PATH is an international organization that drives transformative innovation to save lives and improve health, especially among women and children. We accelerate innovation across five platforms-vaccines, drugs, diagnostics, devices, and system and service innovations-that harness our entrepreneurial insight, scientific and public health expertise, and passion for health equity. By mobilizing partners around the world, we take innovation to scale, working alongside countries primarily in Africa and Asia to tackle their greatest health needs. Together, we deliver measurable results that disrupt the cycle of poor health.
PATH’s Drug Development Global Program grew from our affiliation in late 2011 with the nonprofit drug development group OneWorld Health. We’re working to discover, develop, and deliver safe, effective, and affordable new treatments for diseases disproportionately affecting people in the developing world. By combining entrepreneurial energy, pharmaceutical expertise, and an innovative product development partnership model, we challenge the assumption that pharmaceutical research and development is too expensive to create the new medicines that the developing world desperately needs.
The Senior Scientist, CMC, Medicinal Chemistry, Drug Development Group is responsible for providing hands-on supervision of CMC activities for projects at PATH's Drug Development Group (DRG) and reports to the Director of Research and Preclinical Development. S/He will be the point person for all chemistry-related activities in several projects. S/he will direct CMC activities through contract research and manufacturing organizations to ensure the timely production and quality control of API and finished drug product for clinical studies. S/he will also support ongoing medicinal chemistry projects conducted in collaboration with academic and industry partners. S/he will lead outsourcing processes, and in collaboration with the project manager, manage relationships with contractors. The Senior Scientist will write and edit CMC sections for grant proposals and regulatory filings. S/he will provide scientific and strategic input to project teams and serve as a key member of internal teams evaluating potential new R&D opportunities, and identifying collaborators and funding opportunities.
Responsibilities and duties include:
Act as point person for all chemistry-related activities in the Drug Development Program
Manage CROs and CMOs to produce compounds for testing, and to supply material for development activities including GMP clinical supplies.
Advise chemical lead-optimization efforts.
Manage drug product development and production through outsourcing.
Provide scientific and strategic inputs to project teams on product development strategy.
Participate in portfolio team to evaluate new R&D opportunities.
Prepare, review and edit medicinal chemistry and CMC sections in grant proposals and regulatory filings.
Develop collaborative relationships with key experts and investigators.
Interact with funders and outside partners on CMC issues relevant to current and future programs.
Must hold a Ph.D. in chemistry, pharmaceutical sciences, chemical engineering or related discipline.
A minimum of 7 years of industry experience.
Broad experience in drug development.
Demonstrated expertise in process development and scale-up for GMP API production.
Expertise in medicinal chemistry for lead optimization.
Experience in working with Chinese CROs/CMOs and/or fluency in Mandarin Chinese.
Familiarity with pharmaceutical dosage forms, formulation and drug product regulations.
Demonstrated familiarity with ICH/cGMP guidelines and regulatory compliance.
Proven ability to foster a collaborative team environment.
Excellent interpersonal skills with ability to mentor and support colleagues both in headquarters and in developing countries.
Excellent written and oral communications skills.
Willingness to travel up to 15%.
Must have legal authorization to work in the United States.
PATH is dedicated to building an inclusive workforce where diversity is valued.
PATH is an equal opportunity employer. Every qualified applicant will be considered for employment. PATH does not discriminate based on race, color, religion, gender, gender identity or orientation, genetic information, age, national origin, marital status, disability status, political ideology, military or protected veteran status, or any other characteristic protected by applicable federal, state, or local law.