MSAT Director

Serán BioScience; Bend (OR); Sur place; USD 180 000 - 240 000; Plein temps

Avantages offerts par ce poste

Paid time off

Retirement plan

Health insurance

Life insurance

Employee assistance program

Résumé du poste

Serán BioScience seeks a senior MSAT leader to direct technology transfer and lifecycle management for oral solid dosage manufacturing. You will work with Process Development, Manufacturing Operations, Quality, EHS, and leadership to align technical strategies with company goals.

The role supports a greenfield project and ongoing process verification after commercial launch. You will oversee cross-functional collaboration, risk management, and continuous improvement, driving manufacturing

Qualifications

• 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 leadership roles.
• 4 years of experience in GMP environment or providing GMP technical support.

Responsabilités

• Accountable for technology transfer and product introduction activities for oral solid dosage forms.
• Owns process lifecycle management including transfer, cleaning, validation strategy, monitoring, and regulatory support.
• Collaborates with process development to define new processes and lead performance qualification batches.
• Provides technical support for investigations and leads improvement or CAPA activities.
• Identifies and mitigates technical, operational, and project risks for long-term reliability.
• Builds and leads a high-performing MSAT organization and provides updates to senior leadership.

Connaissances

Process transfer

Spray drying

Granulation

Tablet compression

Capsule filling

Clean-in-place

GMP operations

Technology transfer

Process validation

Risk management

Leadership

Cross-functional collaboration

Strategic planning

Executive communication

Formation

BS in Chemistry

BS in Chemical Engineering

BS in Pharmaceutical Sciences

Advanced degree preferred

10 years pharma industry

GMP leadership experience

4+ years GMP environment support

Description du poste

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 developandsupportSerán’sgoals andobjectives
• 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 createa strong,team-based environment
• Communicates effectively andmaintainsproductive 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 sittingor standingat 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

Visit https://www.seranbio.com/careers to learn more about company culture and the community of Bend, Oregon.

Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

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