Manager, Manufacturing

pciservices; Bedford (NH); On-site; USD 90,000 - 130,000; Full time

Job summary

PCI is seeking a Manufacturing Manager to lead all aspects of manufacturing operations at our Bedford, NH site, supporting aseptic, non-aseptic, lyophilization, and drug/product manufacturing as assigned.

You will ensure cGMP compliance, manage budgets, coordinate with Validations, Quality, Facilities and Senior Management, mentor staff, and drive process improvements to achieve on-time production and high customer satisfaction.

Qualifications

• Proven experience leading manufacturing operations teams.
• Strong knowledge of cGMP and regulatory guidelines.
• Ability to manage budgets and drive cost efficiencies.
• Experience coordinating with Validation, Quality and Facilities teams.

Responsibilities

• Manage and direct staff to ensure continuous function of manufacturing operations and adherence to schedules.
• Lead safety initiatives for manufacturing and ensure department compliance with PCI safety procedures.
• Ensure cleanroom operations comply with cGMP and applicable SOPs.
• Support the production schedule for staffing, planning and equipment maintenance.
• Direct personnel to complete batch records and SOP documentation.
• Coordinate investigations, CAPAs, and change controls; support validation activities.
• Oversee training on product formulation, aseptic technique, contamination control and packaging.
• Collaborate with Validations, Facilities, Quality, Project Management and Senior Management.
• Other duties as assigned.

Skills

Staff management

Safety leadership

cGMP knowledge

Budget management

Cross-functional collaboration

Job description

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

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:

• Responsible for managing and directing staff to ensure proper and continuous function of all manufacturing operations and adherence to the established schedules
• Leads the safety initiatives for manufacturing and ensure department compliance with all PCI safety procedures, processes.
• 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
• Supports the production schedule to meet requirements for staffing, work schedules, planning activities, and equipment maintenance
• Directs personnel to complete and review all associated batch record and SOP documentation
• Writes, reviews/approves investigation, OOT/OOS, EEIs and completion of deviation reports
• Writes, reviews/approves change control orders and CAPAs
• Coordinates assistance for Validation protocols, and other process studies. Coordinates activities for process enhancement projects and supports new product development projects
• Ensures training of operators to learn techniques for product formulation, preparation of materials/products, aseptic technique, contamination control, gowning, , labeling and packaging
• Oversees control of product manufacturing operation areas including cleanrooms, component prep and sanitization, filling, and packaging activities
• Works closely with Validations, Facilities, Quality, Project Management and Senior Management to ensure the needs of all functions are met
• 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.

• Ability to stand, sit or remain in the same position for extended periods of time
• May be required to travel between sites
• Follow written instructions
• Able to train others
• 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.

• Proficiency in pharmaceutical process development for aseptically produced products or medical device manufacture
• Working knowledge of pharmaceutical facilities, lyophilization technology and manufacturing equipment as well as cleanrooms
• Strong troubleshooting and root cause analysis skills
• Able to effectively lead and coordinate multiple, complex requests/projects and allocate resources effectively
• Able to effectively deal with complex technical issues using structured analysis, methodology and articulates clear and concise direction to other operations staff
• Excellent oral and written (reports) communication skills
• Strong organization and leadership skills
• Self-motivated with a drive for excellence; able to inspire and motivate