Brian Miller

Brian Miller Email and Phone Number

Quality Professional, Experience Supervising Professionals, Chemistry @ Esperion
Brian Miller's Location
United States, United States
Brian Miller's Contact Details
About Brian Miller

Ph.D. degree in pharmaceutical chemistry. Advise and collaborate on cGMP and CMC processes. Direct, build and manage quality systems and laboratory operations. Extensive data quality, process improvement, and auditing experience in both FDA and ISO 17025 arenas.

Brian Miller's Current Company Details
Esperion

Esperion

View
Quality Professional, Experience Supervising Professionals, Chemistry
Brian Miller Work Experience Details
  • Esperion
    Senior Manager Quality Control
    Esperion Aug 2022 - Present
    Ann Arbor, Michigan, Us
    • Provide in depth technical and scientific advice and guidance to contract service providers and analysts related to Quality Control chemistry and operations. This advice includes external laboratory guidance on investigations and deviations.• Review development, release and stability data for routine manufacturing and investigations on DS and DP using various analytical techniques, both remotely and in plant.• Design and implement quality control processes for specifications, methods, reports, etc. both internally and externally to support Esperion’s commercial programs.• Recommend product specifications and test methods commensurate with phased product development.• Ensure testing and release services are provided in support of established schedules by being the primary technical and project management liaison with counterparts at the CMOs and contract laboratories.• Work directly with and provide technical support to operating entities (internal and CMOs) to ensure implementation of testing procedures meet timelines, specifications and remain within budget plans.• Review regulatory submission and supports internal, external audits, and regulatory inspections.• Support the Quality Management group’s efforts of compliance with the quality systems such as change control, quality investigations, CAPA resolutions in corrective action, audits, and any other recommendations to compliance issues and/or observations as they arise.• Support analytical qualification of alternate manufacturing sites, laboratories and service suppliers.• Review and approve stability protocols and reports prepared by CMOs. Assure compliance with ICH guidelines on stability of pharmaceutical products.• Review and trend DS and DP data and prepare documentation for annual product reviews.• Review and approve analytical methods and method validation protocols and reports.• Lead or co-lead cross-functional activities for Technical Operations projects or CMO management.
    View
  • Miller Cgmp Llc
    President
    Miller Cgmp Llc Nov 2016 - Present
    Pharmaceutical current good manufacturing practices (cGMP) consultant specializing in• Quality management (QM) and quality management systems (QMS)• Chemistry, manufacturing, and controls (CMC) development• Equipment qualification and process, computer and method validation support• Process and analytical technology transfer• Auditing of systems, products, and methods.
  • Minnesota Department Of Agriculture
    Quality Assurance Officer
    Minnesota Department Of Agriculture May 2017 - Aug 2022
    • Laboratory Services Division• ISO 17025 accredited quality management system (QMS)• ASQ certifications: CMQ, CQE, CQA• Conduct internal audits• Advise internal customers• Host external accreditation audits • Advise laboratory on best practices and good laboratory practices (GLP)• DEA policy lead• Incident management team / Federal Emergency Management Administration (FEMA) trained volunteer.Strengths include quality systems, method validation, and chemistry.
  • Qol Medical Llc
    Director Qa
    Qol Medical Llc Jan 2013 - Nov 2016
    Vero Beach, Fl, Us
    Maintained change control system.Reviewed and approved MBRs, sampling plans, and test methods.Oversaw process and analytical validation activities in support of master records and test methods.Wrote protocols, coordinated execution, and developed reports.Investigated and managed deviations and out of specification occurrences, and implemented CAPAs both internally and with contract vendors.Issued POs, authorized manufacturing and testing, approved labeling and packaging, and developed and dispositioned quality issues.Developed and maintained stability and retain program, and supported statistics based shelf life expiry determinations.Wrote, reviewed, and approved COAs and stability protocols and summaries.Trended manufacturing and analytical data by tracking and summarizing key performance indicators.Tracked and trended adverse drug experiences and complaints, and performed complaint investigations.Audited contract manufacturers, contract laboratories, and distributors.Developed and reviewed CMC sections for INDs and NDAs.Prepared and supported vendors during regulatory inspections.Maintained training documentation internally and audited vendor training.Reviewed and approved clinical protocols, and assured randomized packaging.Reviewed and approved clinical SOPs.Maintained internal and external audit schedules.Developed and maintained PV agreements and quality agreements with vendors.Wrote, reviewed, and approved SOPs, specifications, protocols, and reports as required.Supported process and analytical development and validation.Characterized sacrosidase using SDS-PAGE, native-PAGE, EndoH and PNGase mediated deglycosylation, peptide mapping, N-terminal and C-terminal sequencing, differential scanning calorimetry, and polarimetry. Characterized sacrosidase process using ELISA, SDS-PAGE, freezing point depression, specific gravity, polarimetry, USP, and BAM chapters.
    View
  • Teva Pharmaceuticals
    Qc Manager / Senior Qc Manager
    Teva Pharmaceuticals 2003 - 2012
    Tel-Aviv, Il
    • Built 24/5 QC operation into fully functional shifts capable of analyzing all products using all instrumentation, and working with CDS, QMS, and SAP systems.• Solved critical analytical problems to support testing in HPLC, GC, Dissolution, and Disintegration, including compendia interpretations and method improvements.• Worked with R&D and regulatory affairs at specification setting.• Developed strong interactions with R&D, QA, logistics, production, HR, and customers by developing communication spreadsheets, participation in internal and external audits, and representing QC in recurring meetings.• Grew department by 50% while maintaining 6 day turn time and ensuring compliance.• Chartered Empower CDS paperless team to streamline analysis and review processes.• Business lead for global Cephalon LIMS system.• Established analytical technology transfer system.• Lead successful transfer of dozens of methods and specifications for several product lines to sister plant.
    View
  • Pfizer
    Qa Manager
    Pfizer 2001 - 2003
    New York, New York, Us
    • Built system for identifying and reducing process impurities in low-dose compounds using HPLC, photodiode array detection (PAD), BOMS, and UV Spectral Libraries, and spiking studies.• Developed extractable / leachable tools and policy in support of corporate team.• Assisted sister plant in solving process contamination of API during manufacture.
    View
  • Orphan Medical
    Quality Assurance Analyst
    Orphan Medical 1998 - 2001
    Us
    • Characterized impurity pathway, including impurity identification, in Xyrem (sodium oxybate) using Mass Spectrometry, pH profiling, and HPLC.• Qualified Reference Standards• Determined critical impurity in Busulfex (busulfan) using ELS, HPLC, derivatization, NMR, and Mass Spectrometry.• Improved formulation robustness of drug substance.
    View
  • United States Department Of Ene
    Student Inter
    United States Department Of Ene Jan 1992 - May 1992
    Developed procedure for quickly extracting and quantifying alpha emitters using crown ether chelation. Learned practical radiation safety principle of as low as reasonably achievable (ALARA).

Brian Miller Skills

Analytical Method Validation Process Validation Quality Management Quality Assurance Quality Control

Brian Miller Education Details

  • The University Of Kansas
    The University Of Kansas
    Pharmaceutical Chemistry
  • St. Cloud State University
    St. Cloud State University
    Chemistry

Frequently Asked Questions about Brian Miller

What company does Brian Miller work for?

Brian Miller works for Esperion

What is Brian Miller's role at the current company?

Brian Miller's current role is Quality Professional, Experience Supervising Professionals, Chemistry.

What is Brian Miller's email address?

Brian Miller's email address is brianmiller@mn.gov

What is Brian Miller's direct phone number?

Brian Miller's direct phone number is +195294*****

What schools did Brian Miller attend?

Brian Miller attended The University Of Kansas, St. Cloud State University.

What are some of Brian Miller's interests?

Brian Miller has interest in Running, Home Improvement Projects, Home Brewing.

What skills is Brian Miller known for?

Brian Miller has skills like Analytical Method Validation, Process Validation, Quality Management, Quality Assurance, Quality Control.

Free Chrome Extension

Find emails, phones & company data instantly

Find verified emails from LinkedIn profiles
Get direct phone numbers & mobile contacts
Access company data & employee information
Works directly on LinkedIn - no copy/paste needed
Get Chrome Extension - Free

Aero Online

Your AI prospecting assistant

Download 750 million emails and 100 million phone numbers

Access emails and phone numbers of over 750 million business users. Instantly download verified profiles using 20+ filters, including location, job title, company, function, and industry.