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 M4ALLs 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.

Required Knowledge Skills and Abilities

• Education: Chemical Engineering Chemistry or a related field; or the experience and skills that equate to a Ph.D.

• Experience: Minimum of 10 years of experience in pharmaceutical manufacturing (drug substance / active pharmaceutical ingredients) with a focus on early phase process R&D including at least 5 years in a leadership role

• Leadership Abilities: Proven experience in leading innovation and managing teams with a demonstrated ability to develop talent and foster a culture of teamwork and continuous improvement.

• Cultural Competency: Proven experience fostering and contributing to a diverse environment for faculty staff and students or a strong commitment to doing so at VCU.

• Troubleshooting and Independent Judgment: Robust set of decision-making and judgement responding calmly and effectively in crisis situations with excellent problem-solving and troubleshooting skills

• Travel: Willingness to travel domestically and internationally (anticipated up to 10% of time)

• Risk Management: Expertise in identifying assessing and mitigating project risks with the ability to implement corrective actions to keep projects on track.

• Communication and Collaboration: Effective verbal written and listening skills including the ability to interact effectively across the organization in situations that may require instruction persuasion negotiation and resolution of conflict

• Results-Oriented: Proven ability to drive projects to successful completion within scope on time and within budget especially under resource-constrained and high-stakes environments.

• Strategic Thinking: Ability to contextualize long term strategies and short-term requirements

• Unwavering commitment to aligning and adhering to M4ALLs core values and purpose.

• Demonstrated experience working in and fostering an environment of respect professionalism and civility with a population of faculty staff and students from various backgrounds and experiences or a commitment to do so as a staff member at VCU.

Reporting Structure

This role reports to the Head of R&D and is intended to be a key supervisory position within the team. Additionally this role embodies everyday leadership with an expectation to lead through actions discussions decisions and interactions. As a role model within the organization you will influence others by consistently demonstrating the values and behaviors that drive our mission forward.

Work Environment and Location
This position is open to fully remote employees with the flexibility to work from home. However candidates must be able to travel to our primary worksite in Richmond Virginia as needed for meetings events or other key responsibilities.

Since M4ALLs inception in 2017 we have received significant financial support from a diverse portfolio of major donors. This position is grant-funded with continued employment contingent upon ongoing funding.

Benefits of Working at VCU include:

The university and the region

VCU is a public research university unlike any other dedicated to serving the needs of students and patients. Inclusion is our heartbeat and it drives us to tackle difficult challenges others cant or wont. Were home to creativity teaching discovery and healing. Our location in the heart of downtown Richmond Virginia means the nonstop energy of our city ignites our innovation and provides unlimited opportunities for our students.

About Virginia Commonwealth University

We are the university for Virginia. We know that the unique backgrounds and life experiences of the VCU community are what drive the university forward. Together were forging a future that is built by us. Here artists and engineers doctors and designers come together to reimagine the human experience and tackle the problems of tomorrow.

VCU dates to 1838 with the formation of the Medical Department of Hampden-Sydney College whose mission was to educate physicians in central Virginia and which was later renamed Medical College of Virginia. In 1968 Richmond Professional Institute merged with the Medical College of Virginia to become what is now known as Virginia Commonwealth University.

Located in downtown Richmond the state capital of Virginia VCU enrolls more than 28000 students in more than 200 degree and certificate programs across its urban campuses: the downtown Monroe Park and MCV campuses in Richmond; the Rice Rivers Center in Charles City Virginia; satellite locations in Fairfax Virginia and Abingdon Virginia; and a campus in Doha Qatar for the School of the Arts.

Ignited by the energy of the city were ready to lead industries or disrupt them. We seek out the unexpected the experimental the never-been-tried. VCU is designated as a research university with very high research activity by the Carnegie Foundation garnering more than $500 million in sponsored research from federal and other agencies in FY2024. The National Science Foundation ranked VCU among the top 50 public research universities in the country and we are one of only 69 public universities nationwide to be designated by the Carnegie Foundation as Community Engaged with Very High Research Activity.

This research enterprise and the influence of having one of the nations top-ranked public graduate arts schools ensures students receive unique educational experiences that equip them with a creative mindset that sets them apart.

VCUs contributions in talent innovation and entrepreneurialism regional stewardship and local culture shape the economic impact and overall quality of life in the region. VCU as a whole generates more than $9 billion in economic activity. It is the largest employer in Richmond with more than 26000 employees at VCU and VCU Health and it supports approximately 58000 jobs in Virginia. In addition Virginia classifies VCU with a Tier III status the highest possible status for universities and colleges allowing VCU more flexibility in managing its operations to implement best practices and streamline processes. To learn about VCUs finances visit.

VCUs unwavering commitment to diversity inclusion equity and student success is why INSIGHT into Diversity magazine has named us a Diversity Champion six times in a row as part of its annual Higher Education Excellence in Diversity Awards. And many students say that the best thing about VCU is its diversity.

VCUs mission under the leadership of President Michael Rao Ph.D. is to serve as one national urban public research institution dedicated to the success and well-being of our students patients faculty staff and community through:

• Real-world learning that furthers civic engagement inquiry discovery and innovation.

• Research that expands the boundaries of new knowledge and creative expression and promotes translational applications to improve the quality of human life.

• Interdisciplinary collaborations and community partnerships that advance innovation enhance cultural and economic vitality and solve societys most complex challenges.

• Health sciences that preserve and restore health for all people seek the cause and cure of diseases through groundbreaking research and educate those who serve humanity.

• Deeply ingrained core values of diversity inclusion and equity that provide a safe trusting and supportive environment to explore create learn and serve.

Welcome to VCU. A world unlike any other.

About Richmond Virginia

As the commonwealths capital Richmond Virginia offers a vibrant mix of history diverse culture and real-world opportunities. Distinct neighborhoods cozy restaurants and cafes and quaint local markets give the city an intimate feel but theaters galleries music festivals sports attractions and a steady stream of annual events bring RVA as locals call the region to life. Established in 1780 its rich history can be seen in the architecture the Capitol grounds and the cobblestone streets around the city. With the historic James River and 600 acres of parks bordering it bike trails wineries breweries a flourishing arts entertainment and restaurant scene (Food and Wine called Richmond a culinary powerhouse) and affordable suburbs this small city punches well above its weight in terms of attractions and buzz. In fact Travel Leisure named Richmond the best place to live in Virginia in 2023 and Southern Living named Richmond one of the 20 best cities to live in the South in 2024.

Richmonds location in the middle of the state allows for day or weekend trips to the beach the Blue Ridge Mountains or Virginias many wineries. Its within a two-hour drive of Washington D.C. and a multitude of excellent institutions of higher education. The Richmond metropolitan area is also home to several Fortune 500 companies a broad base of financial companies hospitals and media firms high-tech manufacturing companies and state and local government agencies. Entrepreneurs and artists put down roots in Richmond and Thrillist named it one of the best U.S. cities for creatives in 2022.

Beyond Richmond CNBC has named Virginia as the No. 1 state in the country to do business six times since the study began in 2007. It has accomplished this by bringing in billions in capital investment and thousands of new jobs; investing in education; expanding access to quality health care for all; making sure everyone has access to opportunity; and more. Business Facilities magazine named Virginia the 2024 State of the Year. Suffice to say Virginia is full of growth and opportunity making it the perfect location for a university determined to erase barriers and provide students with robust learning experiences that will make them unstoppable.

Required Experience:

Director