PCI Services-posted 2 months ago
Bedford, NH
Professional, Scientific, and Technical Services

The Manager, Pharmaceutical Operations 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.

  • 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
  • BA science degree, or equivalent
  • A minimum of 5 years relevant pharmaceutical or medical device manufacturing experience
  • Proven aseptic process leadership experience
  • 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.
  • Understanding of basic contamination and aseptic technique and any formal training would be beneficial.
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