Downstream Supervisor (Biologics)

About the role

Led a shift team and responsible for manufacturing bulk drug substance in a 24/7 operational facility. Role may require flexibility with working hours.

Responsibilities

• Supports Factory Acceptance Testing (FAT) at the vendor site as required
• Supports Site acceptance Installation Verification (IV), Operational Verification (OV), and Performance Qualification (PQ) testing, including protocol generation, as applicable
• Performs other operational readiness tasks such as: document review/approval, team onboarding, and materials management
• Supervises manufacturing associates on technical and operational topics, such as: area unit operations and equipment
• Administers company policies, such as, but not limited to: travel & expense, time reporting, and time off that directly impact employees
• Provides on-the-floor leadership for a shift team of up to 7-10 manufacturing associates
• Captures the manufacturing schedule through daily shift assignments, lead daily huddles, and manages escalations
• Fosters an inclusive, people-first culture with regular communication, conducting 1:1s on a defined cadence with direct reports
• Maintains a safe and cGMP compliant environment by ensuring direct reports have correct and up-to-date training
• Supports manufacturing investigations and continuous improvement projects
• Coordinates with other functional areas for additional activities requiring access to the manufacturing space and equipment, such as but not limited to: maintenance, calibration activities and the use of manufacturing equipment
• Administers company policies, such as but not limited to: time reporting, time off, shift policies, and inclement weather that directly impact manufacturing employees
• Performs other job as assigned

Requirements

• High School Diploma or GED with 8 years of experience from a similar role in large pharma/biotech operations or projects
• Bachelor's Degree in Life Sciences with 4+ years of experience from a similar role in large pharma/biotech operations or projects
• Associates Degree in Life Sciences and 6+ years of experience from a similar role in large pharma/biotech operations or projects
• Military Experience of equivalence
• Experience in manufacturing of biological products, familiar with GMP/GLP requirements
• Previous experience leading, supervising or managing others

Qualifications

• High School Diploma or GED
• Bachelor's Degree in Life Sciences
• Associates Degree in Life Sciences
• 8+ years of experience from a similar role in large pharma/biotech operations or projects
• 4+ years of experience from a similar role in large pharma/biotech operations or projects
• 6+ years of experience from a similar role in large pharma/biotech operations or projects
• Military Experience of equivalence
• Experience in manufacturing of biological products, familiar with GMP/GLP requirements
• Previous experience leading, supervising or managing others

Skills

• Leadership
• Team Management
• Operational Readiness
• Quality Assurance
• Project Management
• Continuous Improvement
• Training and Development
• Conflict Resolution
• Communication

Benefits

• Dynamic Work Environment
• Genki Culture
• Global Headquarters in Tokyo
• Proximity to Raleigh’s Tech Scene
• Healthcare, Electronics, Business Innovation, Imaging Segments
• Group Purpose of “Giving Our World More Smiles”

Pay

• Competitive Salary

Schedule

• Rotating Shifts