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Manufacturing Operations Manager

Location : Mahwah NJ US 07430
Job Type : Direct
Reference Code : 20534-AB1
Compensation : 100000.00 - 120000.00 USD/YEAR
Start Date : 04/16/2021
Hours : Full Time
Required Years of Experience : 5
Required Education : BS Engineering or Science
Travel : No
Relocation : No
Job Industry : Pharmaceutical

Job Description :

  • Permanent position for a Manufacturing Operations Manager responsible for efficient capacity utilization of site resources to meet customer demand by managing client projects to ensure delivery of results within project scope, agreed timelines, contract requirements, revenue targets, within budget, and in compliance with regulatory requirements.

  • Plan, schedule, manufacture and deliver clinical cell therapy products according to established procedures, regulations and contract by ensuring capacity availability of personnel, equipment, and other resources.

  • Close manufacturing documentation in a timely manner in accordance with applicable regulations and per contract.

  • Ensure performance of clinical manufacturing for clients per contract.

  • Ensures process hours are charged and tracked to meet contract and revenue targets.

  • Partner with clients, project management, and cross team leaders (supply chain, training, quality systems, and business development) to troubleshoot problems, suggest improvements and determine & advocate for value-add projects.

  • Hiring and supervising several manufacturing associates, trainers and compliance investigators, including Associate Manager.

  • Responsible for planning, assigning, and directing work, appraising performance, and resolving problems.

  • Ensure manufacturing space is kept in a clean, safe, and in a validated state in compliance with company procedures, GMP and applicable regulations.

  • Ensure department staff comply with corporate and site-specific HR policies, safety and business policies and practice.

  • Implement training programs and approve job specific curriculum and professional development for new associates and cross training of existing staff.

  • Determine team expectations, goals, KPIs, ROI targets and business direction.

  • Develop, track and maintain metrics monthly.

  • Coordinate team meetings in manufacturing unit and determine strategy development and drive continuous improvement.

Required Qualifications :

  • BS Life Science or Engineering

  • Minimum 5 years of manufacturing leadership experience in a cGMP environment for aseptic processing and cell processing.

  • Experience with continuous improvement for manufacturing.

  • Deep understanding of cGMP and cGLP with accountability and strong dedication to regulatory compliance.

  • Strong business acumen with integrity and knowledge of financial operations and budget development.

  • Detail oriented, strategic thinker with strong analytical, problem-solving, multitasking, and written and oral communication skills.

  • Strong collaborative, leadership, and influencing skills with the ability to work well in a cross-functional, matrixed environment.

  • Flexible and able to work during a weekend and adapt to evolving responsibilities.

  • Experience with Visio, Microsoft Project and Excel.

  • Ability to lift and/or move up to 30 pounds.

  • Ability to wear PPE when handling human specimens, gases, corrosive chemicals, and liquid nitrogen.

  • Ability to handle moderate noise conditions.

Contact: Allan Berman

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