Associate Director/Director*, Manufacturing Science And Technology (Msat) - Medicines For All

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 drug substance manufacturing. Our work supports treatments for diseases such as COVID-19, HIV, TB, and malaria.

We are seeking a Manufacturing Science and Technology leader with a strong blend of technical expertise, leadership abilities, and strategic vision to help us drive technological advancements and make affordable medications accessible worldwide! Applicants who meet the required qualifications and have varying levels of experience are encouraged to apply. The role will be filled at either the Associate Director or Director level, depending on the unique qualifications and experience of the selected candidate.*

Key Responsibilities:

The Associate Director/Director* of Manufacturing Science and Technology (MSAT) is a key leadership position at M4ALL, responsible for overseeing the implementation of robust and efficient manufacturing processes and the continuous advancement of M4ALL's manufacturing assets and capabilities. Our new colleague will bring a strong technical background in small molecule drug substance manufacturing, a passion for building and leading high-functioning manufacturing teams, and excellent problem-solving skills. They will foster a culture of safe operations, stringent regulatory compliance, and continuous improvement. The successful candidate will bring a highly collaborative mindset, stewarding cost-advantaged processes into Manufacturing in partnership with leaders across M4ALL departments.

Technology Transfer:

• Lead efforts to develop, optimize, and scale up manufacturing processes for drug substances and drug products

• Design laboratory experiments to support process design, optimization, and technology transfer objectives. Develop process data based on a fundamental understanding of the underlying physical processes.

• Ensure thorough characterization of intermediate and API processes and products. Deliver effective documentation of the process description, in-process assays / measures, acceptable ranges, and specifications (and the justification of the latter three deliverables).

• Define scientifically robust, defensible control strategies for API manufacturing and reduce them to practice via unit operation requirements. (Strive for right-first-time technology transfer.)

• Manage the transfer of manufacturing processes from development to clinical and commercial production - internally, and to third-party manufacturing operations (CDMOs, CMOs, etc.)

• Collaborate with process chemists and engineers to develop, and advance robust manufacturing processes - internally, and at third-party manufacturers

• Identify and implement advanced technologies and innovative approaches to improve manufacturing processes and capabilities (e.g., PAT, in silico modeling). Stay current with industry trends and advancements in pharmaceutical manufacturing.

Manufacturing Excellence:

• Anticipate commercial manufacturing challenges. Implement appropriate product control strategies based on anticipated needs.

• Provide technical leadership for technology transfers between Development and manufacturing sites (internal or external)

• Implement continuous improvement initiatives to enhance process efficiency, reduce costs, and improve product quality

• Integrate cross-functional and/or external information and apply technical knowledge to deliver data-driven decision-making

Manufacturing Capability Development:

• Lead the design, construction, and commissioning of M4ALL's first early clinical-scale manufacturing facility in Chesterfield County, Virginia (pilot plant)

• Build, lead, and mentor a team of MSAT professionals - process engineers, process chemists, operators - fostering a culture of collaboration, aligned to M4ALL's core values

• Develop and implement strategies for pilot plant operations, ensuring alignment with the organization's goals and regulatory requirements.

• Coordinate with internal and external stakeholders to ensure successful pilot plant design, construction, commissioning, and operation.

• Deploy depth of understanding for scientific principles required for manufacturing intermediates and drug substances, including the interaction of chemistry and equipment. Instill it in the organization in your stewardship.

Problem-Solving and Troubleshooting:

• Provide technical support to manufacturing operations to address and resolve process-related issues and deviations - with an emphasis on speed, agility, and decisiveness

• Develop and implement root cause analysis and corrective action plans.

Regulatory Compliance:

• Ensure that manufacturing processes comply with regulatory requirements and guidelines.

• Support regulatory submissions and inspections

Collaboration and Communication:

• Demonstrate strong communication (oral, written), organizational, and leadership skills

• Collaborate with cross-functional teams - including R&D, Quality Assurance / Quality Control, Regulatory Affairs, and Business Operations, to ensure alignment and effective communication.

• Foster a culture of teamwork and continuous improvement.

• Set clear goals and expectations for team members, inspire and motivate them to achieve their best, provide opportunities for professional development, and manage performance effectively to ensure individual and team success.