Program Officer, Drug-Devices

Job Posting Organization:
The Foundation is the largest nonprofit organization dedicated to fighting poverty, disease, and inequity on a global scale. Established with the mission that every individual, regardless of their identity or circumstances, should have the opportunity to lead a healthy and productive life, the Foundation emphasizes the importance of diversity among its employees to reflect the global populations it serves. The organization offers a comprehensive benefits package that includes medical, dental, and vision coverage without premiums, generous paid time off, paid family leave, retirement contributions funded by the foundation, regional holidays, and opportunities for employees to engage in various community initiatives. The Foundation is committed to fostering an environment that supports both personal and professional growth for its employees.

Job Overview:
As a Program Officer for Drug-Devices, you will be instrumental in shaping and managing a portfolio of investments focused on India. Your primary responsibility will be to ensure the quality, manufacturability, regulatory readiness, and affordability of priority drugs, devices, and drug-device combination products that aim to enhance women's health innovation and improve maternal, neonatal, and child health outcomes. The portfolio encompasses various programs, including hormonal IUDs, treatments for heavy menstrual bleeding, therapeutics, implants, novel contraceptives, and maternal and neonatal therapeutics. You will collaborate with both internal and external partners to drive innovative solutions, ensuring that products are designed for scalability, validated for performance, and advanced through robust Chemistry, Manufacturing, and Controls (CMC) plans and quality systems that are fit for purpose. Your expertise will span product development, CMC strategy, manufacturing scale-up, regulatory pathways, and cost modeling, all aimed at ensuring sustainable manufacturing and adoption in public health programs.

Duties and Responsibilities:
In this collaborative role, you will work closely with multiple Program Strategy Teams (PSTs) in Seattle and teams across the India Country Office (ICO) to facilitate new product development and scaling. Your specific duties will include designing, structuring, and managing critical grants and contracts for the development of drug, device, and drug-device combination products, ensuring that strong CMC plans are in place, realistic scale-up pathways are established, and clear deliverables are defined. You will identify and select partner institutions, such as industry, academia, and various organizations, shaping the scope and strategy for selected grants and contracts to meet strategic goals, particularly regarding development readiness, quality systems, and scalable manufacturing. Additionally, you will apply milestone-based performance metrics to assist in go/no-go decision-making, providing technical and strategic support to grantees and contractors while guiding CMC strategy and cost-reduction progress. Collaboration with foundation teams in Seattle and ICO will be essential to connect CMC, regulatory, and product strategy to program objectives and partner execution plans.

Required Qualifications:
Candidates must possess a Master’s or PhD in Science, Engineering, or related fields. A minimum of 10 years of experience is required, with a preference for candidates who have worked in pharmaceutical and/or combination product development, CMC, manufacturing sciences, and regulatory affairs, particularly within India and/or Low and Middle-Income Countries (LMICs). A strong understanding of CMC and manufacturing processes within the product development and commercialization pathway is essential, especially concerning regulatory requirements in the women’s health and maternal/child health sectors. Experience in manufacturing scale-up through CMO/CDMO tech transfer, process characterization, control strategy development, and GMP readiness is also necessary. Candidates should have portfolio and project management skills, with the ability to structure, oversee, and review large-scale grants and contracts that advance product development and manufacturing readiness.

Educational Background:
The position requires a Master’s or PhD in Science, Engineering, or a related field. This educational background is crucial for understanding the complexities involved in drug and device development, as well as the regulatory landscape that governs these processes.

Experience:
The ideal candidate should have at least 10 years of relevant experience, particularly in the fields of pharmaceutical and combination product development, CMC, manufacturing sciences, and regulatory affairs. Experience in India and/or LMIC contexts is preferred, as it provides valuable insights into the unique challenges and opportunities present in these environments. Candidates should also have a proven track record of managing projects and portfolios effectively, demonstrating their ability to navigate complex regulatory landscapes and drive product development initiatives.

Languages:
Proficiency in English is mandatory, as it is the primary language of communication within the organization and for documentation purposes. Knowledge of additional languages, particularly those relevant to the Indian context, would be considered an asset, enhancing communication with local partners and stakeholders.

Additional Notes:
This position is based in New Delhi and requires the candidate to be legally eligible to work in India without visa sponsorship. The role may involve travel up to 30% of the time to engage with partners and stakeholders. The application deadline for this position is set for 20 February 202

• The Foundation is committed to diversity, equity, and inclusion in its hiring practices, ensuring that all applicants are treated fairly and without discrimination.