Senior Scientist, Process Development

Job Summary

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 active pharmaceutical ingredient (API) 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.

We are seeking a mission-driven professional to join our team in tackling critical global health challenges in the position of Senior Scientist Process Development. This role encompasses a diverse range of responsibilities including small molecule process research and development project leadership and delivery (e.g. contract service projects internal platform innovation projects) and partner relationship management. Our new colleague will be responsible for building the scientific excellence of the Institute by delivering superior research results in the field of synthetic organic chemistry. Your efforts will be directed toward the design and development of multistep synthetic routes to approved and investigational active pharmaceutical ingredients with an emphasis on process research (route scouting) development (optimization demonstrative scale-up) and technology transfer.

API Process Development - Project Leadership

• Lead project teams in the development of 1st generation (clinical) and 2nd generation (commercial) API manufacturing processes as needed. Deliver process development innovation excellence - ensuring scalability efficiency cost-effectiveness and safety. Act as the primary technical liaison for clients and partners fostering strong relationships and delivering high-impact outcomes.

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

• Apply deep process chemistry expertise across route scouting optimization scale-up and tech transfer as part of the API lifecycle.

• Collaborate seamlessly with Analytical MSAT EHS Commercial and Project Management teams to meet project milestones on time and within budget.

API Process Development Individual Contribution

• Lead conduct and thoroughly document literature reviews for target chemical transformations and APIs. Identify and classify reported strategies. Articulate process improvement opportunities reflecting expert understanding of manufacturing norms.

• Design and evaluate synthetic routes to target APIs and intermediates with a focus on cost sustainability minimization of chemical steps / unit operations and safety.

• Develop and execute hypothesis-driven experiments. Translate results into new experiments that will lead to lower costs and/or process improvements.

  • In process research (route scouting) assess many valid reaction conditions and identify trends for improved outcomes.

  • In process development (optimization) perform careful data-rich experiments that create robust knowledge of the chemical system and transformation.

• Leverage high-throughput experimentation equipment and software (including automation DOE) to accelerate development and build M4ALL reaction databases

• Deliver results in a high-pace and time-sensitive environment.

• Demonstrate robust data interpretation. Incorporate data-driven insights into reports and designs for chemical process improvement.

• Maintain a detailed accurate and up-to-date electronic lab notebook (ELN) to ensure robust knowledge management

Project Management

• Demonstrate timely and proficient use of M4ALLs project management tools to support internal coordination and client communication

• Demonstrate project budget awareness and good stewardship in the purchase and use of consumables reagents solvents key starting materials and intermediates.

• Track timelines and deliverables escalating risks proactively to maintain transparency.

Strategy Development & Execution

• Support the development of new technology platforms that accelerate drug substance development and differentiate M4ALLs technical offerings. (Advanced Chemistry Technology)

• Continuously evaluate and improve work processes to drive M4ALLs operational excellence with the aim of constantly improving customer / collaborator experience.

Interdepartmental and External Communications

• Prepare clear accurate and concise written project updates and reports (pptx docx) representing your contributions. Contribute well-written high-quality scientific content for publication e.g. peer-reviewed articles trade journal articles white papers M4ALL social media. (Technical Writing)

• Communicate research findings effectively through written and oral formats including publications and stakeholder updates.

• Address project or interpersonal misalignments constructively seeking clarity and resolution when needed.

• Support documentation efforts across SOPs work instructions hazard assessments and technical publications.

Team & Infrastructure Development

• Support onboarding new Scientists Technicians and Postdocs as member of buddy network to ease their transition into the M4ALL team

• Develop proficiency in M4ALL tech (IT) and infrastructure for critical unit operations and contribute to its effective use and evolution

Championing VCUs and M4ALLs Core Values:

• Embody M4ALL and VCUs values: Mission-first focus Integrity Safety Respect Customer-centricity Adaptability Transparent Communication and Collaboration

Required Education & Technical Abilities

• Education: PhD in Organic Chemistry (total synthesis of natural products novel synthetic methods development) Organometallic Chemistry or Chemical Engineering. Individuals with significant years experience and training equivalent to a PhD will be considered.

• Experience: Minimum of 5 years experience in pharmaceutical manufacturing (drug substance / active pharmaceutical ingredients) with a focus on early phase process R&D. Current working knowledge and ongoing application of best practices in industrial process chemistry process development/chemical development and scale-up.

Advanced Chemistry Technologies: Experience with one or more of the following enabling technologies: continuous / continuous flow chemistry high throughput experimentation applied automation of process R&D workflows applied artificial intelligence / machine learning in process R&D applied biocatalysis sustainable methods development (e.g. micellar catalysis)

Project Leadership Abilities: Proven experience leading project teams in multi-organization innovation programs - collaborative and third party-sponsored (i.e. contract service projects).

Technology Transfer: Experience working with manufacturers to transfer processes from process research and development to pilot and manufacturing scales (clinical and/or commercial)

Required Interpersonal Skills & Individual Aptitude

• Communication and Collaboration: Demonstrate highly effective verbal and written communication skills including the ability to interact effectively within and outside of the organization in situations that may require instruction persuasion negotiation or conflict resolution. Demonstrate comfort and confidence delivering technical and/or technical marketing presentations that are clear concise and accessible to audiences of varied composition (technical and non-technical).

• 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

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

• Accountability and collaborative mindset to achieve organizational success for high quality timely and cost-effective results within specified deadlines.

• Innovative and creative problem solving to develop solutions/alternatives understanding of the feasibility and the value in taking responsible risks.

• Scientific Entrepreneurship: Energy and passion to thrive in a start-up environment and to deliver on the organizations goals mission and values balancing the interests of ones own with those of the broader organization.

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

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

Preferred Knowledge Skills and Abilities

• Experience with the application of Design of Experiments kinetic and thermodynamic analyses (e.g. RC1) mechanistic investigations.

Please note applicants must be authorized to work in the United States without the need for current or future visa or permanent residence sponsorship. Sponsorship is not available for this position.

Reporting Structure

This role reports to (Associate) Director Process Development and 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

100% onsite at the VA BioTech Park

Since M4ALLs inception in 2017 we have received significant financial support from a 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 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 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.

Welcome to VCU. A world unlike any other.

About Richmond Virginia

As the commonwealths capital Richmond Virginia offers a vibrant mix of history 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 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:

Senior IC