Sr. Operational Excellence Specialist

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. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.

Our People Vision

We strive for excellence. We share our passion. Together, we make a difference in patients' lives.

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.

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.

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.

This post will expire September, 18, 2026