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 rare inherited disorder.As head of a matrixed CMC team, and in close collaboration with internal and external stakeholders, I steered the Phase I/II and Phase III program through process development, quality, regulatory, manufacturing, and clinical supply chain. I leveraged my passion for bringing innovative therapies to patients—together with decision-making and roll-up-your-sleeves leadership—to make a positive impact at every stage of the global project.I managed people and budgets with rigorous requirements and deadlines, identifying and mitigating risk along the way.CMC strategy and execution for on-time, on-target deliverables:• 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 decision-making:• 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, simplified drug handling at trial sites, and will certainly add future value for healthcare providers and patients.

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 pharmaceutical programs throughout of the product lifecycle. The work was both successful and rewarding. It involved leadership, strategic decision-making, and effectively managing and delivering on regulatory touchpoints for a large portfolio of products. Within six months of joining the company, my role expanded and I took on responsibilities as leader and mentor of direct-reports.What did I add to Merck’s CMC regulatory management and problem solving?• 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 program success.

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 accelerating medicines and devices (combination products) from early development through global regulatory approval, launch, and lifecycle management.In order to balance the needs of the organization with those of patients around the world, I shaped strategy, created budgets, and crafted long-term strategic plans. I also served as a trusted resource for executive management, advising on risks and assisting with strategic decisions.Working closely with diverse teams and stakeholders, I contributed to the discovery, development, and commercialization of life-saving and life-improving therapies for patients around the world.Highlights of CMC leadership across the product lifecycle:• 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.• Led biosimilar project with speed, accuracy, and accountability.• Motivated and mentored matrix CMC teams in North America, Europe, Asia, and other international markets.

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 allergic reactions. I led and motivated a team of up to eight analytical chemists in developing, testing, and facilitating strategic decision-making for the Epinephrine.I managed the complexities of this high-profile program, which involved comprehensive CMC matrix leadership for an unstable product in an autoinjector device.Contract manufacturing organization (CMO) management and partnership:• 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.• Defined and optimized specifications for the autoinjector including CIPCs and CPPs for PFS, such as stopper height measurements, bubble size, and impact on delivery volume. Managed CT scans, optimized testing methodology, etc.• Directed a broad range of studies to assess stability, compatibility and in-use studies, extractables, and leachables.• Led technical experts to ensure formulation robustness: identify, isolate, and characterize unknown degradants; qualify impurities; and optimize process conditions.• Teamed with the business development partner to close out deficiencies to the Master Access File.

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.