Overview
Headquartered in Nashville, TN, August Bioservices is a privately-owned, high-growth Contract Development Manufacturing Organization (CDMO) that provides drug discovery, drug formulation, and drug manufacturing services to pharma and biotech companies of all sizes. We support global health with a focus on advancing molecules to become life-changing therapies. We are investing in a two-phase expansion project, including a new state-of-the-art facility adjacent to our current site. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference, come grow with August.
The Manufacturing Supervisor is accountable and responsible for leading the 1st shift manufacturing team at the Nashville, TN site. This role contributes to the buildout and qualification of a new manufacturing facility for aseptic formulation and filling and reports to the Manager of Manufacturing Operations. The position is located in Nashville, TN.
Responsibilities
- Accountable for production activities spanning equipment preparation, formulation, filling, packaging and related processes. Primary container platforms include Vials, Syringes, Bags and Tubes.
- Execute the manufacturing schedule and oversee the development of the team and related KPIs.
- Provide training, coaching, mentoring and discipline to team members to support individual development and achievement of department and company goals.
- Set goals for team members to deliver the vision of the manufacturing operation aligned with site and company objectives.
- Lead deviation assessments and implement corrective actions (CAPAs).
- Drive change controls for process improvement, changes or CAPAs.
- Establish requirements and develop on-the-job training plans for the Manufacturing team.
- Ensure personnel are qualified and proficient with applicable cGMP requirements and internal procedures.
- Maintain cleanroom environments to cGMP requirements.
- Develop and manage departmental goals and the corresponding budget in alignment with corporate and site goals.
- 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 preferred or equivalent pharma manufacturing experience.Must be able to qualify in Aseptic Grade A / B gowning.Ability to operate equipment used 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 work effectively in a fast-paced environment, collaborating across corporate functions and multiple stakeholders.Ability to work flexible hours on short notice due to manufacturing demand.Self-starter with the ability to work independently.Strong written and verbal communication and presentation skills.Team player with strong interpersonal and organizational skills.Excellent computer skills in Microsoft Word, Excel, Outlook, and PowerPoint.At August Bioservices, our credo guides our culture. We strive for excellence, regulatory compliance, and responsible stewardship of our environment. We are committed to doing the right thing the first time and every time, and to being exceptional partners for our customers and communities.
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 hiring, promotion, discipline, or discharge decisions 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.
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