Manufacturing, Science And Technology Director

We are looking for a highly motivated, results-driven Manufacturing, Science, and Technology (MS&T) Director to join our team who will play a key role in optimizing product performance throughout its lifecycle by leading cross-functional efforts in analytical development, formulation improvements, and process optimization.

The Manufacturing, Science, and Technology (MS&T) Director will oversee the technical and strategic aspects of manufacturing processes, lifecycle management (LCM), analytical development, and formulation.

This role ensures the successful integration of product development activities into commercial manufacturing, drives continuous improvement initiatives, addresses technical challenges, and ensures compliance with regulatory requirements.

Key Responsibilities:

Leadership and Lifecycle Management (LCM):

• Develop and implement strategies for the lifecycle management of products, ensuring high-quality manufacturing and sustained process performance throughout the product lifecycle.
• Lead the MS&T team by providing guidance on technical problem-solving, supporting professional development, and aligning team efforts with organizational goals.
• Build and maintain strong cross-functional partnerships with R&D, Quality, Regulatory Affairs, and Commercial Manufacturing to drive product improvements, extensions, and innovations.

Analytical Method Development and Support:

• Oversee the development, optimization, validation, and transfer of analytical methods for raw materials, in-process controls, and finished products.
• Ensure all analytical methods are robust, reproducible, and compliant with global regulatory guidelines.
• Support troubleshooting of analytical challenges in collaboration with Quality Control (QC) and R&D teams.
• Drive the implementation of innovative analytical technologies to enhance product characterization and quality control capabilities.

Formulation Development and Optimization:

• Oversee the design, development, and optimization of robust formulations to ensure product performance, stability, and consistent quality across its shelf life.
• Lead initiatives to improve existing formulations, enhancing product efficacy, stability, and manufacturability.
• Collaborate with R&D and manufacturing teams to seamlessly scale-up formulations from development to commercial production.

Technology Transfer and Scale-Up:

• Lead and manage technology transfers of manufacturing processes, analytical methods, and formulations from R&D to commercial-scale production.
• Ensure that processes and methods are scalable, cost-efficient, and aligned with commercial manufacturing capabilities.
• Act as the technical lead for process and analytical qualification, validation, and regulatory filings.

Continuous Improvement and Innovation:

• Identify opportunities for process improvements, cost reductions, and efficiency gains in manufacturing and testing processes.
• Drive the introduction of new technologies, methodologies, and process enhancements across the product lifecycle.
• Utilize tools such as risk assessments, statistical analysis, and process data to drive data-informed decision-making and implement corrective and preventive actions.

Regulatory and Quality Compliance:

• Ensure all development, manufacturing, and analytical processes meet global regulatory and quality standards (e.G., FDA, EMA, ICH).
• Prepare and review documentation for regulatory submissions, inspections, and audits, including method validation reports, comparability studies, and process validation reports.
• Support investigations, resolve deviations, and identify root causes to ensure continuous compliance.

Cross-Functional Collaboration:

• Partner with R&D, Quality, Manufacturing, and Supply Chain teams to align manufacturing and technical strategies with overall business objectives.
• Serve as the technical liaison for external manufacturing partners and analytical and formulation development organizations.
• Foster collaboration between internal and external stakeholders to ensure the efficient and effective development, manufacturing, and commercialization of products.

Team Development and Mentorship:

• Lead, manage, and mentor a team of scientists, engineers, and technical specialists in manufacturing sciences, analytical development, and formulation.
• Foster a culture of innovation, collaboration, and continuous learning, ensuring team members are empowered to excel in their roles.

Qualifications and Skills:

• Bachelor’s degree in Chemical Engineering, Biochemistry, Pharmacy, Biotechnology, or related field (Master’s or Ph.D. strongly preferred).
• 10+ years of experience in manufacturing, analytical development, formulation, or technical operations within the pharmaceutical or biotechnology industry.
• Proven track record in lifecycle management, process optimization, and technology transfer, including experience with analytical method and formulation development.
• Deep understanding of GMP-regulated environments and familiarity with global regulatory guidelines (FDA, EMA, ICH).
• Hands-on knowledge of advanced analytical techniques (e.G., HPLC, GC, spectroscopy) and stability studies.
• Expertise in process development, scale-up, and validation for commercial manufacturing.
• Strong project management skills with the ability to prioritize competing demands effectively.
• Exceptional leadership and team-building capabilities, with the ability to inspire and mentor cross-functional teams.
• Excellent problem-solving and strategic thinking skills to tackle complex technical challenges.
• Solid understanding of regulatory requirements and ability to ensure compliance across development, manufacturing, and analytical activities.

Angelini Pharma is an equal Opportunity Employer.

We believe that diversity is a huge value that contributes to individual and company success. We are committed to create a diverse and inclusive environment.