Jacob Thieman Email & Phone Number

Cary, NC, US

North Carolina, United States

• Consistently lead root cause analysis for laboratory investigations, Out-of-Specification (OOS) results, and Corrective and Preventive Actions (CAPA) from a technical perspective, collaborating closely with the Quality.
• Oversee technical communication with customers for projects spanning drug development and cGMP Phase 3 studies, managing up to six concurrent customer projects while ensuring alignment with regulatory requirements.
• Led the execution of validation and stability studies in compliance with cGMP regulations, ensuring adherence to FDA guidelines and facilitating the successful development and registration of pharmaceutical products.
• Independently develop formulations and associated characterization methods for various inhaled and nasal dosage forms, including metered dose inhalers, dry powder inhalers, nasal sprays, soft mist inhalers, and.
• Actively participate in Good Laboratory Practice (GLP) studies, ensuring compliance with regulatory standards and maintaining high-quality data integrity for accurate evaluation of pharmaceutical products.
• Manage the workload of over five analysts weekly while also overseeing direct reports, fostering a collaborative team environment to enhance productivity.

• Consistently lead root cause analysis for laboratory investigations, Out-of-Specification (OOS) results, and Corrective and Preventive Actions (CAPA) from a technical perspective, collaborating closely with the Quality.
• Oversee technical communication with customers for projects spanning drug development and cGMP Phase 3 studies, managing up to six concurrent customer projects while ensuring alignment with regulatory requirements.
• Led the execution of validation and stability studies in compliance with cGMP regulations, ensuring adherence to FDA guidelines and facilitating the successful development and registration of pharmaceutical products.
• Independently develop formulations and associated characterization methods for various inhaled and nasal dosage forms, including metered dose inhalers, dry powder inhalers, nasal sprays, soft mist inhalers, and.
• Actively participate in Good Laboratory Practice (GLP) studies, ensuring compliance with regulatory standards and maintaining high-quality data integrity for accurate evaluation of pharmaceutical products.
• Manage the workload of over five analysts weekly while also overseeing direct reports, fostering a collaborative team environment to enhance productivity.

• Provide training for all new hires and current analysts in formulation and inhalation processes, focusing on documentation practices, instrumentation, laboratory techniques, and analytical methodologies to ensure.
• Prepare and review critical documents, including test methods, protocols, laboratory investigations, and validation reports, ensuring alignment with cGMP regulations and FDA guidelines.
• Oversee cGMP laboratory operations in strict compliance with FDA regulations and Good Laboratory Practices (GLP), ensuring high-quality data integrity and adherence to industry standards.
• Contribute to the authorship of sections in stability protocols and reports, deviations, laboratory investigations, invalid data events, root cause analyses, change controls, and other quality system procedures.

Durham, North Carolina, United States

• Conduct inhalation and formulation development, validation, release, and stability time-point testing while ensuring high-quality laboratory documentation in a cGMP and GLP environment, in compliance with FDA.
• Specialize in aerodynamic particle size distribution, droplet size distribution, and delivered dose testing for metered dose inhalers, nasal sprays, and nebulizers, employing advanced analytical techniques to ensure.
• Develop active pharmaceutical ingredient (API) and placebo batch formulations for release and stability time-point testing, utilizing best practices to support regulatory submissions and enhance product quality.

Wilmington, North Carolina, United States

• Assisted undergraduates with instrumentation, data analysis, and safe lab etiquette
• Maintained a working lab environment that was free of contamination to work at micromolar concentrations
• Conducted routine lab maintenance, calibrated equipment, managed waste, and organized orders

Wilmington, North Carolina Area

• Collectively instructed up to 120 undergraduate students per semester in General Chemistry and Senior level Instrumental Chemistry
• Received the Graduate TA award for excellence in teaching General Chemistry Lab
• Helped in the design of new labs during the switch to online labs

Master Of Science - Ms With A Concentration In Inorganic Chemistry, Chemistry

• Synthesized and developed fluorescent sensors for selective complexation of metal ions and anions • Operated a spectrofluorometer and.

Bachelor Of Arts - Ba, Chemistry

I performed a Directed Independent Study for 3 semesters under Dr. Sridhar Varadarajan. For this research I synthesized and developed.