Deputy Director, Chemistry, Manufacturing and Controls
2 months ago
We are the largest nonprofit fighting poverty, disease, and inequity around the world. Founded on a simple premise: people everywhere, regardless of identity or circumstances, should have the chance to live healthy, productive lives. We believe our employees should reflect the rich diversity of the global populations we aim to serve. We provide an exceptional benefits package to employees and their families which include comprehensive medical, dental, and vision coverage with no premiums, generous paid time off, paid family leave, foundation-paid retirement contribution, regional holidays, and opportunities to engage in several employee communities. As a workplace, we're committed to creating an environment for you to thrive both personally and professionally.
The Team
Our Global Health (GH) division harnesses advances in science and technology to save lives in poor countries. We focus on the health problems that have a major impact in developing countries but get too little attention and funding. Where tools exist, we support sustainable ways to improve their delivery. Where they don't, we invest in research and development of new interventions, such as vaccines, drugs, and diagnostics. Our work in infectious diseases focuses on strategies to fight and prevent HIV/AIDS, malaria, tuberculosis, neglected tropical diseases, enteric and diarrheal diseases, pneumonia, and maternal, newborn and child health.
The Integrated Development (IDev) team is a functional team that supports all aspects of product development for our priority diseases, in the domains of regulatory affairs, quantitative sciences, chemistry manufacturing & controls, and clinical trial design.
*Please note that this search is being run in partnership with SRI Executive Search & Consulting*
Your Role
The Bill and Melinda Gates Foundation is seeking a Deputy Director of Chemistry, Manufacturing and Controls (CMC) to join our Integrated Development (IDev) team. The CMC Deputy Director will lead a team of experts in providing technical and strategic support to all Gates Foundation funded projects to develop novel therapeutic interventions and expand access to proven treatments for diseases affecting primarily poor and neglected populations in Low Income Countries (LICs). The portfolio comprises over 100 programs at all stages of development in a variety of therapeutic areas including malaria, tuberculosis, neglected tropical diseases, HIV prevention, family planning, nutrition, and others.
This is a unique opportunity for a highly experienced and motivated CMC leader to use their expertise and experience to address critical unmet needs affecting the poorest and most vulnerable populations around the world. The Deputy Director will have the opportunity to work on a wide range of cutting-edge CMC challenges, collaborating with world-class scientists and engineers from academia, industry, and non-profit organizations. The role also offers the chance to lead and mentor a team of talented CMC professionals, and to play a key role in shaping the future of CMC development for global health. If you are a highly experienced and motivated CMC leader with a passion for global health, we encourage you to apply for this exciting opportunity.
This position reports to the Director, Integrated Development
What You'll Do
- Lead and manage a team of highly experienced CMC experts with responsibility for providing CMC support to all Gates Foundation funded programs to develop therapeutic interventions for diseases affecting primarily poor and neglected populations in Low Income Countries.
- Apply comprehensive knowledge and demonstrated expertise in CMC product development to advise internal teams and work with external partners around the world on strategy and execution of development plans for therapeutic interventions to meet Global Health needs.
- Working with CMC team, IDev leadership and foundation teams, manage a portfolio of high-impact innovative CMC technology investments to accelerate product development and help therapeutic candidates reach bold cost, quality, scalability and deliverability targets.
- Play a strategic role in addressing CMC-related issues pertaining to regulatory interactions and submissions.
- Provide effective leadership of CMC related internal and external partnerships and investments including building and maintaining relationships with key stakeholders.
- Communicate CMC strategies and decisions to our internal and external partners.
- Attend internal and external meetings to address CMC issues and drive progress; represent the foundation at external meetings.
Your Experience
- PhD in Chemistry, Biochemistry, Pharmaceutical Sciences or a related discipline
- Minimum of 15 years' experience in CMC product development in the pharmaceutical, biotech or related industry with demonstrated success reflected by a history of contributions to multiple FDA-approved products.
- Broad understanding of issues related to API and drug substance; formulation and drug product; analytical methods; Quality Systems; GMP manufacturing; and regulatory submission and approval requirements.
- Experience in developing oral small molecule therapeutics is a requirement; experience with development of sterile products, proteins and peptides, monoclonal antibodies, live biotherapeutics (microbiome), probiotics and/or nutritional supplements are significant assets.
- Prior experience in development of therapeutics for infectious diseases and women's health conditions that primarily affect patients in low and low-middle income countries is a plus.
- Expertise with innovative technology solutions such as long-acting drug delivery technologies, low-cost manufacturing, improved formulations to enhance bioavailability and/or reduce manufacturing costs, and/or drug delivery devices is an added advantage.
- Demonstrated ability to work collaboratively with a wide variety of critical partners, both internal and external to the Foundation
- Energetic and energizing leadership style
The salary range for this role is $256,800 to $397,700 USD. We recognize high-wage market differences where our offices are located, in Seattle, Washington D.C., and Boston (Cambridge). The range for this role in these locations is $279,600 to $433,300 USD. As a mission-driven organization, we strive to balance competitive pay with our mission and new hires are typically brought into the organization at a salary between the range minimum and the salary range midpoint. Actual placement in the range will depend on a candidate's job-related skills, experience, and expertise, as evaluated during the interview process.
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Hiring Requirements
As part of our standard hiring process for new employees, employment will be contingent upon successful completion of a background check.
Candidate Accommodations
If you require assistance due to a disability in the application or recruitment process, please submit a request here.
Inclusion Statement
We are dedicated to the belief that all lives have equal value. We strive for a global and cultural workplace that supports ever greater diversity, equity, and inclusion - of voices, ideas, and approaches - and we support this diversity through all 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.
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