Brian Miller Email & Phone Number

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.

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.

• 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.

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.

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.

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.

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.

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).

Ph.D., Pharmaceutical Chemistry

B.S., Chemistry