Mitch Rosner

Mitch Rosner Email and Phone Number

Leader| Quality| Compliance | Analytical Development | QMS | GMP | GLP | GCP | GDP | Risk Management | Validation | Continuous Improvement | Teams @ AnaptysBio
Mitch Rosner's Location
San Diego, California, United States, United States
Mitch Rosner's Contact Details

Mitch Rosner personal email

n/a

Mitch Rosner phone numbers

About Mitch Rosner

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

Mitch Rosner's Current Company Details
AnaptysBio

Anaptysbio

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Leader| Quality| Compliance | Analytical Development | QMS | GMP | GLP | GCP | GDP | Risk Management | Validation | Continuous Improvement | Teams
Mitch Rosner Work Experience Details
  • Anaptysbio
    Vice President Of Quality
    Anaptysbio Sep 2020 - Present
    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 analytical test method validation for drug substance, drug product. GLP oversight of vendors for protocol compliance, test article characterization, stability and chain of custody plus analytical and bioanalytical methods to support nonclinical testing. Proper master schedule maintenance, data and sample archiving plus organization structure oversight of CROs are also a responsibility.GCP oversight of vendors qualification and monitoring and auditing of clinical sites, Principal Investigators, IRB/EC, investigational medicinal products accountability, protocol deviations and bioanalytical methods validations to support clinical testing.AnaptysBio is a clinical-stage biotechnology company developing first-in-class immunology therapeutic product candidates to patients. AnaptysBio is focused on emerging immune control mechanisms applicable to inflammation and immuno-oncology indications. AnaptysBio develops product candidates using our proprietary antibody discovery technology platform, which is based upon a breakthrough understanding of the natural process of antibody generation, known as somatic hypermutation, or SHM, and replicates this natural process of antibody generation in vitro. The strategy is to advance the development of AnaptysBio's proprietary product candidates, and where applicable, establish partnerships with leading biopharmaceutical companies where AnaptysBio retains certain development and commercialization rights.
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  • Lutran
    Consulting Director Of Quality And Regulatory Affairs
    Lutran Jun 2016 - Present
    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 and Alzheimer’s.Role includes advising on compliance strategies to help shape research and development programs for early stage private pharmaceutical company.
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  • University Of California San Diego
    Instructor
    University Of California San Diego Jan 2017 - Present
    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 other regional markets in the rest of the world. Finished human and veterinary drugs and biologics, and dietary or nutritional supplements (alternatively called nutraceuticals), as well as the associated component raw materials (including active pharmaceutical ingredients (APIs) and excipients), and packaging and labeling operations will be covered. The outlined topics are similar to those covered by the Book of Knowledge of ASQ for GMP certification.
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  • Aridis Pharmaceuticals
    Vice President Qc/Qa And Analytical Development (Part Time)
    Aridis Pharmaceuticals Nov 2017 - Sep 2020
    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 analytical test method development and validation for drug substance, drug product, bioanalytical methods to support nonclinical and clinical testing. Aridis Pharmaceuticals, Inc. is focused on the development of novel, differentiated therapies for infectious diseases. Complementing the product pipeline is a disruptive platform technology to discover rare, potent human monoclonal antibodies from patients. The anti-infective product portfolio of Aridis also includes additional preclinical anti-infective drug candidates. This suite of anti-infective monoclonal antibodies is highly differentiated from conventional antibiotics, effective against all antibiotic resistant strains which the mAbs are directed against, and offers opportunities to profoundly impact current approaches to infection control.
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  • Quality Consulting Associates
    Principal Consultant
    Quality Consulting Associates Jan 2016 - Sep 2020
    Quality Consulting Associates offers various services to clients in biotechnology, pharmaceutical, device, nutraceutical and foods from either small very focused to long term multifaceted projects. All work is performed to meet regulations and standards based on phase appropriateness and customer needs. All scope of work is developed with client input and applying standard project management tools. Areas of specialization include:• Analytical test method development and validation• Specification setting based on safety data• Stability study design and evaluation for shelf-life determinations• Packaging and labeling evaluation• Pre-formulation and formulation development• Technology Transfers• Auditing for GMP, GLP, GCLP, GCP both internal and external (Certified Quality Auditor and Certified Biomedical Auditor by ASQ)• Quality System development and improvement• Quality Investigations (CAPA, Deviations, OOS/OOT, etc.)• Documentation Control and Management• Batch Production Record review• HACCP Plan development (NEHA HACCP Manager)• Food Safety (FSPCA Preventative Controls Qualified Individual)• Risk Management• Quality Agreements• Process Metrics (DMAIC and Control Charts)• Training to meet GXP requirements for employee qualificationQC and QA are in our name. The client is the central focus.
  • Synthetic Genomics
    Sr Director Analytical Sciences And Quality
    Synthetic Genomics Jan 2014 - Dec 2015
    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, protein characterization, and specific nutritional supplements analyses are major responsibilities of the team. Utilization of spectrophotometry, HPLC, GC, mass spectrometry (LC/GC-MS and MS-MS), TOC/N, and complex sample preparation are the more routine techniques instituted in Analytical.In role as Quality Manager have been responsible for leading the Quality organization for cGMP approval at SGI's Imperial Valley Facility for phototrophic algae production. Improved the initial quality system for 21 CFR 110 and 111 by authoring overriding Quality Manual and HACCP for the site. Audited third party toll manufacturers and developed Quality Agreements for all contracts to meet GMP's. Hosted successful audits by California Dept. of Public Health Food and Drug Division site for license and GMP third party certification by NSF. Leading continuous improvement plan for ongoing cGMP plan. Oversee both QA and QC for product stability, quality and release.
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  • Algenol Biotechnology
    Senior Director Of Analytical Chemistry
    Algenol Biotechnology Jan 2011 - Jan 2014
    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 intermediates and final product. Team developed targeted metabolomics platforms in phototrophic strains for central metabolites employing isotopomer ratios, relative changes and pool sizes determinations to support molecular engineering. Techniques utilized included FIA with both UV and Fluorescence, High Resolution LC-MS, GC-MS, TOC, PAGE, Western Blot, kinetic enzymatic activity and wet chemistry.
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  • Florida Gulf Coast University
    Courtesy Faculty Appointment, Department Of Chemistry And Mathematics
    Florida Gulf Coast University 2011 - Jan 2014
    Fort Myers, Florida, Us
    Guest lecturing in the Department Chemistry. Member of the University Environmental Health and Safety Committee.
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  • Infrasign, Llc
    Acting Chief Operating Officer
    Infrasign, Llc Jul 2010 - Jan 2011
    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.
  • Novartis Pharmaceutical Corporation
    Head Of Analytical Sciences - San Carlos
    Novartis Pharmaceutical Corporation Jan 2009 - Apr 2010
    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 and microbiological techniques.
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  • Nektar Therapeutics
    Senior Director Pharmaceutical Development
    Nektar Therapeutics Jan 2005 - Dec 2008
    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.
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  • Gilead Sciences (Formerly Cv Therapeutics)
    Director Pharmaceutics (Last Position) And Lead In Quality Control & Analytical Chemistry
    Gilead Sciences (Formerly Cv Therapeutics) Jun 1993 - Jan 2005
    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 Scientist in Analytical & Pharmaceutical Sciences. (1997-2000)Group Leader in Quality Control | Analytical Development. (1995-1997)Scientist in Quality Control. (1993-1995)As lead scientist in Analytical Chemistry and QC, have been responsible, since inception of company, for developing, improving, transferring and validating chemical analyses. Supported all facets of product development for an emerging pharmaceutical company specializing in treatments for cardiovascular diseases. Managed budget, equipment, projects, and staffing.
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  • Biogen Idec
    Analytical Biochemist
    Biogen Idec Jun 1991 - Jun 1993
    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.
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  • California Department Of Health Services
    Research Associate
    California Department Of Health Services Jan 1989 - May 1991
    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.

Mitch Rosner Skills

Biotechnology Gmp Analytical Chemistry Glp Validation Pharmaceutical Industry Drug Development Biopharmaceuticals Life Sciences Fda Hplc Sop Chemistry Technology Transfer Laboratory Good Laboratory Practice U.s. Food And Drug Administration Standard Operating Procedure Research And Development Clinical Development Chromatography High Performance Liquid Chromatography Clinical Trials Laboratory Skills Cro Formulation Medical Devices Lc Ms Regulatory Submissions Quality Control Regulatory Affairs Quality System Pharmaceutics Quality Assurance Drug Discovery R&d Microbiology Bioinformatics Mass Spectrometry Drug Delivery Toxicology Protein Chemistry Cro Management Cmc Lifesciences Gas Chromatography Liquid Chromatography Mass Spectrometry Ind

Mitch Rosner Education Details

  • University Of Arizona
    University Of Arizona
    Pharmacology And Toxicology
  • University Of Arizona
    University Of Arizona
    Toxicology
  • The George Washington University
    The George Washington University
    Chemistry
  • University Of California, Santa Cruz
    University Of California, Santa Cruz
    Project And Program Management

Frequently Asked Questions about Mitch Rosner

What company does Mitch Rosner work for?

Mitch Rosner works for Anaptysbio

What is Mitch Rosner's role at the current company?

Mitch Rosner's current role is Leader| Quality| Compliance | Analytical Development | QMS | GMP | GLP | GCP | GDP | Risk Management | Validation | Continuous Improvement | Teams.

What is Mitch Rosner's email address?

Mitch Rosner's email address is mh****@****gwu.edu

What is Mitch Rosner's direct phone number?

Mitch Rosner's direct phone number is +123949*****

What schools did Mitch Rosner attend?

Mitch Rosner attended University Of Arizona, University Of Arizona, The George Washington University, University Of California, Santa Cruz.

What are some of Mitch Rosner's interests?

Mitch Rosner has interest in Science And Technology, Education, Environment.

What skills is Mitch Rosner known for?

Mitch Rosner has skills like Biotechnology, Gmp, Analytical Chemistry, Glp, Validation, Pharmaceutical Industry, Drug Development, Biopharmaceuticals, Life Sciences, Fda, Hplc, Sop.

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