MSAT Director

Serán BioScience • Bend, OR

1d • Onsite

About The Position

The MSAT Director leads the Manufacturing Sciences and Technology (MSAT) team and oversees the transfer of robust, GMP-compliant manufacturing processes into Serán’s facilities for clinical and commercial production. As a member of the Commercial Steering Committee, the role will initially support the capital project for a greenfield manufacturing facility. After commercial launch, the role will support continued process verification.

The MSAT team drives continuous improvement of GMP systems and production capabilities and provides technical support for GMP investigations. The Director works closely with Process Development, Manufacturing Operations, Quality, EHS, and Company Leadership to align technical strategies with company goals. The scope of work may expand to support company initiatives.

Requirements

• Bachelor’s degree in Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a related field.
• 10 years of progressive experience in the pharmaceutical industry, including experience in leadership roles.
• 4 years of experience working directly in a GMP environment or providing technical support for GMP activities.
• Hands-on experience with relevant unit operations, including spray drying, granulation, tablet compression, capsule filling, powder handling techniques, and clean-in-place systems.
• Experience supporting or leading oral solid dosage drug product manufacturing processes, including process scale-up, technology transfer, process validation and robustness, commercial manufacturing support, and lifecycle management.
• Strong knowledge of GMP manufacturing operations, regulatory requirements, commissioning, qualification, validation, process performance monitoring, technology transfer, and inspection readiness.
• Experience collaborating across departments, potentially including 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, including experience presenting to executive leadership, customers, and external stakeholders.
• Proactive problem-solving and analytical skills, with the ability to foster a strong, team-based environment.
• Ability to communicate effectively and maintain productive relationships with coworkers, clients, and external contacts.
• Ability to accept feedback from varied sources and constructively manage conflict.
• Authorized to work for an employer in the United States; the company cannot sponsor or take over sponsorship of an employment visa.
• Able to meet the physical requirements of prolonged sitting or standing at a desk, working on a computer, lifting up to 15 pounds, and consistent, predictable in-person attendance.

Nice To Haves

• Advanced degree.
• Experience performing oral solid dosage manufacturing process activities within a Contract Manufacturing Organization.

Responsibilities

• Lead the MSAT team and oversee technology transfer and product introduction activities for clinical and commercial manufacturing of oral solid dosage forms.
• Own process lifecycle management activities, including process technology transfer, cleaning, validation strategy, process monitoring, continuous improvement, and regulatory support.
• Collaborate with process development teams to define new processes and lead work through process performance qualification batches.
• Provide technical support for investigations and potentially lead continuous improvement activities and corrective and preventive actions resulting from investigations.
• Identify, assess, and mitigate technical, operational, and project-related risks to support process reliability, compliance, and operational excellence.
• Build, develop, and lead a high-performing MSAT organization.
• Provide strategic updates, readiness assessments, and recommendations to senior leadership and project governance teams.
• Work with senior leadership to develop and support Serán’s goals and objectives.
• Support the capital project for a greenfield manufacturing facility and, following commercial launch, continued process verification.
• Perform other related duties as assigned.

Benefits

• Over four weeks of paid time off accrued annually.
• Employer contributions to a retirement account begin after 90 days and require no employee match or vesting period.
• Various health plans with minimal employee contributions.
• Basic life and long-term disability coverage, with the option to increase or add coverage.
• Employee Assistance Program supporting employee wellbeing.
• Access to pet insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Director