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Manufacturing Specialist- Operational Excellence

United States - Maryland - FrederickRegular

Descripción del trabajo

The Manufacturing Specialist supports the Manufacturing organization by leading operational excellence initiatives, driving process efficiencies, and managing key workforce and departmental initiatives. This role requires strong project management capability, cross‑functional collaboration, and a structured, results‑oriented approach.

Schedule: Monday through Friday, 8:30 a.m. to 5:30 p.m., with occasional weekend or on‑call coverage
Department: Manufacturing
Reports to: Manufacturing Associate Director

Key Responsibilities

Operational Excellence and Project Leadership

  • Lead operational excellence initiatives across the Manufacturing department.

  • Manage the Manufacturing project review board and drive cross‑functional process improvements.

  • Develop project plans, schedules, governance structures, communication plans, and documentation standards.

  • Oversee project timelines, risks, deliverables, and stakeholder updates.

  • Lead cross‑functional teams to complete project tasks and milestones.

  • Create planning and logistics tools using MS Project, spreadsheets, and Smartsheet.

Workforce Planning and Departmental Support

  • Manage workforce planning, hiring, onboarding, and goal setting for the department.

  • Support full‑cycle recruiting activities, including role definition, interviewing, selection, and onboarding.

  • Track and manage annual and quarterly departmental goals aligned to business strategy.

  • Translate business objectives into actionable plans and measurable outcomes.

  • Monitor manufacturing metrics and KPIs, adjusting priorities and resources as needed.

  • Drive accountability for results across the team.

  • Collaborate with cross‑functional leaders to align goals and dependencies.

  • Communicate department priorities, progress, and challenges to senior leadership.

Basic Qualifications

  • MA/MS with 3 or more years of cGMP Manufacturing, Manufacturing Leadership, or Operations experience, or

  • BA/BS with 5 or more years of related experience, or

  • Associate degree with 7 or more years of related experience, or

  • High school diploma with 9 or more years of related experience

Preferred Qualifications

  • Bachelor’s degree in Life Sciences with project management or production experience required; logistics or planning certification preferred.

  • Minimum of 4 years of pharmaceutical industry experience with demonstrated project management capability.

  • Strong process‑optimization mindset and technical aptitude.

  • Proficiency in MS Office and Smartsheet.

  • Critical attention to detail and strong communication skills.

  • Ability to work independently in a fast‑paced environment with shifting priorities.

  • Experience with performance management systems and workforce planning.

  • Proactive, adaptable, and willing to take on responsibilities outside of initial scope.