The Sr. Operational Excellence Specialist is responsible for working with the Associate Director of Operational Excellence and the Operational Excellence Team to drive the success of the overall Operational Excellence Program.
The individual is accountable for identifying Operational Excellence projects, prioritizing opportunities based on business impact, and making decisions for upcoming projects and improvement areas. The Sr. OE Specialist monitors project performance through business impact and reports on progress as well as potential roadblocks and issues.
This role is responsible for adopting the appropriate Lean Manufacturing and Six Sigma methodologies and application of strong change management, and influence skills to meet defined business objectives. The position is also accountable for supporting ongoing projects as well as execution of site-wide projects.
Key Skills for This Role
Microsoft Office SuitePPELean Six SigmaSix SigmaLean Manufacturing6S
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SUMMARY
The Sr. Operational Excellence Specialist is responsible for working with the Associate Director of Operational Excellence and the Operational Excellence Team to drive the success of the overall Operational Excellence Program.
The individual is accountable for identifying Operational Excellence projects, prioritizing opportunities based on business impact, and making decisions for upcoming projects and improvement areas. The Sr. OE Specialist monitors project performance through business impact and reports on progress as well as potential roadblocks and issues.
This role is responsible for adopting the appropriate Lean Manufacturing and Six Sigma methodologies and application of strong change management, and influence skills to meet defined business objectives. The position is also accountable for supporting ongoing projects as well as execution of site-wide projects.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Include the following. Other duties may be assigned.
Lead large-scale, cross-functional, and value stream-level Operational Excellence initiatives that deliver substantial and sustainable improvements in safety, quality, delivery, cost, and customer satisfaction
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Partner with value stream leadership and site leaders to identify, prioritize, and develop improvement roadmaps aligned with operational objectives and strategic goals
Maintain a customer-focused mindset and identify innovative improvement opportunities while ensuring compliance with safety, quality, regulatory, and business requirements
Translate business challenges into improvement portfolios, business cases, and execution plans, ensuring resources and efforts are focused on the highest-value opportunities
Drive performance management systems by establishing, analyzing, and improving leading, lagging, process, and key performance indicators that support sustainable business results.
Validate and communicate operational and financial benefits of improvement initiatives, partnering with business leaders to ensure realization and sustainability of results
Measure and track project benefits, including productivity, cycle time, quality, capacity, and cost savings, and support validation of results
Facilitate Kaizen events, process mapping workshops, root cause analyses, and other continuous improvement activities within departments or functional areas
Direct and continuously improve site Operational Excellence programs including 6S, OEE, Lean Labs, Visual Factory, and Daily Management Systems to drive site-wide adoption and maturity
Lead and coach Green Belt and Black Belt projects across Manufacturing, Development, Quality, Supply Chain, and supporting functions
Serve as a site Subject Matter Expert in Lean Six Sigma methodologies, advanced problem-solving, value stream optimization, and continuous improvement best practices
Mentor leaders, managers, and Operational Excellence practitioners to strengthen organizational capability, accountability, and continuous improvement of culture
Influence decision-making at all levels of the organization by using project results, operational data, business priorities, and OE Program insights to recommend strategic improvement priorities to site leadership
Act as a change agent by promoting Operational Excellence principles, sharing success stories, and driving engagement in improvement initiatives
LEADERSHIP & BUDGET RESPONSIBILITIES
Indirect supervision through leadership and project management of site initiatives.
SAFETY & ENVIRONMENTAL RESPONSIBILITIES
Every individual is personally responsible for the safety and environmental aspects of their activities in the workplace. Each employee is expected to perform their job duties in a safe manner utilizing all their knowledge, training, ability, and experience.
QUALITY RESPONSIBILITIES
Corden Pharma Colorado (CPC) is a manufacturer of a variety of pharmaceutical products. In following Current Good Manufacturing Practices (cGMP), Corden Pharma Colorado manufactures in accordance with the US Food and Drug Administration (FDA), International Council for Harmonisation Q7 (ICH), and other global regulations as applicable. This is critical as it is our mission to not place patients at risk due to inadequate safety, quality, or efficacy. CPC’s Quality Management System, which incorporates cGMP, is designed to deliver this quality objective. Attainment is produced through the requisite participation and commitment of all staff across departments and at all levels within the company.
cGMP is the part of Quality Management System ensuring products are consistently produced to accurate quality standards. Adherence to clearly defined procedures, in compliance with the principles of cGMP, is required when performing operations across Corden Pharma Colorado.
QUALIFICATIONS
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
Bachelor’s Degree in a Science or Engineering field; or equivalent combination of education and experience. Ten years’ total professional experience in manufacturing, operations, engineering, quality, supply chain, laboratory operations, or pharmaceuticals. Five years of direct Operational Excellence, Lean, Six Sigma or Continuous Improvement Leadership experience. Black Belt certification and experience with statistical analysis is preferred. Knowledge and experience with financial analysis is preferred. GMP experience preferred and CDMO experience is a plus.
LANGUAGE SKILLS
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write reports and correspondence. Ability to lead or contribute to meetings and work effectively with others.
MATHEMATICAL SKILLS
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent and to draw and interpret bar graphs. Ability to handle advanced data analysis and statistics.
REASONING ABILITY
Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in complex situations.
CERTIFICATES, LICENSES, REGISTRATIONS
Black Belt certification preferred.
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee must have the ability to lift 25 lbs. occasionally and the ability to effectively utilize computer equipment.
The employee is required to physically inspect and oversee facilities/operations that may require use of personal protective equipment (PPE) and exposure to hazardous materials (hard hat, safety glasses, safety boots, and uniform). Required to wear full PPE (i.e., respiratory protection, chemical resistant garments, etc.) as necessary.
The employee is required to regularly climb stairs or ladders, to stand; walk; work with hands; climb or balance; talk or hear; and taste or smell. The employee frequently is required to reach above shoulder height. The employee is occasionally required to sit and stoop, kneel, crouch, or crawl. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
WORK ENVIRONMENT
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly exposed to an office, laboratory, and manufacturing floor (working with potential potent APIs and intermediates, hazardous compounds, and solvents).
The employee is occasionally exposed to wet and/or humid conditions; high, precarious places; uncomfortable extremes of temperature; fumes or airborne particles; low levels of toxic or caustic chemicals; outside weather conditions; and vibration. The noise level in the work environment is usually moderate.
CORE COMPETENCIES
These are the specific areas of knowledge, skill, and ability that are important for successful job performance. They must be job related and consistent with business necessity.
Strategic Continuous Improvement Leadership: Identifies, prioritizes, and leads value stream improvement initiatives that drive sustainable business performance
Continuous Improvement Execution: Applies Lean Six Sigma tools, structured problem-solving methodologies, as well as project and stakeholder management techniques to deliver measurable operational improvements
Coaching & Capability Development: Develops leaders, Green Belts, and teams by building continuous improvement skills, accountability, and problem-solving capabilities
Change Leadership & Development: Drives organizational adoption of improvement initiatives and influences leaders at all levels to achieve desired outcomes
Business and Financial Acumen: Links operational improvements to business priorities, financial impact, capacity, productivity, and customer outcomes
Knowledge of Six Sigma and Lean Methodology
Advanced Microsoft Office Suite skills. Manipulation of Excel for data analysis
Excellent verbal and written communication skills; including facilitating and presenting, and driving decision making & organizational change
Working experience in Project Management including project team oversight, resource identification, budgets, scheduling, and planning required
SALARY
Actual pay will be based on your skills and experience.
BENEFITS
401(k) matching - Corden Pharma will contribute 100% of the first 6% - 100% vested after 2 years of service
Accident Plan
Critical Illness Insurance
Dental Insurance
Disability Insurance
Employee Assistance Program
Flexible Spending Account
Health Insurance PPO/HSA
Hospital Indemnity Plan
ID Theft Protection
Life Insurance
Paid Parental Leave
Tuition Reimbursement
Wellness Program
Vacation – Three Weeks 1st Year
Vision Insurance
EQUAL OPPORTUNITY EMPLOYER
Corden Pharma provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state, or local laws. Corden Pharma embraces fair hiring practices.
