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Deputy Director, Chemistry and Manufacturing
2 months ago
We are seeking a highly experienced and motivated Deputy Director to join our Integrated Development team at the Bill and Melinda Gates Foundation. The successful candidate 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).
Key Responsibilities- 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.
- 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.
We recognize high-wage market differences where our offices are located, in Seattle, Washington D.C., and Boston (Cambridge). The salary range for this role is $256,800 to $397,700 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.
