Manager, Project and Planning

About the role

As Manager, Manufacturing Support, you’ll build and lead a talented team, oversee critical manufacturing support activities, and partner cross-functionally to ensure operational readiness, continuous improvement, and inspection readiness across a dynamic, cGMP environment.

Responsibilities

• Provide oversight and lead operational readiness projects, including but not limited to:
• Lead the creation or transfer (from an existing large-scale facility) of manufacturing support team business processes to ensure GMP operational readiness
• Lead, manage, and build the manufacturing support team
• Administer company policies that directly impact employees
• Complete required administrative tasks (e.g., time card approvals, time off approvals, expense reports)
• Perform other duties, as assigned
• Manage, lead, and develop direct reports within the manufacturing support team while overseeing, organizing, and coordinating team tasks
• Foster an inclusive, people-first culture by creating meaningful development plans with direct reports and conducting regular 1:1s and skip-level 1:1s
• Provide oversight and coordinate non-batch activities and collaborate cross-functionally, including:
• Ownership of manufacturing change controls and corrective and preventive actions (CAPAs)
• Short flow investigations and management of alert/action limits
• Detailed batch manufacturing schedules
• Campaign materials readiness and coordination
• Ensure continuous improvement; drive escalation and mitigation of manufacturing issues
• Maintain and administer manufacturing training and curricula
• Act as functional lead for regulatory inspections and audits
• Administer company policies that directly impact employees
• Complete required administrative tasks (e.g., time card approvals, time off approvals, expense reports)
• Perform other duties, as assigned

Requirements

• High School diploma or GED with 10 years related experience OR Bachelor’s Degree with 6 years related experience OR Master’s Degree with 4 years of related experience
• 4+ years of experience managing, leading, and developing people
• Experience with regulatory inspections, investigations and change management

Qualifications

• Minimum Qualifications (must meet one of the following):
• High School diploma or GED with 10 years related experience
• Bachelor’s Degree with 6 years related experience
• Master’s Degree with 4 years of related experience
• Preferred Qualifications:
• 6–10 years’ experience in manufacturing operations
• Previous experience leading others in a manufacturing facility
• Experience working in a changing, project-driven organization
• Licenses/Certifications: Lean certification or similar certifications
• Experience with regulatory inspections, investigations and change management preferred
• Experience in pharmaceutical / biological manufacturing operations preferred
• Experience leading others in a pharmaceutical/biological manufacturing facility preferred

Skills and Abilities

• Ability to collaborate with manufacturing and other functional areas
• Strong organizational skills and demonstrated project management capabilities
• Actively champions continuous improvement practices and ideas
• Advanced understanding of good manufacturing practices (GMP), inspection requirements, safety, and manufacturing operations
• Ability to coach, lead, and develop individual contributors

Physical Work Environment Requirements

• Ability to stand and sit for prolonged periods
• Ability to move objects up to 33 lbs (10 lbs frequently)
• Ability to discern audible cues
• May require occasional work in production-adjacent spaces; no respiratory protection or powered industrial truck operation required for this role
• No routine work at heights, in small/enclosed spaces, or in extreme temperatures