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 Manager, Manufacturing 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 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.

August Bioservices, LLC

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