Taylor Kwitny

DIRECTOR OF MANUFACTURING/ SENIOR PROJECT MANAGER

Manufacturing subject matter expert and senior project manager with nearly 20 years of experience across biotech, pharmaceutical, radiopharmaceutical, CDMO, diagnostic, medical-device, and other regulated manufacturing environments. Combines manufacturing leadership, operational excellence, technology transfer, qualification, and readiness experience with facility design and PMO expertise. Translates operational requirements into process flows, conceptual layouts, BOD/ URS inputs, equipment and utility requirements, budgets, schedules, risk controls, and executable implementation plans.

Facility Design and Manufacturing Integration Skills:

Facility and support-area planning; process and workflow development; personnel, material, product/ sample, equipment, and waste flows; master equipment and system lists; utility and infrastructure coordination; cleanroom, safety, and other operational considerations; BOD/ URS/ RFP development and review; design reviews; vendor and procurement support.

Project Delivery, PMO, and Operational Readiness Skills:

Scope definition; integrated schedules; ROM and budget reconciliation; risk, action, issue, change, and decision tracking; KPI dashboards; procurement inputs; stakeholder alignment; cross-functional facilitation; manufacturing readiness; PMO governance; commissioning and turnover support.

GMP, Qualification, and Operational Excellence Skills:

cGMP manufacturing; SOPs and batch records; deviation/ CAPA and root-cause investigations; microbial control; technology transfer; process validation; material, equipment, and facility qualification; training and OJT systems; tiered management; Lean/ Six Sigma; capacity planning and performance improvement.

• Supports PTSI facility design and project delivery programs by converting operational requirements into flow maps, BOD/ URS/ RFP content, equipment and utility inputs, budgets, schedules, vendor activities, and execution controls.

• Led operational improvements that supported four million units in one year, increased on-time delivery from 75% to 98%, and reduced overtime by 30% through capacity modeling.

• Designed facility upgrades and scalable manufacturing systems that improved capacity and quadrupled output.

• Led technology transfer, process validation, qualification, SOP development, facility upgrades, and cross-functional implementation in regulated manufacturing environments.

Credentials: MS Biotechnology | BS Human Biology | PMP | Six Sigma Black Belt