Manufacturing Supervisor (2nd/3rd Shift)

The Manufacturing Supervisor is accountable and responsible for leading the manufacturing team at the Nashville, TN site. This is an exciting opportunity to contribute to the buildout and qualification of a new manufacturing facility for Aseptic Formulation and Filling to establish a state of art manufacturing operation. The Manufacturing Supervisor will report to the Manager of Manufacturing Operations. The position will be located in Nashville, TN.

Responsibilities

• 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
• Expected to develop cross-functional knowledge and qualify on processes to support operations as needed.

Requirements

• 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
• Ability to operate equipment utilized in aseptic operations, including HMI controls
• 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

Shifts

• 1st Shift : 7:00am - 3:30pm (Monday - Friday)
• 2nd Shift: 3:00pm - 11:30pm (Monday - Friday)
• 3rd Shift: 11:00pm - 7:30am (Sunday - Thursday)
• Weekend Day Shift: 7:00 AM-7:00 PM (Saturday-Monday)
• Weekend Night Shift: 7:00 PM-7:00 AM (Friday-Sunday)

Physical Requirements

ADA Accommodation Notice

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Requirements

• Ability to safely wear and work in a PAPR hood and associated equipment weighing approximately 2 to 3 pounds during assigned tasks.

• Ability to perform sustained physical activities, including standing, walking, bending, reaching, lifting, and handling manufacturing equipment while wearing required respiratory protection and personal protective equipment (PPE).

• Ability to wear and operate a Powered Air-Purifying Respirator (PAPR) for extended periods, up to 4 to 6 hours per shift, while performing manufacturing, equipment cleaning, and sanitization activities.

• Ability to wear required PPE, including pharmaceutical gowning, respiratory protection, safety glasses, chemical-resistant gloves, and additional protective equipment as required by operational and safety procedures.