Nick Myslinski

•Led R&D, supply chain, and cGMP manufacturing activities for CTx-1301, Cingulate’s innovative multi-stage release drug product, overseeing production of Engineering batches, Phase 3 clinical supply, and pivotal Registration batches for NDA submission. •Orchestrated the seamless tech transfer of manufacturing processes between CDMOs, enhancing equipment and process efficiency, and facilitating the manufacturing scale-up from proof of concept to full-scale commercial capacity. •Acted as Subject Matter Expert (SME) for all CMC activities, authoring development reports and regulatory filings, managing the evaluation and collaboration with CDMOs, equipment vendors, suppliers, and optimization of current & future manufacturing processes. •Designed and executed experiments for pipeline drug products, identifying critical formulation and manufacturing process parameters, and utilizing methodologies such as DOE and PAT to ensure the highest-quality production and process optimization from the first batch. •Drove the exploration and incorporation of novel technologies, assessing their impact on manufacturing operations; collaborated with internal departments and external vendors to implement process changes and enhance productivity.

•Provided engineering expertise and oversaw project management for the construction of cutting-edge genetic therapy research and development facilities. Responsibilities encompassed procurement and negotiation of quotes, production of CAD and engineering drawings, assessment of utility requirements and suitability, and equipment procurement, installation, qualification, and validation. • Supported troubleshooting endeavors for utilities, equipment, and systems to ensure the operational robustness of processes across R&D, Manufacturing, and Lab Operations. • Facilitated seamless coordination among various functions, departments, and construction teams, fostering effective collaboration across facility personnel in a fast-paced environment. • Led and cultivated a high-performing team, overseeing recruitment, performance evaluations, and professional growth initiatives. Aligned departmental objectives with broader functional and corporate goals.

•Lead for large-scale capital investment projects for a biologics manufacturing facility including equipment design/development, preparation of specifications, bid package negotiations, engineering drawing production, and overall project management. •Developed a 5-year Site Master Plan resulting in the expansion of current site footprint to meet increased manufacturing demand •Established and maintained a predictive maintenance program for new, GMP facility critical systems and high-value process equipment •Developed and managed the annual site CAPEX budget and worked as the site liaison for the corporate Finance department

• Collaborated with clients to align technology transfer, process engineering, qualification (DQ, IQ, OQ, PQ), validation/PPQ goals to their specific requirements. Led ongoing continuous improvement initiatives aimed at consistently optimizing operations. • Authored batch records, SOPs, change controls, CAPAs, deviations/failure investigations, qualification and validation protocols, Design of Experiment (DoE) matrices, and job quotations. • Managed a formulation development lab, aiding clients in production of new dosage forms, troubleshooting manufacturing issues, and lab-scale experimentation. • Led a team of high-performing manufacturing engineers, overseeing daily production operations, assessing skill sets for optimal assignments, and fostering professional development opportunities. • Proficient in FDA Title 21 CFR Part 11/210/211, ICH, MHRA, and EU GMP guidelines and validation practices.

• Managed daily production of a commercial-scale extrusion process, annually generating 125M dosage units and $300M+ in revenue. Directly responsible for product quality, maximizing yield, limiting process downtime, and personnel oversight. • Coordinated procurement of cGMP pharmaceutical equipment, including quote solicitation, design qualifications, and CAPEX considerations. • Established a drug development program, resulting in the creation and patenting of several novel IR and ER dosage platforms. • Proficient in the FDA drug development process, encompassing IND application through commercial launch, including CMC authoring.

• Responsible for production of solid, semi-solid, and liquid-filled GMP pharmaceutical drug products. • Execution of electronic batch records, manufacturing protocols, and packaging/labeling studies.