Senior Scientist, Process Development - Medicines for All Institute

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.

Primary Responsibilities:

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 M4ALL's 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 M4ALL's technical offerings. (Advanced Chemistry Technology).
• Continuously evaluate and improve work processes to drive M4ALL’s 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 VCU’s and M4ALL’s Core Values

• Embody M4ALL and VCU’s values: Mission-first focus, Integrity, Safety, Respect, Customer-centricity, Adaptability, Transparent Communication, and Collaboration

Qualifications:

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.
• Cultural competency: Demonstrated ability to work in and foster an environment of respect, professionalism and civility with a population of faculty, staff, and students from all backgrounds and experiences, or a commitment to do so as a staff member at VCU.
• Scientific Entrepreneurship: Energy and passion to thrive in a start-up environment and to deliver on the organization’s goals, mission and values balancing the interests of one's 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 Qualifications

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

Additional Details:

Salary Range: Starting at $110,600, Commensurate with experience

Benefits: All full-time university staff are eligible for VCU’s robust benefits package that includes comprehensive health benefits, paid annual and holiday leave granted up front, generous tuition benefits, retirement planning and savings options, tax-deferred annuity and cash match programs, employee discounts, well-being resources, abundant opportunities for career development and advancement, and more.

FLSA Exemption Status: Exempt

Hours per Week: Minimum of 40 hours/week; Monday - Friday (day shift)

Restricted Position: Yes, continued employment is contingent upon funding

ORP Eligible: Yes

Flexible Work Arrangement: On-site Requirement

Eligible for sponsorship (e.g. H-IB visa status, etc.): No

Contact Information: M4all@vcu.edu