Sr. Operational Excellence Specialist

About the Role

CordenPharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical and biotech companies manufacture medicines with the ultimate goal of improving people’s lives. Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms: Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides.

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. This role monitors project performance through business impact and reports on progress as well as potential roadblocks and issues. The Sr. OE Specialist adopts Lean Manufacturing and Six Sigma methodologies and applies strong change management and influence skills to meet defined business objectives, supporting both ongoing and site-wide projects.

Responsibilities

• 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.
• 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 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.
• 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) manufactures a variety of pharmaceutical products in accordance with Current Good Manufacturing Practices (cGMP), US Food and Drug Administration (FDA), and International Council for Harmonisation Q7 (ICH) regulations. Adherence to clearly defined procedures, in compliance with cGMP principles, is required when performing operations. All staff must participate in and commit to the Quality Management System to ensure products are consistently produced to accurate quality standards.

Requirements

• 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; CDMO experience is a plus.

Skills

• Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals.
• Ability to write reports and correspondence, lead or contribute to meetings, and work effectively with others.
• Ability to perform mathematical operations including addition, subtraction, multiplication, division, computation of rate, ratio, percent, and interpretation of bar graphs.
• Advanced data analysis and statistical skills.
• 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.
• Advanced Microsoft Office Suite skills, particularly Excel for data analysis.
• Excellent verbal and written communication skills, including facilitating, presenting, and driving decision-making and organizational change.
• Working experience in Project Management including project team oversight, resource identification, budgets, scheduling, and planning.

Core Competencies

• 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, and project/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.

Physical Demands

• Ability to lift 25 lbs. occasionally.
• Ability to effectively utilize computer equipment.
• Required to wear personal protective equipment (PPE) such as hard hat, safety glasses, safety boots, uniform, respiratory protection, and chemical-resistant garments as necessary.
• Regularly required to climb stairs or ladders, stand, walk, work with hands, reach above shoulder height, climb or balance, talk or hear, and taste or smell.
• Occasionally required to sit, stoop, kneel, crouch, or crawl.
• Specific vision abilities required include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

Work Environment

• Regular exposure to office, laboratory, and manufacturing floor environments (working with potential potent APIs and intermediates, hazardous compounds, and solvents).
• Occasional exposure 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.
• Moderate noise level in the work environment.

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