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.
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
Benefits Summary:
Serán employees accrue over four weeks of paid time off annually. Employer contributions to a retirement account begin after 90 days and do not require an employee match or vesting period. Various health plans allow employees to find the best coverage for their individual or family needs with minimal employee contributions. Serán covers each employee with basic life and long-term disability, giving access to increase or add coverage. An Employee Assistance Program provides support for all things related to our employees' wellbeing, along with access to pet insurance.
The Corporate Headquarters of Serán BioScience are located at 63047 Layton Ave, Bend, OR 97701
