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Senior Program Officer, Chemisty Manufacturing and Controls, Integrated Development, Global Health

This job is no longer available

Seattle, WA, USA
Full-time

The Integrated Development CMC domain supports drug development programs across multiple disease and therapeutic areas in Global Health and Global Development.  The programs span the range from development of NCE’s to development of novel dosage forms of approved drugs for high burden diseases in Global Health to meet the needs of populations in low income countries (LIC’s). 

Our team works with a wide range of partners including academic organizations, biotech start-ups, major pharmaceutical companies and nonprofit organizations with varying levels of CMC capabilities to achieve broad impact in Global Health. Technical challenges for Global Health drug development encompass the already substantial challenges inherent in product development for high income settings along with additional requirements such as: stability under extreme climates with limited cold chain; ruggedness to reach remote areas; ease of use by patients and healthcare providers with limited training and facilities; compatibility with the needs and preferences of patients and healthcare providers across varying geographies and cultures.  In addition, drugs for Global Health applications must be of the highest quality as well as cost effective and affordable to LIC’s.

We are seeking an exceptional Senior Program Officer (SPO) to work as a core member of the IDev CMC team to shape and guide the implementation, delivery and impact measurement of CMC solutions toward the foundation’s strategic objectives. The SPO will work directly with internal foundation Program Strategy Teams (PST) and external grantees/partners to provide strategic and technical guidance on CMC-related issues and decisions for a broad range of innovative drug development programs, mainly centered on small molecules therapeutics, possibly incorporating long-acting and other advanced drug delivery technologies to enable adherence to sometimes lengthy treatment or prevention regimens in the most challenging environments. 

Areas of Responsibility: 
  • Provide strategic and tactical support to CMC activities for a PST’s portfolio of drug development investments from strategic framing to implementation and monitoring of results.
  • Utilize comprehensive advanced knowledge of small molecule CMC drug development, along with demonstrated product development, scientific, management, and strategic planning skills, to serve as partner and resource to grantees, development partners and internal PSTs.
  • Enable successful integration and execution of CMC drug development plans across IDev, Global Health, and other foundation teams; identify synergies across matrixed team work streams and translate new knowledge into effective CMC-related interventions and decisions.
  • Develop and manage a portfolio of high-impact CMC related product development grants to help drug development investments reach aggressive cost, quality and therapeutic effectiveness targets. Identify potential technologies and partners for investments including developing strategic objectives and key deliverables; integrated project plans, key milestones and timelines; providing technical guidance through consultation with subject matter experts as required; and monitoring progress against set milestones and timelines.
  • Build and work effectively with a network of subject matter experts in diverse areas of CMC product development to bring the full range of CMC expert advice needed to progress each investment as quickly and effectively as possible.
  • Provide consistently effective leadership and relationship management of CMC related internal and external partnerships and investments.
  • Communicate CMC strategies and decisions to our internal and external partners
  • Play a strategic role in CMC related issues relevant to regulatory interactions and submissions. 
  • Attend internal meetings to represent IDev and CMC issues, as well as being a representative of the foundation at external meetings.
Educational Background: 
PhD in chemistry, pharmaceutical chemistry or a related field.
Skills/Experience: 

We are looking for people who enjoy the challenge of working on complex problems and collaboratively creating solutions that have the potential for transformational change in the lives of people around the world. S/he must be prepared to work across a diverse set of disciplines, bridging a wide range of expertise all the while being a solid team player, with a demonstrated ability to work with flexibility, efficiency, and diplomacy in a fast-paced, challenging environment.

We seek an experienced professional with a demonstrated record of success in developing complex drug delivery products, including, preferably, more than one commercial product.

Additionally, they should have:

  • A minimum of 15 years industry or related experience managing the design and implementation of CMC solutions for a broad range of pharmaceuticals, with an emphasis on small molecule drugs.
  • Experience across all phases of small molecule drug development, with significant late stage development experience.  Experience in product development for emerging markets is a plus. 
  • Working knowledge of a broad range of critical CMC development activities and requirements including API process development and analytical development as well as dosage form development.   Tech transfer, GMP manufacturing and/or Quality experience is an asset
  • Significant experience and accomplishments in CMC product development incorporating one or more long acting or other complex drug delivery technologies. 
  • Working knowledge of regulatory requirements for all phases of drug development is a must, and a history of productive interactions with regulators is a significant asset.
  • Proven ability to synthesize scientific/technical and commercial factors toward strategic decision making as well as lead and influence data-driven strategy planning and implementation.
  • Excellent written and oral communication skills, including proven ability to advocate effectively with diverse audiences with a broad range of perspectives.
  • Proven ability to operate effectively in a role requiring collaboration across complex internal and external organizations, including a solid understanding of the realities and complexities of matrix-based organizations.
  • Ability to work productively in teams with diverse cultural and professional backgrounds.
  • Ability to travel up to 30% domestically and internationally.
  • Ability to work with flexibility, efficiency, enthusiasm, and diplomacy both individually and as part of a team effort.
  • A sense of humor.
  • Demonstrated passion for the foundation’s values with commitment to deliver results against the foundation’s mission.

Organization Info

Bill and Melinda Gates Foundation

Overview
Headquarters: 
Seattle, WA, United States
Annual Budget : 
More than $500M
Founded: 
2007
About Us
Mission: 

Guided by the belief that every life has equal value, the Bill & Melinda Gates Foundation works to help all people lead healthy, productive lives. In developing countries, it focuses on improving people’s health and giving them the chance to lift themselves out of hunger and extreme poverty. In the United States, it seeks to ensure that all people—especially those with the fewest resources—have access to the opportunities they need to succeed in school and life. Based in Seattle, Washington, the foundation is led by CEO Dr. Susan Desmond-Hellmann and Co-chair William H. Gates Sr., under the direction of Bill and Melinda Gates and Warren Buffett.

We work with partner organizations worldwide to tackle critical problems in four program areas. Our Global Development Division works to help the world’s poorest people lift themselves out of hunger and poverty. Our Global Health Division aims to harness advances in science and technology to save lives in developing countries. Our United States Division works to improve U.S. high school and postsecondary education and support vulnerable children and families in Washington State. And our Global Policy & Advocacy Division seeks to build strategic relationships and promote policies that will help advance our work. Our approach to grantmaking in all four areas emphasizes collaboration, innovation, risk-taking, and, most importantly, results.

Programs: 
  1. Global Health
  2. Global Development
  3. United States
  4. Global Policy & Advocacy

Listing Stats

Post Date: 
Jul 7 2019
Active Until: 
Aug 7 2019
Hiring Organization: 
Bill and Melinda Gates Foundation
industry: 
Nonprofit