Senior Manager Business Operations Lead

3 days ago

Summit, New Jersey, United States Caliber Sourcing Full time
Job Title: Senior Manager, Business Operations Lead

Join Caliber Sourcing in a role that will challenge you to grow and thrive in a dynamic environment. As a Senior Manager, Business Operations Lead, you will be responsible for overseeing the performance management and scheduling of all processes associated with MSS operations.

Key Responsibilities:
  • Drive timely, compliant, and efficient completion of production tasks for Cell Therapy products to support product Value Stream outputs according to Current Good Manufacturing Practices (cGMP's).
  • Take personal responsibility to work safely and drive accountability and process for team members to do the same.
  • Accountable for the Process Documentation produced by the team.
  • Understand Cell Therapy production steps and sequence for each Unit Operation, role model good execution and behaviors for team members.
  • Responsible for providing the Production Scheduling team with information on the availability production resources and task execution/progression.
  • Actively define team priorities and adjust as necessary to align with site and or functional priorities.
  • Drive completion, adherence to training requirements, and assess appropriate level of training for team members.
  • Building of a high-performing team and help recruit exceptional people.
  • Conduct regular 1:1 meetings/skip levels with team members to mentor, develop/motivate individuals.
  • Lead troubleshooting activities for the team and provide ownership of Deviations occurring in area.
  • Build trust and productive relationships with peers and stakeholders while driving collaboration across the company and external partners.
  • Define strategic projects, change controls, and CAPAs as required to restore area performance and ensure optimal compliance levels.
  • Effectively control expenses within their influence.
  • Lead by example, role model leadership behaviors, and drives their team to adhere to the Caliber Sourcing values of Inclusion, Accountability, Innovation, Urgency, and Passion.
Requirements:
  • Advanced knowledge of cGMP/GDP/Pharmaceutical regulations and applications.
  • Advanced knowledge of cryopreservation, material handling, and logistics including best industry practices, application of principles, concepts, practices, standards, validation, and qualification.
  • Strong knowledge and application of OSHA, DEA, USP, and other applicable WH regulations.
  • Proficiency in ERP systems/WMS Applications, Scheduling, and analytics tools.
  • Proficiency in system and application use for business operations.
  • Proficiency in MS Office applications.
  • Proficiency in analytical, problem-solving, critical thinking skills, and strong situational decision-making.
  • Proficient organizational and time management skills.
  • Strong written and verbal communication skills.
  • Intermediate presentation development and delivery skills.
  • Ability to adapt to changing business conditions while maintaining appropriate level of controls and compliance with regulatory requirements.
  • Ability to travel 15% of time.
Working Conditions:
  • Intermittent walking and sitting to perform job functions.
  • Physical dexterity to effectively use computers and documentation.
  • Vision and hearing capability to work in job environment.
  • Lift maximum of 25 pounds.
  • Ability to work around laboratories and controlled, enclosed, restricted areas.
  • Wear required cleanroom garments and personal protective equipment in designated areas.
  • Makeup, gum, nail polish, or other potential microbial sources are prohibited in restricted areas.
  • Exposure to reagents, chemicals, exposure to sanitization agents are expected, and potential exposure to human blood components.
  • Areas may prohibit food, any outside materials, cell phones, and tablets.

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