1. JOB SUMMARY

Responsible for the direct management/supervision of production supervisors. Provide leadership and decision making for the Production department and oversee all aspects of prep, formulation, setup and operation of equipment and processes associated with sterile filling.

2. ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

• Oversee all equipment preparation, equipment operation, product formulation, and clean room procedures to ensure that Emergent SOPs and policies are followed and that the highest standards are met.
• Monitor and ensure all personnel comply with CGMP regulations, adhere to Emergent policies, safety regulations, and adhere to Emergent SOP and Batch Record directions.
• Develop and train Technicians and Supervisors through counseling and guidance. Ensure adequate training is provided to Technicians in order for them to complete their job assignments.
• Interface with the Quality Assurance, Maintenance, and Materials Management departments to resolve production, supply, and equipment issues. Document issues through deviations and assist with investigations, as necessary.
• Effectively troubleshoot equipment during operation to ensure effective and efficient operations while maintaining high quality and service to the client.
• Interact with clients and auditors to provide information and technical expertise on Component Preparation, Formulation, and Filling operations.
• Provide input and help develop manufacturing schedule to ensure optimal use of resources.
• Review documentation and ensure that it complies with Good Documentation Practices.
• Review, provide technical expertise for, and assist in development of batch records to comply with CGMP regulations and to efficiently use Emergent resources.
• Track and trend expenditures to ensure budget and client requirements are met.
• Assist the Validation and Maintenance staff with the operation and execution of engineering projects. Provide technical expertise for these projects. Review and approve protocols and reports.
• Collaborate with Quality Assurance On the Floor (QAOTF) to identify and improve GDP and GMP practices that will result in reducing deviation creation and increase Right First Time (RFT).
• Identify process improvements withing manufacturing area and partner with Operational Excellence (OE) team to increase capacity and drive efficiencies.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

• BA/BS in science or technical field with a minimum of 7 years experience in CGMP or regulated environment
• Minimum of 5 years of supervisory experience
• Lyophilization and Terminal Sterilization experience preferred.
• Restricted Access Barrier (RABS) or Isolator experience preferred.