MSAT Director

Duties and Responsibilities

• Accountable for technology transfer and product introduction activities supporting clinical and commercial manufacturing for oral solid dosage forms
• Owns process lifecycle management activities including process technology transfer, cleaning, validation strategy, process monitoring, continuous improvement, and regulatory support
• Collaborates with process development teams to define new processes, leading up to process performance qualification batches
• Provides technical support for investigations and may lead continuous improvement activities and/or corrective and preventative actions that result from investigations
• Identifies, assesses, and mitigates technical, operational, and project-related risks while ensuring long-term process reliability, compliance, and operational excellence
• Builds, develops, and leads a high-performing MSAT organization while providing strategic updates, readiness assessments, and recommendations to senior leadership and project governance teams
• Integrates with the senior leadership to develop and support Serán’s goals and objectives
• Scope of work may increase to align with company initiatives
• Other related duties as assigned

Required Skills and Abilities

• Demonstrated hands-on experience with relevant unit operations, including spray drying, granulation, tablet compression, capsule filling, related powder handling techniques, and clean-in-place systems
• Demonstrated experience supporting or leading drug product manufacturing processes for oral solid dosage forms, including process scale-up, technology transfer, process validation and
• robustness, commercial manufacturing support, and lifecycle management; Experience performing these activities within a Contract Manufacturing Organization is preferred
• Strong knowledge of GMP manufacturing operations, regulatory requirements, commissioning, qualification, validation, process performance monitoring, technology transfer, and inspection readiness
• Experience collaborating across different departments that may include Manufacturing Operations, Quality Assurance, Quality Control, Project Management, Engineering and Facilities, and Process Development
• Demonstrated success building and developing high-performing technical teams while driving operational excellence, continuous improvement, and organizational readiness
• Excellent communication, strategic planning, and risk management skills, with experience presenting to executive leadership, customers, and external stakeholders
• Excellent proactive problem-solving and analytical skills with the ability to create a strong, team-based environment
• Communicates effectively and maintains productive relationships with coworkers, clients, and other contacts outside the Company
• Accepts feedback from a variety of sources and constructively manages conflict

Education and Experience

• Bachelor’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or related field is required; advanced degree is preferred
• 10 years of progressive experience in pharmaceutical industry, with experience in leadership roles
• 4 years of experience either working directly in a GMP environment or providing technical support for GMP activities

Physical Requirements

• Prolonged periods of sitting or standing at a desk and working on a computer
• Must be able to lift 15 pounds at a time
• Adheres to consistent and predictable in-person attendance