Senior Program Officer, Drug-Devices CMC

Job Posting Organization:
The organization is the largest nonprofit dedicated to combating poverty, disease, and inequity globally. Founded on the principle that everyone deserves the opportunity to lead healthy and productive lives, the foundation emphasizes the importance of diversity among its employees to reflect the populations it serves. It offers a comprehensive benefits package that includes medical, dental, and vision coverage without premiums, generous paid time off, paid family leave, retirement contributions, regional holidays, and opportunities for employees to engage in various communities. The foundation is committed to fostering an environment that supports both personal and professional growth.

Job Overview:
As a Senior Program Officer for Drug-Devices CMC, you will be instrumental in managing a portfolio of investments focused on ensuring the quality, manufacturability, regulatory readiness, and affordability of priority drugs, devices, and drug-device combination products aimed at improving women's health innovation and maternal, neonatal, and child health outcomes. This role involves collaboration with various stakeholders, including government entities, academia, and industry, to drive innovative solutions and ensure that products are designed for scalability and validated for performance. You will leverage your expertise in product development, CMC strategy, and regulatory pathways to facilitate the sustainable manufacturing and adoption of health products in public health programs.

Duties and Responsibilities:
In this leadership role, you will engage strategically with multiple Program Strategy Teams (PSTs) in Seattle and across the India Country Office (ICO) to oversee new product development and portfolio optimization. Your responsibilities will include designing and managing grants and contracts for drug and device development, ensuring robust CMC plans and clear deliverables. You will identify and select partner institutions, shape grant scopes, and apply milestone-based performance metrics to guide decision-making. Additionally, you will provide technical and strategic support to grantees and contractors, ensuring alignment with CMC strategy and cost-reduction efforts. Collaboration with foundation teams will be essential to connect CMC, regulatory, and product strategies to program objectives.

Required Qualifications:
Candidates must possess a Master's or PhD in Science, Engineering, or related fields, along with a minimum of 10 years of experience in the pharmaceutical, biotechnology, or medical device sectors. This experience should encompass hands-on involvement in CMC functions, including formulation development, analytical chemistry, GMP manufacturing, and regulatory submissions. Preference will be given to candidates with experience in India or Low and Middle-Income Countries (LMICs). Direct product experience in women's health and maternal, neonatal, and child health is essential, as is a proven ability to manage technology transfer and manufacturing scale-up through partnerships with CMOs and CDMOs.

Educational Background:
A Master's or PhD in Science, Engineering, or a related field is required for this position. This educational background is critical to ensure that candidates have the necessary technical knowledge and skills to effectively contribute to the development and management of health products.

Experience:
The position requires a minimum of 10 years of relevant experience within the pharmaceutical, biotechnology, or medical device industries. Candidates should have a deep understanding of CMC functions and experience in managing product development and manufacturing processes, particularly in the context of women's health and maternal, neonatal, and child health.

Languages:
While the job description does not specify mandatory languages, proficiency in English is likely essential given the international nature of the organization and its operations. Additional language skills may be beneficial, particularly in local languages relevant to the Indian context.

Additional Notes:
This position is based in New Delhi, India, and requires the ability to legally work in the country without visa sponsorship. The role may involve travel up to 30% of the time. The application deadline is set for 20 September 202

• The organization emphasizes a commitment to diversity, equity, and inclusion in its hiring practices, ensuring that all candidates are treated fairly and equitably regardless of their background.