Manufacturing Supervisor

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

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing servicesto pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!

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.

At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement. We aspire to unlock the potential in every person, every process and every molecule – from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.

We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team!

August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.