Senior Program Officer, Drug-Devices CMC

Gates Foundation
Delhi
Workplace: OnsiteFull timeFunction: Solutions Engineering & Sales EngineeringExperience: 10+ yearsEducation: mastersSkills: ["Analytical thinking","Communications","Stakeholder management","Collaboration","Negotiation"]

Lead India-focused investments to improve the quality, manufacturability, regulatory readiness, and affordability of priority drug, device, and drug-device combination products supporting women’s health and MNCH outcomes. Manage grants and contracts, select and partner with CRO/CMO/CDMO and public-sector stakeholders, apply milestone-based go/no-go metrics, and provide CMC and cost-of-goods (COGS) guidance. Coordinate with teams in Seattle and the India Country Office to drive scalable execution.

Loading

Loading job details...

Preparing the role view and application actions.

FursaFursa
Gates Foundation
Gates Foundation
2 days ago

Senior Program Officer, Drug-Devices CMC

✓ Verified Job

Canonical indexed version, validated from employer's careers page.

Source: Company careers pageValidated by: Fursa AI
Last checked: 2 days agoStatus: Live

Job Summary

Lead India-focused investments to improve the quality, manufacturability, regulatory readiness, and affordability of priority drug, device, and drug-device combination products supporting women’s health and MNCH outcomes. Manage grants and contracts, select and partner with CRO/CMO/CDMO and public-sector stakeholders, apply milestone-based go/no-go metrics, and provide CMC and cost-of-goods (COGS) guidance. Coordinate with teams in Seattle and the India Country Office to drive scalable execution.
Location: Delhi
Workplace: Onsite
Employment Type: Full time
Job Function: Solutions Engineering & Sales Engineering
Seniority: Mid level

Key Responsibilities

  • •Design, structure, and manage grants and contracts for drug, device, and drug-device combination product development with strong CMC plans, scale-up pathways, and clear deliverables.
  • •Identify and select partner institutions (industry, academia, CRO/CMO/CDMO networks, and public-sector partners) and shape scope and strategy to meet development readiness, quality-systems, and scalable manufacturing goals.
  • •Apply milestone-based performance metrics and support go/no-go decisions, including diligence of feasibility, manufacturing readiness, regulatory risk, and cost targets.
  • •Provide technical and strategic CMC guidance to grantees and contractors, including progress on Drug Substance (DS) and Drug Product (DP) where relevant and COGS/cost-reduction progress.
  • •Collaborate with Seattle and India Country Office teams to connect CMC, regulatory, and product strategy and influence partner execution plans.
Travel: Medium travel

Pay and Benefits

Perks:Health InsuranceDentalVisionPaid Leave

Key Requirements

  • •Master’s or PhD in Science or Engineering or a related field.
  • •Minimum 10 years of experience in a pharmaceutical, biotechnology, or medical device company (including CMO/CDMO settings) with hands-on CMC depth.
  • •Experience with formulation and/or API process development, analytical chemistry and method validation, GMP manufacturing and scale-up, process validation, regulatory submissions, and quality systems.
  • •Direct product experience in women’s health and/or maternal, neonatal, and child health, including how CMC/manufacturing choices affect commercialization.
  • •Proven ability to manage technology transfer and manufacturing scale-up through CMO/CDMO partnerships and resolve supply/capacity constraints.
Experience:10+ yearsPharmaceuticalBiotechnologyMedical devicesCMO/CDMOWomen's healthLMICs
Education:Master's in Science or Engineering
Skills:Analytical thinkingCommunicationsStakeholder managementCollaborationNegotiation
Tech Stack:CMCChemistry, Manufacturing, and ControlsGMPProcess validationAnalytical chemistryMethod validationDS/DPCOGS modelingTechnology transferICH-aligned quality expectationsWHO-linked pathwaysCROCMOCDMOICMRCDSCO

Eligibility

Work Authorization:Authorization required. Sponsorship not provided.

Company Brief

Gates Foundation
A philanthropic organization that funds global health, development, education, and policy initiatives to reduce inequity and improve quality of life worldwide through grants, partnerships, and evidence-based programs.
Industry: Nonprofit
Company Size: Enterprise (1,001+ employees)
Revenue: USD 1B+
Growth: Nonprofit & NGO
Funding: Grant Funded
Headquarters: Seattle, United States
Founded: 2000
WebsiteLinkedIn