Associate Director/Director, Manufacturing Science and Technology

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.

Required Qualifications for Success:

• Master’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences, Pharmaceutical Engineering or a related field. Ph.D. preferred
• Minimum of 10 years of experience in pharmaceutical manufacturing (drug substance / active pharmaceutical ingredients), with a focus on manufacturing science and technology (MSAT)
• Experience in the successful design, development, and commissioning of regulator-approved drug substance manufacturing facilities (experience with Early Phase clinical manufacturing facilities is a plus)
• Strong knowledge of regulatory requirements and guidelines (e.g., FDA, EMA)
• Proven experience in leading innovation and managing teams, with a demonstrated ability to develop talent and foster a culture of teamwork and continuous improvement
• Excellent problem-solving and troubleshooting skills
• Strong leadership and project management abilities
• Excellent communication and interpersonal skills
• Ability to work effectively in a fast-paced, collaborative environment
• Willingness to travel domestically and internationally (anticipated up to 10% of time)
• Demonstrated ability to use good judgment and decision making, responding calmly and effectively in crisis situations
• Unwavering commitment to aligning and adhering to M4ALL’s core values and purpose
• Exhibit high ethical standards and promote respectful behavior within the organization
• Possess a strong cultural competency with a dedication to valuing diversity and contributing to an inclusive working environment
• Must be able to provide own transportation to travel occasionally between multiple worksites during the initial phases of the project

Title Distinction:

This job posting welcomes candidates with diverse levels of experience. We will consider hiring at either the Associate Director or Director level based on selected candidate's qualifications and experience. The Director level will be distinguished by advanced expertise and extensive experience in developing and executing long-term innovation strategies, embracing cutting-edge technologies, and leading complex projects, programs, and teams.

Reporting Structure:

This role reports to the Head of Research & Development and is intended to be a key supervisory position as M4ALL continues to expand. 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.

Worksite Location:

The primary worksite for this role will be the early clinical-scale manufacturing facility (pilot plant) in Chesterfield, Virginia, which is currently under development. During the construction phase of the scale-up facility, this role will be based out of our downtown Richmond site and will require occasional travel between the two sites.

Starting Salary:

Up to $160,000, commensurate with qualifications

Life at Medicines for All:

A career with M4ALL offers an invaluable chance to contribute meaningfully to work centered around tackling critical global health challenges. Our working environment is collaborative and high-energy, with a mission-driven culture. The problems we hope to solve are immense, and we are just getting started on this journey Join us in making a lasting impact at the forefront of pressing health issues worldwide

VCU and M4ALL is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.