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I have 4 years of experience as a part-time math instructor & manager of supplemental math learning center for K - 12th grade students. I am also a retired pharmaceutical stability chemist with over 30 years of experience as a stability coordinator SME (subject matter expert) & Research Scientist for R&D registration stability study programs and for annual ongoing commercial market batch stability study programs (over 20 innovator NDAs & generic ANDAs for over 50 product codes) for parenteral I.V. premixed drug solution injection products in flexible plastic containers and/or glass vials. I am a detailed, team-oriented, and flexible stability professional with excellent problem-solving & communication skills. KEY WORDS:TUTOR | INSTRUCTOR | MATH | K-12 MATH| ALGEBRA | GEOMETRY | TRIGONOMETRY | CALCULUS | STATISTICSPHARMACEUTICAL | STABILITY | R&D | SCIENTIST | COORDINATOR | CHEMIST | ENGINEER | PLANNER | QUALITY | REGULATORY | DEVELOPMENT | SHELF LIFE | EXPIRY | FORMULATION | INTRAVENOUS | PREMIXED | COMPOUNDED |
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Math InstructorMathnasium - The Math Learning Center Mar 2023 - Jun 2023South Barrington, Illinois, United StatesFranchisee is Schoolhouse 4 Math -
Math InstructorMathnasium - The Math Learning Center Sep 2021 - Mar 2023Barrington, Illinois, United StatesFranchisee is Schoolhouse 4 Math.
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Lead InstructorMathnasium - The Math Learning Center Sep 2020 - Aug 2021Lake Forest, Illinois, United StatesFranchisee is Schoolhouse 4 Math.
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R&D Project ManagerPharmedium Services - Part Of Amerisource Bergen Company Mar 2019 - Apr 2020Lake Forest, IlRoom Temperature & Refrigerated Compounded Sterile Preparations of Drug Solution Injection Products in Flexible Plastic Containers and/or Plastic Syringes● Design & assessment of stability test method validation protocols. ● Preparation, review, & execution of stability testing protocols. ● Design & review of statistical evaluations of stability data for shelf-life proposals. Interact effectively with statisticians via oral & written communications. ● Manage new product evaluations based upon current stability data. ● Manage the development of new compounded products & processes. ● Develop & review SOPs in support of new & current products. ● Perform project tracking in order to create new services to current offerings. ● Manage container-closure & sterility testing of new products, as applicable. ● Support on-going stability studies related to sterility & chemical testing of current products. ● Interact with management personnel at headquarters, outsource compounding centers (in NJ,TN, & TX), including Sales, Marketing, Legal, Quality Management, Quality Assurance, Operations, etc. ● Travel as needed to compounding centers & contract laboratories in support of stability batch products & stability study testing. ● Interact with outside suppliers & customers.● Manage stability study activities with contract laboratories. Review all data & reports for acceptance. Evaluate alternate contract laboratories for utilization with comparison to current contract laboratories. ● Manage R&D activities related to complaint sample investigations.
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Center DirectorMathnasium - The Math Learning Center Sep 2018 - Mar 2019Grayslake & Gurnee, IlFranchisee was Keep On Learning Corporation.
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Assistant Center DirectorMathnasium - The Math Learning Center May 2018 - Aug 2018Grayslake & Gurnee, IlFranchisee was Keep On Learning Corporation.
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Math InstructorMathnasium - The Math Learning Center Jan 2018 - Apr 2018Grayslake & Gurnee, IlFranchisee was Keep On Learning Corporation.
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Pharmaceutical Stability Chemistry ConsultantPharmaceutical Stability Chemistry Consultant Jul 2015 - Mar 2019Greater Chicago AreaPHARMACEUTICAL STABILITY SPECIALTIES:● Formulation Design of Intravenous (I.V.) Premixed Drug Products in Flexible Plastic Containers● Frozen (-20℃) Drug Products with Thawed (5℃ or 25℃) Label Storage Periods● Room Temperature (25℃) Drug Products with Intermediate (30℃) & Accelerated (40℃) Storage● Stability Study Design, Protocols, & Reports:○ New Drug Product Registration○ Generic Drug Product Registration○ Changes to Existing Drug Products (e.g., API, formulation, processing, container)○ Ongoing Annual Commercial Market Batch Stability Program● Trend Evaluation & Stability Data Reviews:○ Result Approval on Stability LIMS○ Laboratory Investigation Support for Suspect OOS & OOT Results○ Plant Investigation Support of Manufacturing Exceptions & Suspect OOL Release Results○ Plant Annual Product Reviews○ Customer Inquiries● Verification & Approval of Stability Data Update for Annual Reports to NDA & ANDAs● Evaluation of Stability Data for:○ Long-Term Shelf-Life (Expiration Dating Period)○ Short-Term Label Periods (e.g., Thawed, Reconstituted, Out-of-Pouch, Out-of-Carton, etc.)○ Acceptability of Release & Product Specifications○ Collaboration with Statisticians on Evaluation of 95% Confidence Bounds● Technical Justification & Stability Reports for Expiry Recommendations:○ Long-Term Shelf-Life (Expiration Dating Period)○ Short-Term Label Periods (e.g., Thawed, Out-of-Pouch, Out-of-Carton, etc.)● CMC ICH 3.2.P.8 Stability Section for NDA, ANDA, & PAS● SME for Stability Impact Assessments for Drug Product & Container Changes ● Support PAI (Pre Approval Inspections) & GMP Inspections of Plant● Support Customer RequestsICH, FDA, & WHO GUIDANCES:Q1A, Q1B, Q1C, Q1D, Q1E, Q1F (WHO), Q3A, Q3B, Q6A, OOS, etc
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Board Of Directors, Chicago SectionAmerican Chemical Society Jan 2017 - Dec 2018Greater Chicago AreaBoard of Directors: Elected Term 2017 - 2018. -
Public Relations Committee, Chicago SectionAmerican Chemical Society May 2016 - Dec 2018Greater Chicago AreaPublic Relations Committee: Member 2016 - 2018.
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Research Scientist I (Stability Planner)Baxter Healthcare May 2002 - Jun 2015Round Lake IlStability Studies of Frozen & Room Temperature Premixed Intravenous (I.V.) Drug Products in Flexible Plastic Containers & Premixed I.V. Drug Products in Glass Vials:● Designed & study directed GMP stability study protocols: ○ New and/or Generic Drug Product Development Registration Stability Studies. ○ Changes to Existing Drug Products (e.g., API, formulation, processing, container). ○ Ongoing Annual Commercial Batch Stability Program & SOP. ● Trend Reviews & Stability Data Reviews to support: ○ Approval of results on Stability LIMS. ○ Laboratory Investigations for Suspect OOS / OOT stability results. ○ Plant's Annual Product Reviews. ○ Plant Investigations for manufacturing exceptions & suspect release OOL results. ● Evaluated Stability Data for: ○ Long Term Storage Shelf Life Recommendations (Expiration Dating Period). ○ Short Term Thawed Label Period Recommendations. ○ Acceptability of Release & Product Specifications. ○ Collaborated with Statistician on Evaluation of 95% Confidence Bounds. ● Developed & defended Technical Justification & Stability Reports for long term shelf life & short term label periods.● Authored CMC ICH 3.2.P.8 Stability Sections of regulatory submissions (e.g., NDA, ANDA).● Served as SME & Technical Consultant for drug product stability to both R&D personnel & manufacturing quality personnel. ● Stability Operations Representative in cross-functional project teams for both new product development & changes to existing products. ● Identified & implemented process improvements, as needed. ● Informally mentored: ○ Research Associates via verification & approval of their stability updates to Annual Reports, etc. ○ R&D, Regulatory, & Quality personnel on drug product stability & formulation matters. ● Concurred on protocols & reports from cross-functional teams for stability batch productions, process validations, regulatory plans, design review documents. -
Research Associate Iii (Stability Planner)Baxter Healthcare Jun 1991 - May 2002Round Lake IlStability Studies of Frozen & Room Temperature Premixed Intravenous (I.V.) Drug Products in Flexible Plastic Containers and Premixed I.V. Drug Products in Glass Ampoules in Anesthesia Tray Kits:● Designed & study directed GMP stability study protocols: ○ New Drug Product Development Registration Stability Studies. ○ Changes to Existing Drug Products (e.g., API, formulation, processing, container). ○ Ongoing Annual Commercial Batch Stability Program. ● Trend Reviews & Stability Data Reviews to support: ○ Plant's Annual Product Reviews. ○ Plant Investigations for manufacturing exceptions & suspect release OOL results. ● Evaluated Stability Data for: ○ Long Term Storage Shelf Life Recommendations (Expiration Dating Period). ○ Short Term Thawed label Period Recommendations. ○ Acceptability of Release & Product Specifications. ○ Collaborated with statistician on Evaluation of 95% Confidence Bounds. ● Developed & defended Technical Justification & Stability Reports for long term shelf life & short term label periods.● Authored CMC ICH 3.2.P.8 Stability Sections of regulatory submissions (e.g., NDA, ANDA).● Authored Stability Updates to Annual Reports for NDA & ANDA submissions. ● Served as SME & Technical Consultant for drug product stability to both R&D personnel & manufacturing quality personnel. ● Stability Operations Representative in cross-functional project teams for both new product development & changes to existing products. ● Identified & implemented process improvements, as needed. ● Informally mentored: ○ Research Associates via verification & approval of their stability updates to Annual Reports, etc. ○ R&D, Regulatory, & Quality personnel on drug product stability & formulation matters. ● Provided input on protocols & reports from cross-functional teams for stability batch productions, process validations, regulatory plans, design review documents, etc.
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Research Associate I & Ii (Formulator & Supervisor)Baxter Healthcare Apr 1988 - Jun 1991Round Lake IlFormulation Development of Frozen Premixed Drug Products in GALAXY® Plastic Containers and Room Temperature Premixed Drug Products in VIAFLEX® Plastic Containers.● Study directed laboratory protocols for formulation stability, lab batch manufacturing, target buffer, target tonicity adjustor, & pH titration studies for cephalosporin & beta-lactam antibiotic premixed drug products.● Supervised and/or mentored Research Assistants in execution of above studies. ● Represented Formulation group on cross-functional project teams for deliverables & technical issues. ● Verified & reviewed original data & lab reports from Research Assistants. ● Wrote formulation study reports.● Wrote manufacturing solution mixing procedures with proposed release & product limits for scale-up & registration batch production. ● Presented formulation stability results & mixing procedures at cross-functional technical review meetings. ● Observed registration batch productions in manufacturing plant & advised plant (when requested). ● Drafted formulation stability section of NDA & ANDA submissions. ● Acted as technical consultant on formulation matters to cross-functional project team. ● Helped the Research Assistants with testing, sample transfer storage, & batch sample preparation as needed.
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Research Assistant I & Ii (Lab Assistant)Baxter International Inc. Apr 1984 - Apr 1988Morton Grove IlFormulation Development of Frozen Premixed Drug Products in VIAFLEX® & GALAXY® Plastic Containers:● Prepared laboratory batches & filled test samples for premixed cephalosporin & beta-lactam antibiotic product formulations for frozen (-20℃) long-term storage.● Tested formulation samples for protocol formulation stability studies:○ Drug & Impurities via HPLC○ Drug via UV spectroscopy during batch preparation○ Osmolality via freezing point osmometer○ pH via pH meter○ Dextrose via HPLC or Optical Rotation (batch preparation only)○ Visual Inspection ○ Solution Color via Klett-Summerson colorimeter● Transferred samples from frozen storage to short term thawed (5℃ or 25℃) storage with appropriate storage periods for formulation study test intervals.● Delivered formulation study samples to other laboratories as needed (e.g., particulate matter).● Titrated formulation batches to develop database for manufacturing procedure pH adjustment steps.● Prepared test samples with varying amounts of tonicity agent to determine "iso-osmotic" target amount. ● Documented original data in notebooks and/or worksheets.● Reviewed colleague's' original data.● Study directed testing protocols for titration, target buffer, & target tonicity agent studies.● Wrote reports for testing protocol studies.
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Co-Operative Education StudentThe Dow Chemical Company Aug 1981 - Dec 1983Midland Mi & Granville OhA total of 12 months of work experience as a co-op student with Dow for 4 separate projects alternating with academic semesters at Illinois State University. For each industrial project, interacted with multi-disciplinary teams, performed experiments, documented original data, wrote reports, and presented results to management & team. Midland, MI● 1981 Fall: DOWEX® anion exchange resins. ● 1982 Summer: Polymeric complexes with various industrial compounds. ● 1983 Summer: DOWCO® herbicides. Granville, OH● 1983 Fall: ETHAFOAM® packaging products. -
Undergraduate Teaching Assistant (Uta)Illinois State University Jan 1983 - May 1983Normal IlUTA for General Chemistry Laboratory Class at ISU's Department of Chemistry. Assisted the professor with instruction of students during laboratory sessions and graded both quizzes & lab reports.
Bill Hayward Skills
Bill Hayward Education Details
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Gpa = 3.57/4.00
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Grade = B -
"Statistics & Pharmaceutical Stability Prediction" -
"Pharmaceutical Stability Testing To Support Global Markets", Aaps Press, 2010Independent Study -
"Handbook Of Stability Testing In Pharmaceutical Development", Springer Media, 2009Independent Study
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"Statistical Design & Analysis Of Stabilitystudies", Chapman & Hall / Crc, 2007Independent Study
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"Drug Stability For Pharmaceutical Scientists", Elsevier - Academic Press, 2014Independent Study
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Parenteral Drug Association - Midwest Chapter, Northbrook Il"Microbiology / Microbial Contamination & Control"
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Pittsburg Conference On Analytical Chemistry And Spectroscopy, Chicago Il"Basic Statistics" And "Statistical Tests Applied To Analytical Chemistry"
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Barnett International, Media Pa"Stability Testing : Compliant Study Design, Bracketing, Matrixing, & Out-Of-Spec Test Data"
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Aai International, Wilmington Nc"Pharmaceutical Stability: Current Regulations & The Analytical Search For Degradants"
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Barnett International, Media Pa"Stability Testing: Latest Study Designs & Regulatory Updates To Achieve Harmonization"
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The Center For Business Intelligence, Woburn Ma"Stability Data Management"
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Aai International, Wilmington Nc"Pharmaceutical Stability: Statistical Applications, Regulatory Updates, & Industry Practices"
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Chicagoland Pharmaceutical Discussion Group (Cpdg), Downers Grove Il"Formulation Of Parenteral Drug Products: How Hard Can It Be ?"
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The Center For Professional Advancement, East Brunswick Nj"Stability Of Liquid Pharmaceuticals"
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The Center For Professional Advancement, East Brunswick Nj"Drug Product Stability And Shelf-Life"
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American Chemical Society Short Course, Mundelein Il"Protein Chemistry For Pharmaceutical Products"
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Brown County High School (Bchs), Mount Sterling IlFirst Honor Student
Frequently Asked Questions about Bill Hayward
What is Bill Hayward's role at the current company?
Bill Hayward's current role is Part-Time Math Instructor - Retired Pharmaceutical Stability Chemist.
What is Bill Hayward's email address?
Bill Hayward's email address is bi****@****ter.com
What is Bill Hayward's direct phone number?
Bill Hayward's direct phone number is +184794*****
What schools did Bill Hayward attend?
Bill Hayward attended Illinois State University, The Ohio State University, University Of Wisconsin-Madison, "pharmaceutical Stability Testing To Support Global Markets", Aaps Press, 2010, "handbook Of Stability Testing In Pharmaceutical Development", Springer Media, 2009, "statistical Design & Analysis Of Stabilitystudies", Chapman & Hall / Crc, 2007, "drug Stability For Pharmaceutical Scientists", Elsevier - Academic Press, 2014, Parenteral Drug Association - Midwest Chapter, Northbrook Il, Pittsburg Conference On Analytical Chemistry And Spectroscopy, Chicago Il, Barnett International, Media Pa, Aai International, Wilmington Nc, Barnett International, Media Pa, The Center For Business Intelligence, Woburn Ma, Aai International, Wilmington Nc, Chicagoland Pharmaceutical Discussion Group (Cpdg), Downers Grove Il, The Center For Professional Advancement, East Brunswick Nj, The Center For Professional Advancement, East Brunswick Nj, American Chemical Society Short Course, Mundelein Il, Brown County High School (Bchs), Mount Sterling Il.
What are some of Bill Hayward's interests?
Bill Hayward has interest in Social Services, Children, Environment, Education, Poverty Alleviation, Science And Technology, Disaster And Humanitarian Relief, Animal Welfare, Arts And Culture, Health.
What skills is Bill Hayward known for?
Bill Hayward has skills like Gmp, Regulatory Submissions, Pharmaceutical Industry, Sop, Chemistry, Stability, Fda, Pharmaceutics, Formulation, Shelf Life, Expiration Dating, Hplc.
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