Manager, Manufacturing Support

Role Summary

The Manufacturing Support Manager develops, organizes, and executes the implementation of the Critical Environment Cleaning Program across the business. This position will also be responsible for the scheduling of manufacturing production activities and supporting the daily Tier processes.

Responsibilities

• Participates in internal and external strategy and planning meetings, surveys, new business presentations, mobilization, and support activities related to the Critical Environment Cleaning Program.
• First line of contact to all facilities cleaning, GMP & Non- GMP cleaning.
• Serve as back up for administration of Tier 2 meetings and attendance at Tier 3 meetings for Manufacturing.
• Manage the scheduling process of manufacturing activities and serve as back-up finite scheduler.
• Act as project lead for manufacturing support projects.
• Provides metrics for manufacturing schedule adherence.
• Ensure site cleaning and gowning programs in compliance with Novartis Standards to maintain site in compliant state for GMP manufacturing of gene therapy products.
• Develops and maintains compliant housekeeping program to ensure GMP manufacturing and testing facility is in compliant inspection ready state. Programs to include routine walkthrough of GMP warehouse, manufacturing, and test labs, to identify, track and resolve housekeeping deficiencies.
• Manages budget and staffing levels to ensure appropriate resources available for both FTE and external service providers.
• Approves vendor invoices as needed and assist in developing and approving necessary service contracts.
• Manages inventory levels for both cleaning and gowning materials as well as supplier contracts or service contracts associated.
• Reviews and evaluates existing cleaning programs, services, makes recommendations to operations team and/or client.
• Maintains compliant procedures and logbooks associated with activities.
• Supports investigations related to cleaning, gowning, or housekeeping.
• Authors CAPAs, Quality Events, CR Actions, and other Quality non-conformances.
• Partners with Quality to address these issues effectively and compliantly.
• Coordinates daily operations with scheduling team to ensure cleaning activities align with manufacture and testing operations.
• Develop and report appropriate KPI for cleaning, gowning and housekeeping.
• Identifies and implements continuous improvement opportunities.
• Leads and mentor staff.
• Writes performance reviews and annual goals, holds one-on-ones, and handle HR related matters Implement, train, and educate staff on the on-going efficient delivery, operation, and maintenance of the cleaning program.
• Other related duties as assigned.

Qualifications

• Essential: Bachelors' Degree in a scientific, engineering, or business related field with 5+ years of experience in biopharmaceutical industry or 7+ years relevant industry experience in lieu of degree.
• Solid knowledge of FDA regulations and GMP systems.
• Excellent oral and written communication skills.
• Demonstrated leadership skills.
• Experience managing contract employees or service providers, preferably in a GMP environment.
• Experience and working knowledge of GxP, and/or ISO safety cleaning standards.
• The ability to read, comprehend, and transmit complicated detailed instructions in writing and orally required.
• Knowledge of the Business and Industry marketplace, current Good Manufacturing Practice (cGMP) and other critical environment cleaning practices and procedures, applicable laws, health, safety and environmental practices, principles of management and supervision, and department procedures and policies.

Education

• As listed in Qualifications above.

Additional Requirements

• Location: This position will be located in Durham, NJ and will be a full time On-Site position. Relocation support not provided.