Site Operational Excellence Lead

Cell and Gene Therapy

$90K — $120K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in engineering or related field, or equivalent experience.
  • Experience in the medical or biopharmaceutical industry is essential.
  • Proficient in MS Office, particularly Excel.
  • Strong analytical, organizational, and communication skills.
  • Ability to work independently and as part of a cross-functional team.
  • Results-oriented with a focus on achieving tangible outcomes.
  • Familiar with ISO 13485, FDA guidelines, and preferably Six Sigma (Green/Black Belt).

Responsibilities

  • Identify and prioritize business process improvements to achieve organizational goals.
  • Lead and support continuous improvement culture and provide necessary training and mentorship.
  • Implement a site Continuous Improvement program with a focus on lean methodologies and best practices.
  • Analyze operational performance metrics and provide improvement recommendations.
  • Develop and drive site action plans for performance enhancements in collaboration with leadership.
  • Participate in global Operational Excellence meetings to standardize best practices.
  • Meet with stakeholders to align resources and identify departmental constraints.,

Benefits

  • Opportunity to work closely with site leadership on key initiatives.
  • Access to training and mentorship in continuous improvement practices.
  • Exposure to global Operational Excellence networks and methodologies.
  • Involvement in significant cost-saving projects and initiatives.
  • Participation in a supportive culture of continuous improvement.
Full Job Description
What we are looking for:

The Site Operational Excellence Lead identifies, plans, and executes performance improvement activities across the facility and in alignment with organizational strategic goals and objectives. Through the implementation of lean methodology and other best practices, you will champion a culture of continuous improvement by empowering others to seek better ways of working. This role will work closely with Site leadership team members to enhance production capabilities, improve quality,reduce costs, and achieve customer service goals.

What you will do:
  • Identifies and prioritizes business process improvements and critical initiatives required to achieve both short-term and longer-term organizational goals - Annual Objectives (AOs) and Break Through Objectives (BTOs).
  • Leads and supports a culture of Continuous Improvement across the site and provide training and mentorship as needed in support of Operational Excellence initiatives.
  • Provides and implements a Site Continuous Improvement program in coordination with global organizational support, inclusive of training and execution around Lean, 5S, VSM/PFMs, Root Cause Analysis, and other "best practices" CI tools and methodologies.
  • Analyzes existing operational performance metrics such as run-rates, waste, capacity, and yields and provide recommendations for improvement opportunities.
  • Develops and drives Site action plans pertaining to performance improvements and establishes Manufacturing Tier Meetings with Site leadership team members.
  • Participate in global Operational Excellence and network team meetings to collaborate and ensure standardization of best practices and alignment on organizational activities.
  • Meets with key stakeholders as required to ensure proper resourcing alignment, prioritization, constraints identification, etc. on departmental activities.
  • Establishes Site Key Performance Indicators (KPIs) with local leadership to ensure performance targets are communicated and transparent throughout the facility.
  • Identifies top opportunities for Cost Savings and helps prioritize best allocation of resources to execute and realize these savings for leadership review.
  • Leads Continuous Improvement events such as Kaizens, Tiger Teams, and/or CI Projects as necessary to elevate business productivity and provide team members with structured support and tools to resolve issues/opportunities.
  • Conducts operational reviews and audits.
  • Identifies staffing requirements, participates in selection and hiring process, interviews applicants, and makes hire recommendations.

Who you are:
  • Minimum bachelor's degree in engineering or a related discipline, or equivalent combination of education and hands-on experience.
  • Experience with medical or bio pharmaceutical industry required.
  • Proficient computer skills using MS office, Excel,
  • Strong analytical, organizational and communication skills.
  • Both independent self-starting work habits and as a cross-functional team member.
  • Results Oriented: Being persistent and showing perseverance in achieving concrete and tangible results out of personal responsibility; getting optimum results from situations and being ready to act and show drive in case of obstacles or resistance.
  • Experience with ISO 13485 and FDA guidelines.
  • Six-sigma training a plus (Green Belt and/or Black Belt)
  • Ability to effectively communicate with coworkers and management. Business communication is conducted in English.
  • Familiarity with an ERP system and Quality Management System (eQMS) preferred.


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