The Manufacturing Manager leads all aspects of manufacturing operations per assigned location and product type. Managers may work in medical device manufacturing or may support the manufacturing of drug products. The Manager may support aseptic, non-aseptic operation activities as well as lyophilization activities. As assigned, the manufacturing manager will be responsible for activities such as component preparation, product formulation, aseptic filling, stoppering, capping and lyophilization activities. The incumbent is also expected to support media fill activities and aseptic qualifications, audits, validation assistance, and the ability to maintain a cGMP environment, as well as participate in responses to internal and external audits. Manage formulation cleaning/decontamination, assembly, sterilization, high-level disinfection and distribution. Manages inventory and supplies supporting departmental activities. The manager is also tasked with developing and ensuring compliance with departmental budget, and to work collaboratively with other departments to create and ensure process and cost efficiencies. Excels in customer service, ensuring the highest standards for both internal and external customer satisfaction. Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned. 3 Responsible for managing and directing staff to ensure proper and continuous function of all manufacturing operations and adherence to the established schedules 3 Leads the safety initiatives for manufacturing and ensure department compliance with all PCI safety procedures, processes. 3 Ensures that all operations of the drug/product cleanroom areas are being performed in accordance with cGMP and current regulatory guidelines as well as all applicable SOPs 3 Supports the production schedule to meet requirements for staffing, work schedules, planning activities, and equipment maintenance 3 Directs personnel to complete and review all associated batch record and SOP documentation 3 Writes, reviews/approves investigation, OOT/OOS, EEIs and completion of deviation reports 3 Writes, reviews/approves change control orders and CAPAs 3 Coordinates assistance for Validation protocols, and other process studies. Coordinates activities for process enhancement projects and supports new product development projects 3 Ensures training of operators to learn techniques for product formulation, preparation of materials/products, aseptic technique, contamination control, gowning, , labeling and packaging 3 Oversees control of product manufacturing operation areas including cleanrooms, component prep and sanitization, filling, and packaging activities 3 Works closely with Validations, Facilities, Quality, Project Management and Senior Management to ensure the needs of all functions are met 3 Other duties as assigned, or as business needs require Special Demands: The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which may be made to enable individuals with disabilities to perform the essential functions. 3 Ability to stand, sit or remain in the same position for extended periods of time 3 May be required to travel between sites 3 Follow written instructions 3 Able to train others 3 Able to work in a highly complex environment with competing demands and priorities Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 3 Proficiency in pharmaceutical process development for aseptically produced products or medical device manufacture 3 Working knowledge of pharmaceutical facilities, lyophilization technology and manufacturing equipment as well as cleanrooms 3 Strong troubleshooting and root cause analysis skills 3 Able to effectively lead and coordinate multiple, complex requests/projects and allocate resources effectively 3 Able to effectively deal with complex technical issues using structured analysis, methodology and articulates clear and concise direction to other operations staff 3 Excellent oral and written (reports) communication skills 3 Strong organization and leadership skills 3 Self-motivated with a drive for excellence; able to inspire and motivate the staff 3 Honesty, integrity, respect and courtesy with all colleagues 3 Creative and can work with minimal supervision following internal procedures balanced with independent thinking 3 Resilient through operational and organizational change 3 Strong commitment to excellence and quality with a positive working attitude 3 This Manager will be responsible for the activities and schedules to meet designated timelines as well as communicating with the clients on technical aspects of the project, if needed. Additionally, this Manager will be responsible for communicating the status of the project with the rest of the organization including Manufacturing, Project Management, and the entire Quality team. 3 Responsible for revising and creating SOP's pertinent to daily tasks in PCI operations. Responsible for directing activities of Manufacturing Technicians. Assist in the preparation of staff evaluations. Must be able to observe and identify potential issues and address satisfactorily. 3 TRAVEL - Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. 3 BA science degree, or equivalent 3 A minimum of 5 years relevant pharmaceutical or medical device manufacturing experience 3 Proven aseptic process leadership experience 3 Must understand cGMP and WW regulatory requirements (e.g. EU) for parentals or familiar with working in ISO 5 and 6 areas. Gowning experience necessary. 3 Understanding of basic contamination and aseptic technique and any formal training would be beneficial. #LI-LL1