MSAT Director

This role serves as the leads the Manufacturing Sciences and Technology (MSAT) team to oversee the transfer of robust, GMP-compliant manufacturing processes into Serán’s facilities for clinical and commercial production. As a critical member of the Commercial Steering Committee, this role will initially support the capital project of a greenfield manufacturing facility currently underway. After commercial launch, the role will support continued process verification. The MSAT team also drives continuous improvements to GMP systems and production capabilities, and provides technical support for GMP investigations. This role will work closely with Process Development, Manufacturing Operations, Quality, EHS, and Company Leadership to align technical strategies with company goals.

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

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

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

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