Rowena D'Mello, Phd, Pmp Email & Phone Number

Kennett Square, PA, US

Cambridge, Massachusetts, United States

Brisbane, California, United States

• I created and executed CMC strategies to support clinical milestones and accelerate commercialization of late-stage gene therapy products. In this role, I led the flagship program for patients with Fabry disease, a.
• Pioneered comprehensive CMC strategies and approaches that aligned with regulatory requirements, project timelines, and business goals.
• Steered end-to-end CMC activities including CMO site selection, tech transfer, formulation development, batch manufacturing, quality and comparability testing, etc.
• Navigated complex global regulatory requirements and submissions, and collaborated with CMC Regulatory to influence endorsements on submission strategy from the FDA, EMA, and PEI and facilitate approvals.Proactive.
• Resolved critical supply chain challenges by diving in deeply—and quickly—and by working with cross-functional teams to expedite manufacturing, track raw materials, and circumvent potential delays.
• Orchestrated a seamless transition from Phase I/II to Phase III and commercial manufacturing, including changing manufacturing sites, scale-up, and formulation changes. This proactive effort dramatically reduced costs.

Upper Gwynedd, Pennsylvania, United States

• I joined Merck with a clear goal in mind: to help the company while gaining firsthand experience in global regulatory affairs. In this high-impact position, I developed and implemented CMC regulatory strategies for.
• Wrote and reviewed CMC components of global regulatory submissions.
• Provided regulatory leadership and compliance management for special initiatives: due diligence of potential in-licensed products, and exploring the impacts of asset divestment or withdrawal.
• Fostered collaboration with the internal manufacturing division as well as external partners.
• Facilitated global efforts—across continents, cultures, and time zones.In addition, I pinpointed and succinctly communicated regulatory risks. I proposed mitigation strategies and showcased my proactive approach to.

West Chester, Pennsylvania, United States

• Earned a promotion to steer CMC strategies for biologics and biosimilar programs—reaching patients with diverse therapeutic needs: oncology, pain, migraine, and severe respiratory challenges. I led a matrix team in.
• Planned and optimized manufacturing efforts via pFMEA, dFMEA, etc.
• Wrote key sections of IND, BLA, and MAA submissions.
• Provided information and insights to regulatory authorities—including responding to inquiries.
• Managed an accelerated path to market for Ajovy (fremanezumab) injection and autoinjector—with competitors on its heels.
• Headed LCM efforts for Cinqair (reslizumab) injection for severe asthma.

Pomona, New York, United States

• Promoted to Principal Researcher (a CMC leadership and project management role) within 18 months in recognition of standout contributions to Teva’s high-profile Epinephrine project, designed to treat life-threatening.
• Established an onsite presence at the CMO site in Indiana, fostering real-time planning, collaboration, and issue resolution.
• Developed processes for the handling and storage of both raw materials and components.
• Worked shoulder-to-shoulder with CMO leaders and stakeholders to draft project plans, technical documents, and quality / supply chain agreements.CMC leadership and technical subject matter expertise:
• Coordinated all CMC efforts from analytical activities through regulatory approval.
• Became the departmental SME in the autoinjector device after diving deeply into the technology and traveling to the global R&D group in the UK.

Bedford, OH

I believe that my early-career roles as a scientist and chemist provided the groundwork for success in CMC matrix leadership. In this position, I led the development, validation, and transfer of analytical methods for API and drug formulation projects. I also contributed to regulatory filings.

Ontario, Canada

Supported formulation development and manufacturing of solid oral pharmaceutical products.