by Third Party and Regulatory BodiesPreclinical:1) Test article manufacture and characterization + stability2) Toxicology studies + audits3) Metabolomics
Listed skills include Biotechnology, Gmp, Analytical Chemistry, Glp, and 44 others.
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San Diego, California, US
Responsible for Quality Assurance and Quality Control for all of AnaptysBio programs. This includes all GAMP, GCP, GDP, GLP, and GMP compliance with emphasis on the Quality Management System. GMP oversight of product characterization, release, and stability, technology transfer, and vendor and supplier qualification. Also responsible for specifications and.
San Jose, California, US
LuTran Inc. is a dynamic, innovation–driven pharmaceutical research company located in the heart of Silicon Valley, where we push the boundaries of medical science to discover and develop novel medicines for some of the world's most debilitating viral and neurological diseases: from AIDS through biosafety level 4 viruses,including Ebola hemorrhagic fever.
La Jolla, CA, US
Instructor for Good Manufacturing Practices (BIOL 4000) at UCSD Extension. This course is design to provide a background in compliance with current good manufacturing practices (cGMPs), as regulated and guided by national and international agencies for the pharmaceutical and industry. It will emphasize the US FDA cGMPs but mention differences between the.
Los Gatos, California, US
Responsible for Quality Assurance, Quality Control and Analytical Development for all of Aridis Pharmaceuticals programs. This includes all GAMP, GCP, GDP, GLP, and GMP compliance with emphasis on the Quality Management System, product characterization, release, and stability, technology transfer, and vendor and supplier qualification. Also responsible for.
La Jolla, CA, US
Head of the analytical chemistry team that supports a diverse range of synthetic biology technologies with a major focus on chemicals, food and nutritional supplements and biofuels derived from heterotrophic and phototrophic algae hosts. Metabolomic, lipidomic, carbon-flux, fatty acid methylester characterization (FAME), total carbon and nitrogen analyses.
Fort Myers, FL, US
Head of analytical chemistry and bioinformatics for an emerging biofuel company that focuses on carbon capture, water remediation, ethanol and other green chemistry products. Analytics supported cyanobacteria culture optimization and scale up to commercial scale bioreactors by quantification of nutrients, suppressor and inducer levels, and key.
Fort Myers, Florida, US
Guest lecturing in the Department Chemistry. Member of the University Environmental Health and Safety Committee.
Consulted with Infrasign to develop business plans, fund raising, and new applications for the laser -based Mid-IR platform in security, chemical, and biomedical industries. The start-up firm is focusing on recognition technology that enables identification and quantification of trace levels rapidly with low background.
Basel, Baselstadt, CH
Head of analytical and clinical QC group responsible for methods development and validation, GLP test article characterization, clinical trial material release and stability, and specifications for raw materials, intermediates, drug product, device, and packaging materials. This includes chromatographic, spectrometric, thermal, titrimetric, wet chemical.
San Francisco, California, US
Director, Pharmaceutical Development January 2005- February 2008Head of Analytical Sciences and Pharmaceutical Quality at Nektar Therapeutics. Led Commercial QC up to launch for Exubera. Responsible for methods development and validation, GLP test article characterization, clinical trial material release and stability, and specifications.
Foster City, CA, US
As head of Department of Pharmaceutics have been responsible for (pre)formulation development, and support for early research programs, GLP studies, and drug product development throughout clinical trials and to commercial product. Member of Research Management Committee.Associate Director of Analytical Chemistry | Quality Control (2000-2001)Senior.
Cambridge, MA, US
As lead scientist of department, was responsible for developing, improving, transferring, and validating chemical analyses to support all facets of product development for a biopharmaceutical company specializing in antibodies for treating autoimmune diseases, cancers, and infections. Managed budget, equipment, and staffing for multi-departmental projects.
As a laboratory scientist was responsible for the development of immunochemical analyses of human sera for markers of exposure to airborne carcinogens that were suitable to help the state evaluate health risks.
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Mitch Rosner works for AnaptysBio.
Mitch Rosner is listed as Leader| Quality| Compliance | Analytical Development | QMS | GMP | GLP | GCP | GDP | Risk Management | Validation | Continuous Improvement | Teams at AnaptysBio.
AeroLeads has found 1 work email signal at @anaptysbio.com for Mitch Rosner at AnaptysBio.
AeroLeads has found 1 phone signal(s) with area code 239 for Mitch Rosner at AnaptysBio.
Mitch Rosner is based in San Diego, California, United States while working with AnaptysBio.
Mitch Rosner has worked for Anaptysbio, Lutran, University Of California San Diego, Aridis Pharmaceuticals, and Quality Consulting Associates.
You can use AeroLeads to view verified contact signals for Mitch Rosner at AnaptysBio, including work email, phone, and LinkedIn data when available.
Mitch Rosner holds Doctor Of Philosophy (Phd), Pharmacology And Toxicology from University Of Arizona.
Mitch Rosner is listed with skills including Biotechnology, Gmp, Analytical Chemistry, Glp, Validation, Pharmaceutical Industry, Drug Development, and Biopharmaceuticals.
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