Manager, Project and Planning
- 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
- Manufacturing training and curricula management
- 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
- 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
- Experience directly supporting manufacturing
- 6-10 years' experience in manufacturing operations
- Previous experience leading others in a manufacturing facility
- Experience working in a changing, project-driven organization
- 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
- 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
- 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
- Competitive compensation aligned with experience and impact
- Comprehensive health benefits and retirement plan options
- Generous paid time off and company-recognized holidays
- Leadership development, coaching, and career progression pathways
- Opportunities to lead high-visibility operational initiatives and continuous improvement projects
- Inclusive culture that values diverse perspectives, psychological safety, and work-life balance
- Tools, training, and cross-functional exposure to support long-term career growth
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