Senior Scientist - Formulation & Quality Leadership

David Goff

Senior Scientist

Email: *********@*****.*** Phone: 260-***-**** Location: Toledo, OH

Professional Summary

Results-driven Formulation Quality Manager with 20+ years of expertise in product development, quality control, and regulatory compliance. Specialized in developing innovative formulations across pharmaceutical, cleaning, and nutritional product categories. Experienced in leading cross-functional teams, managing laboratory operations, and ensuring compliance with FDA, EPA, GMP, USP, and ISO standards. Proven track record of successfully bringing new products from concept to market while maintaining rigorous quality standards. Core Competencies

Product Development: Formula creation, bench to scale-up, stability testing, technology transfer, formulation optimization, new product development

Quality Assurance: Quality control, compliance validation, CAPA implementation, batch record review, process improvement, regulatory compliance Laboratory Analysis: FTIR, UV Spectrophotometry, HPLC, GC analysis, microbiological testing, analytical method development, cytotoxicity evaluation Regulatory Compliance: FDA regulations, EPA compliance, GMP standards, GLP protocols, ISO certification, USP guidelines, OSHA requirements, DEA compliance Technical Skills: Product characterization, performance evaluation, equipment qualification, validation protocols, environmental monitoring, aseptic manufacturing Leadership: Team management, technical training, project management, cross-functional collaboration, staff supervision

Professional Experience

Chemist

INCEPTOR, INC. Toledo, OH 2022-2025 (Company closing)

- Conduct comprehensive quality testing and manufacturing verification to ensure product compliance with specifications

- Develop and optimize new formulations to meet market demands and customer requirements

- Implement analytical methods for product characterization and performance evaluation

- Collaborate with manufacturing teams to facilitate successful production scale-up

- Ensure regulatory compliance and quality standards throughout product development lifecycle Senior Formulation Chemist / Product Development Manager CANBERRA CORPORATION Toledo, OH 2014-2021

- Led team of scientists in developing custom cleaning products, resulting in multiple new product launches

- Performed advanced laboratory analysis using FTIR and UV Spectrophotometry to characterize product performance

- Served as key member of Quality Control Unit, implementing process improvements that reduced non-conformances by 25%

- Ensured regulatory compliance through comprehensive review of product specifications and labeling requirements

- Managed multiple development projects simultaneously while maintaining strict quality standards

- Supervised formulation development from concept through commercialization Product Development Specialist

UCKELE HEALTH & NUTRITION Blissfield, MI 2013-2014

- Formulated nutritional supplements for human and animal markets

- Directed management of entire Zephyr's Garden topical product line

- Conducted rigorous label reviews to ensure compliance with FDA and NASC regulations

- Coordinated with manufacturing and marketing teams to ensure successful product launches

- Developed formulations meeting regulatory requirements and market specifications Senior Microbiologist

LEXAMED Toledo, OH 2011-2012

- Provided expert consultation to third-party companies on cleaning, disinfection, and sterilization of medical devices

- Performed laboratory analyses including cytotoxicity evaluation on medical products

- Operated and analyzed Steam-BIER and Ethylene Oxide-BIER systems for validation purposes

- Conducted GC analysis of residual Ethylene Oxide to ensure product safety and regulatory compliance

- Executed IQ/OQ protocols for equipment qualification and validation

- Maintained compliance with medical device regulations and safety standards Formulation Chemist

SUN PHARMACEUTICAL INDUSTRIES Bryan, OH 2006-2011

- Developed and optimized formulations for pharmaceutical products, contributing to 10+ successful product launches

- Prepared and reviewed standard operating procedures for Research and Development Department

- Supervised batch manufacturing in R&D and manufacturing departments to ensure consistency and quality

- Coordinated technology transfer to manufacturing departments and third-party manufacturers

- Participated in FDA audit proceedings and successfully addressed regulatory deficiencies

- Managed DEA inventory compliance and hazardous waste management for facility

- Maintained GMP compliance throughout all development and manufacturing processes Research Scientist

KP PHARMACEUTICAL TECHNOLOGY Bloomington, IN 2004-2006

- Conducted R&D manufacturing of oral and parenteral drug products from formulation through QC analysis

- Developed formulations for multiple pharmaceutical delivery systems including oral dosage forms, parenteral dosage forms, topical creams and ointments, and ophthalmic emulsions and suspensions

- Performed environmental monitoring of Class 10,000 and Class 100 Clean Rooms

- Conducted analytical testing including endotoxin analysis, coulometer analysis, liquid particle count, TOC analysis, pH analysis, HPLC analyses, and UV Spectrophotometer analysis

- Trained and supervised laboratory personnel on equipment operation and aseptic manufacturing techniques

- Ensured compliance with pharmaceutical manufacturing regulations and quality standards Education

Bachelor of Science, Liberal Sciences - Microbiology Indiana University, Bloomington, IN

Honors Program

Certifications and Training

- GMP Training and Compliance

- FDA Regulatory Requirements

- Laboratory Safety and OSHA Standards

- Quality Management Systems

- Aseptic Manufacturing Techniques

- Hazardous Waste Management (not current)

- First Aid, CPR, AED

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