Senior Program Officer, Chemistry, Manufacturing and Controls

Job Description

We believe that energized people, working well together, fueled by great leadership in an inclusive environment in which they thrive, will do phenomenal things.Division SummaryOur efforts are aligned with India s objectives of improving the lives of its people -- working closely with India s Central and State governments, we partner with community groups, nonprofit organizations, academic institutions, the private sector, and development organizations, to achieve our shared goals. Our strong networks and ability to convene intellectual resources from many every sectors and every regions of the globe allows us to address complex challenges as they emerge or evolve.Our efforts in India focus on key issues that will affect the future of India s most vulnerable communities: reproductive, maternal, newborn, and child health and nutrition; urban sanitation; agricultural development; gender equality, and digital financial inclusion.With a particular focus on Bihar and Uttar Pradesh, we work with partners to develop impactful and sustainable solutions to improve the quality and coverage of key services for the poor and vulnerable. We also work in the states of Tamil Nadu, Andhra Pradesh, Odisha, and Maharashtra to support programs in urban sanitation, agricultural development, gender equality, and digital financial inclusion.Team SummaryThe goal of the Vaccine Development & Surveillance Team is to advance public goods for global health through technological innovation. We do this by accelerating the development and commercialization of novel vaccines and the sustainable manufacture of existing vaccines, defining the global disease burden through better primary data and world-class modeling, and reducing the threat of epidemics through the development and use of innovative tools.Position Summary & Core ResponsibilitiesThe Senior Program Officer (SPO) will use their technical and strategic knowledge of vaccines and biologics bio-processing, bio-analytics, and formulation research and development, as well their knowledge of quality systems and formal CMC (Chemistry, Manufacturing and Controls), to develop and implement innovative and sustainable technical solutions for Global Health (GH) related vaccine development projects. The SPO CMC shapes and guides these CMC solutions for foundation program strategy teams and partners. You will be a member of the Vaccine Development and Surveillance (VD&S) CMC Domain and report to the Deputy Director Digital and Health Innovation with a dotted line of reporting to the Deputy Director VD &S CMC.Key responsibilities will include:CMC Strategies and Solutions
• Partner with Deputy Director (DD), Vaccine Development & Surveillance (VDS) CMC, as well as other CMC team members and specialists across fields, to strategically develop and implement technical solutions that speed and de-risk the development of appropriate vaccine candidates for global health needs.
• Shape and manage implementation delivery and impact measurement of Bioprocess R&D and CMC solutions toward approved GH strategy objectives.
• Partner with DD, VD&S CMC to conceptualize, articulate and implement effective and strategic CMC solutions. This will include looking for alignments across multiple vaccine programs and objectives and translating new knowledge into effective interventions and decisions.
• Guide implementation of CMC related grant portfolio aspects, create robust systems that ensure quality grantee interactions, balance in the portfolio, and effective annual planning.
• Negotiate, implement, and manage a portfolio of grants or performance-based contracts; including alignment of internal and external collaborators, review of letters of inquiry and grant proposals as well as providing clear, concise and insightful written analyses and recommendations for funding.
• Provide strategic and technical CMC expertise for internal Program Strategy Teams (PSTs) and partners.
• Synthesize commercial and technical information toward strategic decisions; clearly articulate value propositions from both a business and technology perspective.
• Form key partnerships with individuals, industry organizations and others to enhance implementation of the program s strategy and tactics.
• Provide rigorous reviews of GH programs that incorporate contributions from both internal and external partners and anticipate mid-course corrections, project impact and propose appropriate changes.
• Create and support the VD&S team s goal achievement, create systems to track progress and ensure accountability and link VD&S CMC efforts to GH and foundation missions.
• Contribute to integration of strategies and execution of plans across VD&S and other GH teams.
• Provide consistently superb leadership and exceptional management of CMC related internal and external partners.
Management for Impact
• Guide the CMC efforts in optimizing the level of engagement required for specific team and grantee support.
• Craft grants or contracts such that GH resources are efficiently and expertly used.
• Integrate strategies and implement plans across VxDev, GH and other Foundation teams (e.g. Global Development).
Core Knowledge & Skills
• Commitment to innovation and advancing new technologies in vaccine manufacturing.
• Experience with business and technical due diligence assessments of potential corporate, product or technology investments; ability to synthesize technical and commercial information towards strategic decision making.
• Experience with project management principles and tools to manage complex projects.
• Solid understanding of the realities and complexities of matrix-based organizations.
• Proven ability to lead and influence data-driven planning and implementation.
• Demonstrated experience working in cross-functional teams.
• Administration and fiduciary responsibilities.
• Demonstrated experience in scientific writing and data analysis, written and oral communication skills, and experience. advocating and communicating with a broad and diverse audience.
• Experience in a role requiring collaboration in a complex internal and external organization.
• Demonstrated ability to work with efficiency, diplomacy, and flexibility particular as part of a team effort.
• Sense of humor.
• Commitment to transparency and real-time information sharing.
• Experience leading teams with diverse culture and professional backgrounds.
• An understanding of regulatory requirements necessary for various phases of drug development.
• Previous experience supporting a highly skilled and demanding client base with diverse backgrounds.
• Demonstrated ability to build relationships to gain the respect and trust of others.
• Intellectual quickness, curiosity, discipline, resourcefulness and resilience.
• Ability to work with flexibility, efficiency, enthusiasm, and diplomacy both individually and as part of a team effort.
• Demonstrated passion for the Foundation s values and commitment to deliver results against the Foundation s mission.
Education and Experience
• Ideally, BS/MS or equivalent degree with 10 years of related experience, in the design and implementation of CMC development and/or manufacturing solutions for a broad range of vaccines and biologics. Candidates with PhD would be preferred. Knowledge and experience working with manufacturers in multiple countries is a plus.
• Demonstrated experience in data analysis, written and oral communication skills, and experience advocating and communicating with a broad and diverse audience.
• Ability to synthesize technical and commercial information toward strategic decision making.
Hiring RequirementsAs part of our standard hiring process for new employees, employment will be contingent upon successful completion of a background check.Depending upon your work location, we may require proof of full vaccination against COVID-19 and any recommended booster doses. All employees based in the United States are to provide proof of full vaccination upon hire and any recommended boosters, subject to applicable laws.AccommodationsIf you require assistance due to a disability in the application or recruitment process, please submit a request to hrgatesfoundation.org .Inclusion StatementWe are dedicated to the belief that all lives have equal value. We re committed to creating a workplace where employees thrive both personally and professionally. We also believe our employees should reflect the rich diversity of the global populations we aim to serve in race, gender, age, cultures and beliefs and we support this diversity through all of 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.,

Keyskills :
private sectordata analysischild healthcmc developmentcontinuous improvement facilitationglobal healthquality systems