Manager - Manufacturing Services, Swing Shift (Multiple Positions)

Role Summary

Manager - Manufacturing Services, Swing Shift (Multiple Positions). Provide leadership and guidance to the Manufacturing Services team supporting 24/7 operations, including Raw Material and Solution Logistics, Weighing and Dispensing, Buffer/Media Solution Preparation, Parts Washer, and Autoclave. This role works a 12-hour 2-2-3 shift from 9:30 am to 10:00 pm and may require overtime, inclement weather, and holidays as needed. You will hire and train external workers, partner with a multidisciplinary team, and drive safety, quality, and continuous improvement across the department.

Responsibilities

• Lead a diverse and impactful team of External Workers in GMP operations
• Be responsible for the safety and quality culture of the department and champion continued improvement
• Monitor and take appropriate actions to ensure adequate warehouse capacity is available
• Oversee inventory control and cycle count processes
• Serve as owner of Material Transfer Equipment (e.g., preventative maintenance, operability)
• Own and/or provide input and support for quality system records (deviations, change control records, CAPA and SOPs) and other records (e.g., business continuity plan, user requirement specifications and risk assessments)
• Assess impact of new requirements, changes, processes, and regulations on the department
• Align with the broader organizational strategy and deliver continuous improvement
• Support regulatory inspections for areas of responsibility, evaluating complex compliance issues and developing playbooks for inspections

Qualifications

• Required: High School diploma/GED and 12 years of Manufacturing & Operations experience OR Associate's degree and 10 years of Manufacturing & Operations experience OR Bachelor's degree and 5 years of Manufacturing & Operations experience OR Master's degree and 3 years of Manufacturing & Operations experience OR Doctorate degree
• And Required: experience directly managing people and/or leading teams, projects, programs, or directing allocation of resources (managerial experience can run concurrently with technical experience)
• Preferred: Managerial experience and/or technical expertise in a GMP manufacturing drug substance plant that utilizes Single Use technology, dispensing, inventory control
• Preferred: Expertise in ERP-SAP and MES and inventory management
• Preferred: Cross-functional work experience in Single Use Technology, Supply Chain, Process Development, and Quality or Engineering
• Preferred: Excellent communication and change management skills, with drive, urgency, high energy, and problem-solving abilities
• Preferred: Ability to forge and maintain strong relationships with other functional areas
• Preferred: Ability to develop and mentor staff to broadly build inventory management expertise within internal site teams

Skills

• GMP operations
• External workforce management
• Inventory control and cycle counting
• Material Transfer Equipment ownership and maintenance
• Quality system records (deviations, change control, CAPA, SOPs)
• Regulatory inspections support
• Strong communication and change management

Additional Requirements

• Ability to work a 12-hour shift (2-2-3) from 9:30 am to 10:00 pm
• Willingness to work during inclement weather, some holidays, and overtime as required
• Regular attendance to meet legitimate business needs