Aseptic Manufacturing Lead — Fast-Growing CDMO

August Bioservices; Tennessee; Vor Ort; USD 85.000 - 110.000; Vollzeit

Zusammenfassung

August Bioservices, based in Nashville, TN, is seeking a Manufacturing Supervisor to lead the aseptic formulation and filling team at the Nashville site. You will oversee production activities, set schedules, and drive product quality in a state-of-the-art facility.

The role requires 4+ years of cGMP manufacturing experience with prior supervision, a Bachelor’s degree or equivalent, and ability to qualify in aseptic gowning.

Qualifikationen

• 4+ years of cGMP manufacturing experience; supervisor experience preferred
• Must qualify in Aseptic Grade A/B gowning
• Operate equipment used in aseptic operations and HMI controls
• Knowledge of cGMP regulatory requirements for aseptic manufacturing
• Ability to troubleshoot, analyze data, and recommend compliant actions
• Able to work in fast-paced environment and coordinate across functions
• Willing to work flexible hours on short notice
• Strong written and verbal communication and interpersonal skills

Aufgaben

• Accountable for production activities including equipment prep, formulation, filling, packaging and related processes
• Oversee manufacturing schedule and develop team KPIs
• Provide training, coaching, mentoring and discipline to team members
• Set team goals aligned with site and company objectives
• Lead deviation assessments and implement CAPAs
• Drive change controls for process improvements and CAPAs
• Establish on-the-job training plans for Manufacturing team
• Ensure personnel are qualified with cGMP requirements and PPE
• Maintain cleanroom environments to cGMP standards
• Develop and manage departmental goals and budgets
• Cross-train to support operations as needed

Kenntnisse

Leadership

Communication skills

Independent work

Problem solving

Ausbildung

Bachelor’s degree or equivalent pharma manufacturing experience

Tools

MS Office (Word, Excel, Outlook, PowerPoint)

Jobbeschreibung

August Bioservices, based in Nashville, TN, is seeking a Manufacturing Supervisor to lead the aseptic formulation and filling team at the Nashville site. You will oversee production activities, set schedules, and drive product quality in a state-of-the-art facility.

The role requires 4+ years of cGMP manufacturing experience with prior supervision, a Bachelor’s degree or equivalent, and ability to qualify in aseptic gowning.