Manufacturing Manager of Aseptic Filling Operations

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 services to 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 Manager of Aseptic Filling Operations is accountable and responsible for managing and coordinating all aspects of the aseptic filling operations at the Nashville, TN site. This is an exciting opportunity to contribute to the growth and qualification of a new state of the art manufacturing facility. The Manufacturing Manager will report to the VP Manufacturing Operations. The position will be located in Nashville, TN.

Responsibilities

• Accountable for startup and routine operation activities related to Aseptic Filling and Terminal Sterilization, which may span across multiple shifts. 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
• Works with Engineering and Technical Service teams to develop user requirements, and contributes to the selection of process equipment
• 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
• Expected to develop cross-functional knowledge and qualify on processes to support operations as needed.
• Develops and serves as a subject matter expert for all aseptic filling department processes
• Develops and manages departmental goals and corresponding budget in alignment with the corporate and site goals

Requirements

• 10-12 years of cGMP manufacturing experience and 4+ years in leading manufacturing teams.
• Bachelor’s degree required.
• Experience within CDMO Aseptic Manufacturing Operation is preferred
• Demonstrated leader in manufacturing with the ability to lead and develop teams
• Must be able to qualify in Aseptic Grade A/B gowning
• Comprehensive knowledge of global cGMP regulatory requirements for Aseptically Manufactured products
• Experience with cGMP Manufacturing is required
• Demonstrated ability to troubleshoot, solve problems, synthesize data, summarize outcomes and provide recommendations on a compliant path forward
• Demonstrated ability to successfully execute responsibilities in a fast-paced environment, collaborating across corporate functions and multiple stakeholders
• Demonstrated ability to perform long-term project planning, team building, budgeting and operational excellence
• 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
• Ability to operate equipment utilized in aseptic operations, including HMI controls
• Excellent computer skills in Microsoft Word, Excel, Outlook, and PowerPoint

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