MSAT Director: GMP Process Transfer & Manufacturing Lead

Serán BioScience; Bend (OR); Vor Ort; USD 180.000 - 240.000; Vollzeit

Benefits dieser Stelle

Paid time off

Retirement plan

Health insurance

Life insurance

Employee assistance program

Zusammenfassung

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

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

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

Ausbildung

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

Jobbeschreibung

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