MSAT Supervisor

Job Title:
MSAT Supervisor

Job Overview:
The MSAT Supervisor will oversee technical support activities across technology transfer, process validation, GMP floor support, and continued process verification. This role ensures robust, efficient, and compliant manufacturing processes while driving optimization and continuous improvement initiatives. The Supervisor will provide leadership to a small team of engineers and technical writers, guiding technical decision-making, troubleshooting, and process enhancements to maintain product quality and regulatory compliance.

Job Responsibilities:

• Lead and manage a team of Tech Services Engineers and Technical Writers specializing in drug product formulation, single-use systems, mixing, filtration, filling, and visual inspection.

• Provide leadership and technical direction to support manufacturing operations and decision-making.

• Oversee technical troubleshooting and investigations to drive effective root cause analysis, product impact assessments, and CAPA implementation.

• Implement process improvements through data-driven analysis and scientific principles.

• Provide technical oversight to Operations and Validation teams in support of process performance qualification (PPQ) and continued process verification (CPV).

• Drive production excellence to ensure commercial scalability and regulatory compliance.

• Author and review regulatory documentation, including information packages and submissions.

• Represent MSAT in cross-functional project teams and serve as a subject matter expert to clients.

• Collaborate with cross-functional teams to troubleshoot and resolve complex technical issues.

• Perform additional responsibilities as assigned.

Qualifications:

• Bachelor’s degree in science, engineering, or a related scientific discipline required.

• Master’s degree in science, engineering, or related field strongly preferred.

• 5+ years of GMP experience in pharmaceutical or biologics manufacturing processes and equipment.

• 2+ years of leadership or mentorship experience required.

• Strong knowledge of regulated GMP manufacturing operations.

• Excellent communication, problem-solving, and leadership skills.