Senior Director of Biomanufacturing - Fargo, ND

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Job Description

Position Summary:

Senior Director, Biomanufacturing has key responsibility and oversight for functions of the Manufacturing and Materials Management departments. Responsible for the manufacture of research grade, cGMP clinical and commercial products, ensuring all products are within the appropriate level of compliance meeting client expectations and delivered on schedule and budget. This position has a direct contribution to the development of business and/or functional strategies and responsibility for managing multiple teams of professionals at the site. The Sr. Director of Biomanufacturing is to assure that the company stays on schedule, meeting the demand/ revenue targets, and profitability measures that meet or exceed the goals set by executive management. The Sr. Director of Biomanufacturing must also ensure quality compliant, cost effective and collaborative operations of the manufacturing site.

Key Activities:

  • Responsible for meeting production goals while maintaining quality standards, management of cost, quality, and delivery.
  • Work with Manufacturing Directors to ensure the prioritization of production schedules based on project timelines, resource efficiency and materials supply.
  • Oversee, either directly or indirectly, Manufacturing and Materials Management investigations, CAPAs, process variances and deviations. Ensure that all Manufacturing and Materials Management owned change controls, CAPAs, and deviations are completed by the due date.
  • Responsible for maintaining a smooth flow of work between departments. Keeps priority on key metrics related to service levels, deviations/ CAPA, other operational efficiencies, inventory/ distribution metrics, capital / resource utilization and for resolving interdepartmental conflicts.
  • Balance manufacturing in-house and through third parties to maintain timelines and maximum efficiency.
  • Interface with clients to provide manufacturing updates, support technical discussions or onsite visits.
  • Build and maintain bridges between quality, operations and process development to ensure design concepts and specification requirements, best utilize equipment and manufacturing techniques and ensure product performance and regulatory requirements are translated to measurable and repeatable process outputs.
  • Accountable for operation costs and budgets, efficiency, productivity, continuous improvements, all measured through various metrics including yields, throughput efficiencies, labor and materials.
  • Participate and/or lead in the planning and coordination of production changes, product line extensions, or new product launches to ensure orderly and timely transitions in material or production flow.
  • Confers with managers in establishment of shift standards and working schedules for all departments to meet organizational needs and project timelines.
  • Proactively resolves technical or operational issues.
  • Analyze costs and provide support for the pricing methodology to ensure profitability in product/project pricing of the various service programs.
  • Identify alternate raw materials with equivalent performance to optimize cost and/or supply efficiency.
  • Develop relationships with, and communicate regularly, with raw material suppliers to discuss specifications, sourcing, and new product options
  • Ensure and coordinate sustained supply of all raw materials and establish anticipated growth rates for all raw materials.
  • Collaboratively lead with Process Development in transferring new products/processes to ensure seamless implementation of new product technology into clinical or commercial manufacturing through process engineering activities resulting in a well-defined and documented manufacturing processes.
  • Develop, implement and monitor departmental objectives and schedules including setting priorities and performance expectations while ensuring alignment with expected deliverables, site metrics and company goals.
  • Assist in the development of validation plans and supervise the execution of validation/verification activities occurring in operations, including validation of process and instrument/equipment.
  • Participate with Managers, Directors and Executives to establish strategic plans and objectives for Manufacturing and Materials Management.
  • Develop and implement metrics to track and manage successful, timely accomplishment of assigned goals, objectives and projects that are in alignment with the goals set by executive management.
  • Create strategic plans for process and plant improvements to increase efficiency and drive down costs.
  • Work closely with peers and counterparts at other sites and across functions to drive manufacturing excellence, share best practices and lessons learned to create industry-leading manufacturing processes and products.
  • Ensure facility is maintained in a constant state of inspection readiness and compliant with the various regulatory agencies such as the FDA, EMA and compliance with EHS programs and practices, including that all staff are compliant with cGMP and all related elements such as facilities, documentation (SOPs and validation protocols etc.), training, reports and records.
  • Provide leadership and direction in representing the site during agency and client inspections and formulation of inspection responses.
  • Communicate operational status to senior management regularly and at the appropriate level of detail. Communications will be both written documents, and in formal and informal oral presentations.
  • All employees are responsible for the general upkeep of work and shared spaces.
  • Other duties as assigned.     
Required Qualifications:
  • Bachelor’s degree required in life science or engineering, graduate degree preferred.
  • Experience producing phase III and/or commercial products is required.
  • Minimum of 15 years of experience in Manufacturing operations in a biotechnology or pharmaceutical manufacturing organization.
  • Minimum of 7 years of experience in direct management of Manufacturing operations in a biotechnology or pharmaceutical manufacturing organization.
  • Experience working for or with a contract manufacturing organization is preferred.
  • Demonstrated experience leading commercial cGMP pharmaceutical manufacturing operations.
  • Experience leading cross functional teams with direct experience leading an independent manufacturing site preferred.
  • Experience in new site construction and establishment of new operations organization highly desirable.
  • Experience in root cause investigations and successful implementation of corrective actions and countermeasures
  • Experience bringing new products from development to full commercialization.

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Posted: Apr 30, 2018

Type: Full Time

Category: Operations Pharmaceuticals Manufacturing Director GMP FDA