Associate Director, Process Development

Medicines for All (M4ALL), a part of Virginia Commonwealth University, is an entrepreneurial, impact-oriented institute dedicated to dramatically improving global access to lifesaving medicines. We achieve this through synthetic process innovation and advanced technology deployment to reduce costs and waste in small molecule drug substance (active pharmaceutical ingredient) production. Our API process development services support treatments for diseases such as TB, malaria, HIV, oncology, metabolic diseases, CNS, and immunology. We work in service to – and partnership with – non-profit organizations and translational research-focused companies and institutes.

Job Summary 

We are seeking an Associate Director, Process Development to lead high-impact programs for M4ALL clients and partners, focusing on process development, route scouting, optimization, scale-up, and technology transfer. This role will drive strategic Process Development initiatives, manage multiple projects, and collaborate with internal teams and external partners to enhance efficiency and innovation. The Associate Director will mentor scientists, ensure rigorous documentation, and contribute to publications while maintaining a strong focus on safety, compliance, and continuous improvement.

Key Responsibilities

API Process Development Project Leadership

• Direct and manage multiple development service projects, prioritizing resources to meet key milestones and deadlines in a fast-paced environment.

• Act as the principal technical liaison for clients’ technical and project management stakeholders, pursuing customer success and satisfaction.

• Deliver timely, high-quality customer engagements through diligent project management and regular, solutions-driven communications (oral and written). Adhere to mutually established priorities and delivery timelines, prioritizing transparency, accountability, and a service mindset.

• Leverage extensive process chemistry expertise to deliver high-impact services spanning process research (route scouting), development (optimization), scale-up, and technology transfer.

• Partner with cross-functional teams, including Analytical Development, MSAT/Manufacturing, EHS, and Project Management to realize seamless collaboration and project advancement against milestones.

• Maintain a deep technical literacy. Ensure data-driven decision-making and process improvements based on rigorous experimentation.

• Oversee early-stage and product life cycle development-stage API process development, ensuring scalability, efficiency, and cost-effectiveness.

• Identify and implement cutting-edge methodologies and technologies to enhance process efficiency and innovation.

• Author technical sections of customer proposals, working in partnership with Commercial, Finance, and Project Management colleagues to create winning responses to client requests for proposals. Serve as a liaison between Development and business operations, ensuring that technical strategies align with financial and programmatic objectives.

• Guide teams in conducting literature reviews, assessing viability of synthetic routes, and executing new chemical reactions at scale.

API Process Development Team Leadership & Development

• Ensure observance of best practices for project governance, reporting, and performance tracking (KPIs) within API Process Development.

• Ensure observance of best-practice workflows in process research (route scouting), development (optimization), and technology transfer to efficiently cultivate requisite process knowledge and deliverables at each step

• Build and lead (a) high-performing project team(s), setting the foundation for growth and fostering a collaborative, mission-driven culture.

• Create meaningful opportunities for talent development and career growth. Leverage and continuously improve supporting organizational processes (e.g., organizational talent reviews, performance management, regular 1:1s)…

• Provide mentorship, set goals, and establish performance expectations for Process Development staff, cultivating a focus on accuracy, accountability, and professional growth.

• Implement training and professional development programs to enhance team capabilities across pivotal unit operations in API chemical process development (reaction, workup, isolation, purification, micronization, etc.).

• Grow M4ALL capabilities (expertise, infrastructure) in market-driven technology and innovation domains (e.g., cheminformatics and applied AI, continuous-flow manufacturing, biocatalysis, automation/robotics, green chemistry, etc.)

• In partnership with executive leadership, develop and execute multi-generational plans for Process Development, reducing long-term capability and performance objectives into a year-over-year programmatic action.

Platform Innovation Strategy and Leadership

• In partnership with executive leadership, develop and execute the platform innovation strategy for Process Development, ensuring alignment with M4ALL’s mission and long-term objectives.

• Drive the development and deployment of market-driven novel methodologies and technologies – i.e., new service offerings - to improve the cost-effectiveness and sustainability of API manufacturing

• Foster collaboration with internal and external stakeholders to identify emerging trends, service opportunities, and strategic partnerships.

• Represent M4ALL in discussions with external partners, industry stakeholders, and funding agencies to strengthen collaborations and advance innovative process development.

• Lead efforts to standardize documentation, knowledge-sharing, and data-driven decision-making within the PD team (e.g., digitalization, knowledge management systems deployment complementing ELN)

Continuous Improvement

• Measure the impact of continuous improvement initiatives through the KPI lens (see Team Leadership above), providing insights and reports to executive leadership and stakeholders.

• Ensure thorough project documentation, data analysis, and reporting to internal and external stakeholders.

• Establish robust workflows for evaluating raw material costs and optimizing reaction conditions to drive cost reduction.

• Implement and advocate for continuous improvement within R&D operations, assessing project effectiveness and refining strategies as needed.