Director Manufacturing Support &Technology and Readiness

I started Renaissance Services to provide professional expertise to the health sciences industry. With a diverse technical background, I am able to deliver a variety of quality services to facilitate risk-based approaches that will ensure timely completion of projects throughout all phases of the validation lifecycle while meeting customer demands. With over 12 years of experience in Process Validation, facility start-up, technology transfer, regulatory filings, and audit support/responses, I… Show more I started Renaissance Services to provide professional expertise to the health sciences industry. With a diverse technical background, I am able to deliver a variety of quality services to facilitate risk-based approaches that will ensure timely completion of projects throughout all phases of the validation lifecycle while meeting customer demands. With over 12 years of experience in Process Validation, facility start-up, technology transfer, regulatory filings, and audit support/responses, I provide aid in the development and implementation of approaches, procedures, documents that are consistent with the expectations of the FDA and EU Process Validation life cycle. With a strong laboratory background, I offer knowledge and guidance to integrate new technologies to support a wide range of process and laboratory needs. I have over 20 years experience in the academic and pharmaceutical environments developing and delivering unique, tailored training to ensure colleagues gain the knowledge necessary for their professional development. Show less

Teach senior level course in Bioprocess Engineering program. This overview course covers a variety of topics including GMP overview, process validation, statistical process controls, computer validation, validation of temperature control units. Additionally, laboratories provided students with hands on experience in qualification of CTU’s and incubators by performing temperature mapping and open door testing of the units. Students were able to visit numerous sites to gain exposure to “real… Show more Teach senior level course in Bioprocess Engineering program. This overview course covers a variety of topics including GMP overview, process validation, statistical process controls, computer validation, validation of temperature control units. Additionally, laboratories provided students with hands on experience in qualification of CTU’s and incubators by performing temperature mapping and open door testing of the units. Students were able to visit numerous sites to gain exposure to “real world” manufacturing at solid dose and biopharmaceutical companies. Member of ECU Engineering Board of Advisors (2006-Present) Show less

• Provide leadership, direction and manage a diverse group of engineers responsible for production improvements, equipment qualification and validation, cleaning qualification and validation, manufacturing training, and problem solving analysis • Prepare departmental budget, and track spending and project deliverables against budget and project timelines • Work with functional leadership to ensure that the MT&S group is adequately staffed, roles and responsibilities are defined, and… Show more • Provide leadership, direction and manage a diverse group of engineers responsible for production improvements, equipment qualification and validation, cleaning qualification and validation, manufacturing training, and problem solving analysis • Prepare departmental budget, and track spending and project deliverables against budget and project timelines • Work with functional leadership to ensure that the MT&S group is adequately staffed, roles and responsibilities are defined, and projects are executed to timeline and budget • Provide leadership, direction and resources to support production activities including the execution of clinical and commercial production processes • Provide support and direction to the MT&S team to improve manufacturing effectiveness, including the cost to manufacture • Provide resources to maintain equipment in a validated state. Review and approve validation protocols and final reports, ensuring compliance with validation standard operating procedures, policies, cGMPs, and industry standards • Communicate equipment and operational constraints in relation to proposed timelines and in relation to existing projects • Interact professionally with customers, vendors and partners to effectively communicate operational issues, schedules, and status relevant to meeting project commitments • Develop staff skill levels, manage department skill gaps and actively seek to close those gaps • Adhere to all safety requirements and follow safe procedures, immediately notifying management or Safety when unsafe conditions or potential hazards are found; attend all required safety and health training, including handling hazardous waste, when necessary • Actively participate and show commitment to collaboration and sharing of best practices with internal/external SMEs and customers Show less

Provide fermentation/purification expertise to enhance and streamline production capacity and troubleshoot manufacturing issues with rapid, economical solutions. Supported the brewery in a variety of roles including manufacturing operations encompassing all aspects of brewing, cleaning, filling, retail operations, and sales. Aided with enhancing aseptic technics during manufacturing operations in order to minimize risk of contamination, developing better method/techniques for determining… Show more Provide fermentation/purification expertise to enhance and streamline production capacity and troubleshoot manufacturing issues with rapid, economical solutions. Supported the brewery in a variety of roles including manufacturing operations encompassing all aspects of brewing, cleaning, filling, retail operations, and sales. Aided with enhancing aseptic technics during manufacturing operations in order to minimize risk of contamination, developing better method/techniques for determining accurate yeast viability, evaluating process improvements to meet increased production demands with current fermentor capacity, and troubleshooting production issues. With knowledge gained, I have represented the brewery at a variety of public events in discussing the history of the brewery, manufacturing operations, distribution, and new products. Show less

Responsible for overseeing all Process Validation activities for protein production encompassing Buffer Prep, Media Prep, Fermentation and Purification manufacturing areas. Major projects have encompassed facilty start-up, downstream process opitmization, and media reformulation to improve protein yields.

Responsible for auditing and reviewing validation documentation including loop sheets, P&IDs, change control and design documents, protocols (IQ, OQ, PQ, ETP), SOPs, and Batch Production Records (BPRs) according to GMP/FDA guidelines. Authored Technical Registration Documents (TRDs) that summarize protocols and various validation documents for FDA review.

Responsible for developing/teaching undergraduate courses that emphasize application of analytical techniques to pharmaceutical analysis including instrument validation, sample preparation, and metabolite identification. Laboratory exercises included validation of an HPLC methods, isolation of compounds from biological samples and commercial beverages, and performing USP testing to evaluate the quality of pharmaceutical dosage forms.