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
