Manufacturing Supervisor (2nd/3rd Shift)

August Bioservices, LLC · Nashville, TN · 1 mo ago

On-siteManufacturingFull-time

Accountable for production activities spanning equipment preparation, formulation, filling, packaging and other related processes.
Primary container platforms include Vials, Syringes, Bags and Tubes.
Responsible for execution of the manufacturing schedule and oversight and development of the team and related KPIs.
Provides training, coaching, mentoring and discipline to team members to ensure development as individuals contributing to the goals of the department and company.
Sets goals for team members to deliver the vision of the manufacturing operation aligned with site and company objectives.
Leads deviation assessments and implements corrective actions (CAPAs).
Drives change controls for process improvement / changes or CAPAs.
Establishes requirements and develops on-the-job-training plans for the Manufacturing team.
Ensures personnel are qualified and proficient with applicable cGMP requirements and internal governing procedures.
Maintains cleanroom environments to cGMP requirements.
Develops and manages departmental goals and corresponding budget in alignment with the corporate and site goals.

4+ years of cGMP manufacturing experience; previous supervisor experience preferred.
Bachelor’s degree is preferred or equivalent pharma manufacturing experience.
Must be able to qualify in Aseptic Grade A/B gowning.
Comprehensive knowledge of cGMP regulatory requirements for aseptic manufacturing.
Demonstrated ability to troubleshoot, solve problems, synthesize data, summarize outcomes and provide recommendations on a compliant path forward, and own deviation investigations.
Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across corporate functions and multiple stakeholders.
The ability to work flexible hours on short notice due to manufacturing demand.
Self-starter and ability to work independently.
Strong written/verbal communication and presentation skills.
Team player with well-developed interpersonal skills and excellent organizational skills.
Excellent computer skills in Microsoft Word, Excel, Outlook, and PowerPoint.

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