Lead Specialist, Chemistry and Production Oversight

2 weeks ago


Seattle, Washington, United States Disability Solutions Full time
About Us

Disability Solutions is a leading nonprofit organization dedicated to addressing poverty, health disparities, and inequity on a global scale. We operate under the belief that every individual, regardless of their background or circumstances, deserves the opportunity to lead a healthy and fulfilling life. Our workforce reflects the diverse communities we serve, and we offer a comprehensive benefits package that includes extensive medical, dental, and vision coverage at no cost, generous paid time off, family leave, retirement contributions funded by the organization, regional holidays, and opportunities for involvement in various employee communities. We are committed to fostering an environment where you can thrive both personally and professionally.

Our Division
Our Global Health division leverages advancements in science and technology to save lives in underprivileged regions. We focus on significant health challenges that disproportionately affect developing countries, often overlooked in terms of funding and attention. Where effective tools are available, we strive to enhance their delivery sustainably. In cases where solutions are lacking, we invest in the research and development of innovative interventions, including vaccines, medications, and diagnostic tools. Our initiatives in infectious diseases target strategies to combat and prevent HIV/AIDS, malaria, tuberculosis, neglected tropical diseases, and other critical health issues.

The Integrated Development (IDev) team plays a crucial role in supporting all facets of product development for our priority health challenges, encompassing regulatory affairs, quantitative sciences, chemistry manufacturing & controls, and clinical trial design.

Your Role

Disability Solutions is seeking a Deputy Director of Chemistry, Manufacturing and Controls (CMC) to join our Integrated Development (IDev) team. The CMC Deputy Director will oversee a team of specialists, providing both technical and strategic guidance to all projects funded by Disability Solutions aimed at developing innovative therapeutic solutions and enhancing access to established treatments for diseases that primarily impact underserved populations in Low-Income Countries (LICs). The portfolio includes over 100 initiatives at various stages of development across multiple therapeutic areas, such as malaria, tuberculosis, neglected tropical diseases, HIV prevention, family planning, and nutrition.

This position presents a unique opportunity for a seasoned and driven CMC leader to leverage their expertise to tackle pressing unmet needs affecting the most vulnerable populations globally. The Deputy Director will engage with a broad spectrum of cutting-edge CMC challenges, collaborating with top-tier scientists and engineers from academia, industry, and nonprofit sectors. This role also provides the chance to mentor a talented team of CMC professionals and significantly influence the future of CMC development in global health.

Key Responsibilities
  • Lead and manage a team of experienced CMC professionals responsible for delivering CMC support to all programs funded by Disability Solutions focused on developing therapeutic interventions for diseases affecting underserved populations.
  • Utilize extensive knowledge and proven expertise in CMC product development to guide internal teams and collaborate with external partners globally on the strategic execution of development plans for therapeutic interventions addressing Global Health needs.
  • In partnership with the CMC team, IDev leadership, and foundation teams, manage a portfolio of impactful innovative CMC technology investments to expedite product development and ensure therapeutic candidates meet ambitious cost, quality, scalability, and deliverability targets.
  • Play a strategic role in navigating CMC-related regulatory interactions and submissions.
  • Provide effective leadership for CMC-related partnerships and investments, fostering and maintaining relationships with key stakeholders.
  • Communicate CMC strategies and decisions effectively to internal and external partners.
  • Participate in internal and external meetings to address CMC issues and drive progress; represent the organization at external engagements.


Qualifications
  • PhD in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related field.
  • A minimum of 15 years of experience in CMC product development within the pharmaceutical, biotech, or related sectors, with a proven track record of contributions to multiple FDA-approved products.
  • A comprehensive understanding of issues related to API and drug substance; formulation and drug product; analytical methods; Quality Systems; GMP manufacturing; and regulatory submission and approval processes.
  • Experience in developing oral small molecule therapeutics is essential; familiarity with sterile products, proteins and peptides, monoclonal antibodies, live biotherapeutics, probiotics, and/or nutritional supplements is a significant advantage.
  • Prior experience in developing therapeutics for infectious diseases and women's health issues primarily affecting patients in low and low-middle income countries is beneficial.
  • Expertise in innovative technology solutions such as long-acting drug delivery systems, cost-effective manufacturing, enhanced formulations for improved bioavailability, and/or drug delivery devices is a plus.
  • Demonstrated ability to collaborate effectively with a diverse range of critical partners, both within and outside the organization.
  • An energetic and inspiring leadership style.


Compensation
The salary range for this role is competitive and reflects the high-wage market differences where our offices are located. As a mission-driven organization, we strive to balance competitive compensation with our mission, and new hires are typically brought into the organization at a salary that aligns with their skills, experience, and expertise as evaluated during the interview process.

Inclusion Statement
We are committed to the principle that all lives have equal value. We aim for a workplace that promotes greater diversity, equity, and inclusion—embracing a variety of voices, ideas, and approaches—and we uphold this commitment through all our employment practices.

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