Manufacturing Science and Technology Leader
6 days ago
Medicines for All Institute is seeking a highly skilled Manufacturing Science and Technology (MSAT) leader to join our team. As a key member of our organization, you will be responsible for overseeing the implementation of robust and efficient manufacturing processes and the continuous advancement of our manufacturing assets and capabilities.
We are looking for a candidate with 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. The successful candidate will bring a highly collaborative mindset, stewarding cost-advantaged processes into Manufacturing in partnership with leaders across our departments.
Key Responsibilities:- 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
- 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
- Define scientifically robust, defensible control strategies for API manufacturing and reduce them to practice via unit operation requirements
- Manage the transfer of manufacturing processes from development to clinical and commercial production - internally, and to third-party manufacturing operations
- 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
- Anticipate commercial manufacturing challenges and implement appropriate product control strategies
- Provide technical leadership for technology transfers between Development and manufacturing sites
- 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
- Lead the design, construction, and commissioning of our first early clinical-scale manufacturing facility in Chesterfield County, Virginia
- Build, lead, and mentor a team of MSAT professionals - process engineers, process chemists, operators - fostering a culture of collaboration, aligned to our core values
- Develop and implement strategies for pilot plant operations, ensuring alignment with our organization's goals and regulatory requirements
- Provide technical support to manufacturing operations to address and resolve process-related issues and deviations
- Develop and implement root cause analysis and corrective action plans
- Ensure that manufacturing processes comply with regulatory requirements and guidelines
- Support regulatory submissions and inspections
- 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
- 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 our 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
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