John Stuart Email and Phone Number
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John Stuart personal email
Focused and resourceful quality leader with extensive experience in quality/laboratory management, chemistry, quality systems, project management, release/stability testing, continuous improvement (CIP), Corrective and Preventive Action (CAPA), and statistical analysis. Proven track record of developing/implementing systems, using strong technical writing, investigation, and communications skills. A highly accomplished and driven contributor who positively impacts an organization to reach/exceed short and long-term operational goals.
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Quality Control ManagerAcumen Pharmaceuticals, Inc. Mar 2022 - PresentGreater Boston, Ma, UsProvide Quality Control Oversight for Drug Substance (mAb), Drug Product and specialized reagents for clinical trial supplies for a monoclonal antibody that binds to amyloid beta oligomers which are widely acknowledged to be major mediators of Alzheimer's Disease pathology. Responsible for analytical method transfer and validation and management of stability program.
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Quality Control ManagerZeochem Oct 2018 - Mar 2022Rüti, Ch, ChManaged the Quality Control Laboratory for the analysis of Zeolites. Responsible for 24/7 production support. -
Associate Director / Senior Manager Quality Control, Drug Product And StabilityKremers Urban Pharmaceuticals Inc. (A Lannett Company) 2014 - 2017Supervised quality control release and stability group, including two managers, five supervisors, 50 chemists, and three administrative assistants, in charge of release/stability testing of marketed solid oral dose pharmaceutical products. Oversaw drug product testing for commercial products and led stability program for marketed/development products. Acted as investigation leader for out of specification results. Led capital purchases of analytical instrumentation and reviewed/approved validation protocols and reports. Administered interdepartmental communications of testing schedules and statuses. Chaired departmental safety program and represented quality control during regulatory inspections (FDA, EMA, DEA, and customers). • Maintained $5,000,000 annual budget with >5% in savings. • Implemented predictive statistics to reduce risk. • Completed release/stability testing on time and used KPIs to improve performance.
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Qc Manager, OperationsUcb Pharma 2008 - 2013Brussels, BeOversaw quality control operations group, including three supervisors, 23 chemists, and one administrative support, in charge of release/stability testing of marketed solid oral dose pharmaceutical products. Directed stability program for marketed/developmental products. Prepared eCTD stability sections for ANDA submissions. Conducted internal audits. Supervised capital purchases of analytical instrumentation. Developed KPI reporting from databases. Led departmental continuous improvement program.• Performed statistical analysis (Minitab) of data and prediction of product failures, using historical data.• Served as investigation leader for out of specification results.• Served as site representative for global quality control excellence program.• Represented quality control during regulatory inspections (FDA, EMA, DEA, and South Korea FDA). -
Qc Manager, OperationsSchwarz Pharma 2004 - 2008UsOversaw quality control operations group, including three supervisors, 23 chemists, and one administrative support, in charge of release/stability testing of marketed solid oral dose pharmaceutical products. Directed stability program for marketed/developmental products. Prepared eCTD stability sections for ANDA submissions. Conducted internal audits. Supervised capital purchases of analytical instrumentation. Developed KPI reporting from databases. Led departmental continuous improvement program. -
Stability ManagerSchwarz Pharma 2001 - 2004UsOversaw stability program to support product expiration dating. Prepared annual stability reports and quality reviews. Supported regulatory submissions and purchased stability chambers. Supervised eight chemists conducting stability and release testing. Served as project leader for Part 11 compliance for UV/Vis systems.
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Qc ManagerAdvanced Chemtech, Inc 1997 - 2001Supervised quality control team and oversaw analytical instrumentation for analysis of pharmaceutical peptides, raw materials, amino acid derivatives/resins, and reagents. Wrote qualifications for analytical instrumentation and methods. Reviewed process and equipment validation protocols. Worked closely with FDA during inspections. Implemented specifications for top 800 catalog products and key raw materials. Resolved customer technical complaints. Audited key vendors.
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Qc Manager / Chemist Technical Srvices And Quality AssuranceCambridge Isotope Laboratories, Inc. 1992 - 1997Tewksbury, Ma, UsSpearheaded quality assurance for pharmaceutical products. Wrote SOPs and operating instructions for cGMP processes and procedures. Prepared and reviewed validation protocols (processes, methods, and equipment) as well as reviewed batch production records and internal auditing of records and procedures. Audited contract laboratories. Managed controlled substance inventory. Served as product manager for high-purity carbon monoxide.Supervised three quality control chemists. Operated and maintained analytical instrumentation (NMR, HPLC, GC/MS, GC, and IR). Worked under cGMP/cGLP protocols for raw material and finished product testing. Wrote SOPs for analytical procedures.
John Stuart Skills
John Stuart Education Details
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Lehigh UniversityOrganic Chemistry -
Moravian UniversityChemistry
Frequently Asked Questions about John Stuart
What company does John Stuart work for?
John Stuart works for Acumen Pharmaceuticals, Inc.
What is John Stuart's role at the current company?
John Stuart's current role is Quality Leader | CIP, CAPA, cGMP, ISO9001.
What is John Stuart's email address?
John Stuart's email address is jo****@****hem.com
What schools did John Stuart attend?
John Stuart attended Lehigh University, Moravian University.
What skills is John Stuart known for?
John Stuart has skills like Validation, Gmp, Quality Control, Pharmaceutical Industry, Hplc, Chromatography, Sop, Analytical Chemistry, Lc Ms, Lims, 21 Cfr Part 11, Capa.
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