Accountable for production activities spanning equipment preparation, formulation, filling, packaging, and other related processes.
Responsible for execution of the manufacturing schedule and oversight.
Provides training, coaching, mentoring, and discipline to team members to ensure their 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
Bachelor’s Degree is preferred or equivalent pharma manufacturing experience
3+ years of cGMP manufacturing experience; previous supervisor experience preferredMust 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.