John Trimble Email and Phone Number
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210-388-1920 Proven experience in pharmaceutical/biopharmaceutical manufacturing, and traditional (503A)/outsourcing (503B) pharmacies. Project Management expertise in end-to-end solutions for manufacturing and project-oriented research, operational performance initiatives, and technical projects. Quality Control/Quality Assurance/Regulatory Affairs roles in compounded preparations, innovative new chemical entities, vehicles, formulations, drug substance candidates, equipment, and supplies. Product Development/Process Validation of generic/branded manufactured drugs, and sterile/non-sterile compounded preparations. Currently a Senior Manufacturing Consultant to sterile biopharmaceutical manufacturing and pharmaceutical outsourcing clients. Excellent communication, strategic, problem solving and analytical skills including the following core competencies:* Skills: USP, cGMP, ICH, and FDA Guidelines; Innovative Pharmaceutical Compounded Product Formulations; New Product Management; Lean Six Sigma Manufacturing* Software: Excel, PowerPoint, Project, and Word; Blue Mountain Asset Management; Master Control Information Management; PK Compounding Management; Qualityze Quality Management; SAP Resource Management* Systems: Cleanroom Analytical Balances, Laminar Airflow Workstations, and Repeater Pumps; Environmental Monitoring; Non-Sterile Liquid, Powder, and Semisolid Fillers and Mixers; QC Chromatography; R&D Instruments
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Senior Manufacturing ConsultantWells PharmaSan Antonio, Tx, Us
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Senior Manufacturing ConsultantWells Pharma Apr 2023 - PresentHouston, Tx, Us* Built relationships with key stakeholders and leadership to influence innovative culture and objectives.* Developed strategies to address issues and find solutions that move projects forward.* Improved R&D function’s operational performance, to meet the requirements of regulatory authorities, company standards, SOPs, and external and internal customers. -
Senior Manufacturing ConsultantScorpius Biomanufacturing, Inc. Feb 2023 - PresentSan Antonio, Texas, Us* Supported deviation and CAPA resolution with SME and quality teams.* Provided input and support to MSAT/PD during development and scale up activities as necessary.* Supported facilities in ensuring proper functionality of the equipment calibration and preventative maintenance as part of the equipment control program. -
Senior Manufacturing ConsultantAzzur Group Jun 2022 - PresentHatboro, Pennsylvania, Us -
Senior Manufacturing ConsultantFujifilm Diosynth Biotechnologies Jun 2022 - Feb 2023Billingham, Gb* Coordinated with QA team to conduct OOS investigations of Upstream and Downstream Biopharmaceutical Manufacturing.* Achieved with Compliance team to establish metrics criteria for Batch Documentation Review and Project Deviation Closure.* Produced with Manufacturing team to develop Cell Culture Safety Levels, Basic Equipment, Laboratory Layout, Aseptic Technique, and Biological Contamination. -
Director Of Research And DevelopmentCarie Boyd Pharmaceuticals Apr 2021 - Mar 2022Irving, Texas, UsProduct Development (R&D)* Drive strategic and technical leadership in the development dosage forms supported by Carie Boyd. Built dosage industry trends strategic direction of non-sterile topicals, non-sterile transdermals, sterile injections and sterile pellets. RESULTS: Yield of 12 new dosage forms within one year in innovative 503B products.* Reduced unfocused direction of company's product line. Analyzed product design and identified improved materials, products and processes. RESULTS: Annual SKU increase of 300% in clinically needed 503B products.* Technical expert for all formulations and management of product development activities. Accomplished synergism of Rx manufacturing and 503A pharmacy. RESULTS: Generation of year over year batch size increase of 200X for liquid, powder and semisolid 503B products.* Originated development for both new products added to the daily queue and for new product lines that are more strategic and long-term in development. Coordinated with Quality team for the daily queue of corrective, preventive and improvement actions; coordinated with Operations team for new product line materials, products and processes. RESULTS: Full product pipeline for hospital and office 503B products. -
Independent ConsultantGuidepoint Sep 2019 - Apr 2021New York, Ny, UsPrimary Area of Expertise: HealthcarePrimary Industry: Pharmaceuticals & BiotechnologyPrimary Business Type: Pharmaceutical Manufacturer -
Executive ManagementFagron, Inc. Jun 2015 - Sep 2019Austin, Tx, UsChief Scientific Officer* Established entrepreneurial Humco Technical Operations leadership team. Developed business administration policies, comprehensive budget, goal setting and life cycle procedures for legal intellectual property. RESULTS: $70M acquisition by Fagron.* Participated in the stability testing programs related to an agent’s quality, consistency and stability. Assembled CMC team management, evaluating product specifications, packaging compatibility and pharmacovigilance. RESULTS: Completion of 280 stability studies.* Formulated the necessary ingredients and supplies for clinical-stage trial Supply Chain team management. Evaluated transdermal delivery and chemicals analysis data collection and data modeling. RESULTS: Delivery of 36 bioavailability studies and 15 GCP clinical studies.* Facilitated training and support to Quality team management. Finalized dermatology, hormone replacement and pain management operational management system, procedures, policies, core processes and objectives and key results (OKRs). RESULTS: 80% boost in cost controls, efficiency, process improvements and product quality standards.* Pioneered technique to take small molecule medicines and develop the formulations and manufacturing processes to transform them into new drug products. Convinced MS&T team management to fund engineering technologies. RESULTS: Cost savings of $450,000 per year.* Drove operational performance improvement through customer project management. Follow-up of assembly, change management, EHS and negotiation. RESULTS: $1.5M in sales to CVS and Walmart and 160% growth to Amazon and eBay. -
Senior Vice President Of Regulatory AffairsPharma Nobis Jun 2011 - Jun 2015Texarkana, Texas, UsQuality Assurance (QA) and Process Engineering* Envisioned the formulations needed to support tablet, capsule, injection, inhaler and topical agent administration methods and the manufacturing processes. Conducted needs analysis for validation documentation. RESULTS: Cost savings of $240,000 per year.* Launched major internal and external CMO manufacturers quality analyses. Identified potential areas of product complaints or reported quality issue to investigate for closure in accordance with company and external CAPA, efficiency, investigations, scheduling and six sigma guidelines and regulatory requirements. RESULTS: $1.9M savings in cost of goods. -
Vice PresidentPharma Nobis Jun 2007 - Jun 2011Texarkana, Texas, UsProduct Development (R&D)* Drive innovation program in startup markets. Built cannabis industry trends strategic direction of GenCanna isolates, MarketHub cosmetics and MedMen OTCs. RESULTS: Yield of $1.1M within one year in innovative cannabis product sales.* Reduced treatment period on drug products. Analyzed product design and identified improved materials of antibacterials, antimicrobials, antioxidants, hormones and humectants. RESULTS: Annual increase of $820,000 in dermatology product sales.* Facilitate market acceptance for pharmaceutical compounding products. Accomplished synergism of sustained-release transdermal development activities. RESULTS: Generation of 130% year over year revenue growth for cannabis and hormone products.* Originated design of unique multi-site product marketing program. Coordinated with product managers for rapid-release transdermal patent and publication content. RESULTS: Free claims for pain management and wound care products.
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Director Of QualityPharma Nobis Jun 2003 - Jun 2007Texarkana, Texas, UsAnalytical Operations (QC) * Established new product testing requirements and method validation. Used High Performance Liquid Chromatography (HPLC) and Ultra Performance Liquid Chromatography (UPLC). RESULTS: Production of new chemicals testing specifications for 100 pharmaceutical active vendors.* Influenced sterile production. Supervising USP<51> Challenge, USP<61> Enumeration, USP<62> Microorganisms, USP<71> Sterility, and USP<85> Endotoxins methods. RESULTS: Development activities of micro testing specifications for 250 API, excipients, and finished products in four years.
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Director Of Technical ServicesInterparfums May 1997 - Dec 2002Paris, Île-De-France, Fr* Built CMC team Chemicals goal to develop analytical validation plans of innovative materials, resulting in 21 hypoallergenic all natural materials to retailers such as CVS.* Increased CMC team Manufacturing goal to build process validation plans of OTC products, resulting in 15 national brand equivalent products to retailers such as Dollar General.* Received CMC team Controls goal to build regulatory validation plans of manufacturing processes, resulting in 60 observation free ISO processes to retailers such as Walmart. -
Research And Development ScientistMary Kay Global May 1991 - May 1997Addison, Tx, Us* Coordinated with R&D team to build product development plans that resulted in completion and evaluation of all product formulation results versus benchtop and market retail gold standards.* Achieved with Quality team to establish standards, quality control, and metrics criteria for organoleptic evaluation.* Produced with Regulatory team to develop testing schedules for accelerated stability testing program to evaluate sensory and quality parameters.* Identified with Clinical team to address unmet needs of promising areas of vendor research and technology activities.
John Trimble Skills
John Trimble Education Details
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Texas Christian UniversityChemistry -
Center Professional AdvancementEmulsion Suspension Technology
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Center Professional AdvancementDrug Product Stability Testing
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University Of Wisconsin-MadisonFormulation Development
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Waters InstrumentsHplc Method Development
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Project Management Institute
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Project Management Institute
Frequently Asked Questions about John Trimble
What company does John Trimble work for?
John Trimble works for Wells Pharma
What is John Trimble's role at the current company?
John Trimble's current role is SENIOR MANUFACTURING CONSULTANT.
What is John Trimble's email address?
John Trimble's email address is jt****@****ron.com
What is John Trimble's direct phone number?
John Trimble's direct phone number is +190383*****
What schools did John Trimble attend?
John Trimble attended Texas Christian University, Center Professional Advancement, Center Professional Advancement, University Of Wisconsin-Madison, Waters Instruments, Project Management Institute, Project Management Institute.
What skills is John Trimble known for?
John Trimble has skills like Gmp, Validation, Sop, Pharmaceutical Industry, Fda, Regulatory Affairs, Analytical Chemistry, Formulation, Hplc, Regulatory Requirements, Technology Transfer, Biotechnology.
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