Senior Program Officer, Drug-Devices CMC

The Foundation We are the largest nonprofit fighting poverty, disease, and inequity around the world. Founded on a simple premise: people everywhere, regardless of identity or circumstances, should have the chance to live healthy, productive lives. We believe our employees should reflect the rich diversity of the global populations we aim to serve. We provide an exceptional benefits package to employees and their families which include comprehensive medical, dental, and vision coverage with no premiums, generous paid time off, paid family leave, foundation-paid retirement contribution, regional holidays, and opportunities to engage in several employee communities. As a workplace, we’re committed to creating an environment for you to thrive both personally and professionally. The Team The India Country Office (ICO) is central to the foundation’s commitment to advancing equitable health outcomes and strengthening India’s health innovation ecosystem. The Health R&D Cluster is a core enabler of the ICO’s key goals across our portfolio. The cluster advances R&D and innovation across foundational research; medical devices, vaccines, and drugs, as well as data-science methods (modeling, AI-enabled tools). We approach this by accelerating R&D and the deployment of affordable, high-quality, accessible products, working with the Government of India - at central and state level, academia, industry, and global networks. Your Role As a Senior Program Officer, Drug-Devices CMC , you will play a critical role in shaping and managing a portfolio of India-focused investments to ensure quality, manufacturability, regulatory readiness, and affordability of priority drugs, devices, and drug-device combination products that advance women’s health innovation (WHI) and maternal, neonatal, and child health (MNCH) outcomes. The portfolio includes programs such as Hormonal IUD (intrauterine device), heavy menstrual bleeding therapeutics, implants, novel contraceptives, and maternal & neonatal therapeutics. The postholder will collaborate with internal and external partners to drive innovative solutions, making sure products are designed for scale, validated for performance, and progressed through robust Chemistry, Manufacturing, and Controls (CMC) plans and fit-for-purpose quality systems. You will bring expertise spanning product development, CMC strategy, manufacturing scale-up and tech transfer, regulatory pathways (including combination products), and cost of goods (COGS) modeling and cost-reduction enabling strategies helping ensure products can be sustainably manufactured and adopted in public health programs. The role is based and reports to the foundation’s ICO in New Delhi , and reports to a senior manager supporting WHI and MNCH product development and deployment. What You’ll Do This is a highly collaborative leadership role requiring strategic engagement with multiple Program Strategy Teams (PSTs) in Seattle and teams across the ICO, for new product development, scaling, and portfolio optimization. In this role you will: Design, structure, and manage critical grants and contracts for drug, device, and drug-device combination product development-ensuring strong CMC plans, realistic scale-up pathways, and clear deliverables Identify and select partner institutions (e.g. industry, academia, Contract Research Organization (CRO)/ Contract Manufacturing Organization (CMO)/Contract Development and Manufacturing Organization (CDMO) networks, and public-sector partners) and shape scope and strategy for selected grants and contracts to meet strategic goals especially around development readiness, quality systems, and scalable manufacturing. Apply milestone-based performance metrics and help with go/no-go decision-making, including technical and commercial diligence of feasibility, manufacturing readiness, regulatory risk, and cost targets. Provide technical and strategic support to grantees and contractors guiding CMC strategy (Drug Substance (DS)/Drug Product (DP) where relevant) and COGS/cost-reduction progress. Collaborate closely with foundation teams in Seattle and ICO connecting CMC, regulatory, and product strategy to program objectives and influence partner execution plans. Your Experience Master’s or PhD in Science or Engineering or related fields is required. Minimum of 10 years’ experience within a pharmaceutical, biotechnology, or medical device company (including CMO/CDMO settings), with hands-on depth across the CMC functions - formulation and/or API process development, analytical chemistry and method validation, GMP manufacturing and scale-up, process validation, regulatory submissions, and quality assurance and quality systems with preference for experience in India and/or Low and Middle-Income Countries (LMICs) contexts. Direct product experience in women’s health and/or maternal, neonatal, and child health, with an understanding of how CMC and manufacturing choices shape the commercialization pathway in these categories. Proven ability to manage technology transfer and manufacturing scale-up through CMO/CDMO partnerships - establishing control strategies, assessing site readiness, and resolving supply and capacity constraints. Experience in evaluating and optimizing COGS models and driving sustainable cost reduction via multi-faceted process optimization, yield improvements, raw material and supplier optimization, packaging innovation, and analytical design, while ensuring unwavering quality and regulatory compliance Advanced portfolio and program management skills with a track record of successfully structuring, overseeing, and strategically directing large-scale, high-value grants and contracts advancing product development, manufacturing readiness, and organizational mission impact Familiarity with India’s health product policy ecosystem and experience working with relevant agencies (such as ICMR, CDSCO) and comfort navigating global expectations where relevant (e.g., ICH-aligned quality expectations, WHO-linked pathways). Excellent analytical thinking and communications skills, including the ability to synthesize evidence into actionable insights, prepare high-quality briefings and analyses for leadership, and public speaking. Demonstrated ability to lead and influence in highly matrixed, complex organizational environments, with exceptional collaboration, consultative, negotiation, and stakeholder management skills, building strategic partnerships across technical, commercial, and governmental constituencies Growth mindset - curious about innovative approaches, able to change direction, willing to seek feedback and course correct. Results-driven and self-motivated with ability to inspire the pursuit of excellence. Other Attributes Comfortable in a wide range of cultural, geographic and operational situations, demonstrating culturally sensitive behaviour with a diverse range of people and a deep commitment to development issues and high standards of personal integrity. Willingness to travel up to 30% of the time. *Must be able to legally work in the country where this position is located without visa sponsorship. Application deadline: 20 September 2026 #LI-RT1 Hiring Requirements As part of our standard hiring process for new employees, employment will be contingent upon successful completion of a background check. Candidate Accommodations We’re committed to providing an inclusive and accessible hiring experience for all candidates. If you have a disability or medical condition and need an accommodation at any stage of the application or interview process—such as an ASL interpreter, alternative interview format, or physical accessibility support—we’re happy to help. Please contact with the position number and a brief description of your accommodation needs. Requests will be handled confidentially. Inclusion Statement We are dedicated to the belief that all lives have equal value. We strive for a global and cultural workplace that supports ever greater diversity, equity, and inclusion — of voices, ideas, and approaches — and we support this diversity through all our employment practices. All applicants and employees who are drawn to serve our mission will enjoy equality of opportunity and fair treatment without regard to race, color, age, religion, pregnancy, sex, sexual orientation, disability, gender identity, gender expression, national origin, genetic information, veteran status, marital status, and prior protected activity.