Operational Excellence Specialist

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.

CordenPharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people s lives.

Our network in Europe and the U.S. offers flexible and specialized solutions across five technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.

SUMMARY

The Operational Excellence Specialist is responsible for working with the Associate Director of Operational Excellence to drive the success of the overall Operational Excellence Program.

The individual is accountable for supporting operational excellence projects, gathering data to help prioritize work, and make recommendations for upcoming projects and improvement areas. The OE Specialist monitors project performance 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 potential execution of small projects.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• Maintain a customer (internal and external) focus and push for innovative improvements while balancing and assessing risks without compromising legal or safety
• Investigate and translate ideas into business cases, projects, and action plans. Support in setting realistic milestones, support and monitor execution, anticipate delays and roadblocks, and escalate when needed
• Gather data and metrics for ongoing or completed projects; and report monthly metrics for projects and other OE Programs
• Measure potential and actual savings for identified projects and verify savings as projects progress
• Support ongoing or new Green Belt or Black Belt Projects, both in labs/development and production
• Gather and organize information to give regular updates to stakeholders, as well as give recommendations for potential projects or future improvements
• Help drive ongoing efforts for 6S, OEE, Lean Labs, and Visual Factory, including data collection, training support, and administrative tasks
• Understands performance indicators (leading, lagging, process, and key) and how they work together to drive sustainable improvement
• Improves the culture and competencies related to efficiency and continuous improvement within the company with OE methodologies
• Help teams to understand, learn, and use L6S tools and techniques for current and future purposes
• Build positive rapport with all departments and gather feedback on potential project ideas and pain points, as well as help deliver clear vision of the OE efforts on site
• Display continuously the characteristics of a Change Leader in the organization in order to motivate colleagues to participate in Excellence Programs by leading by example and bringing in success stories
• Use understanding of projects, data, site goals, and OE Programs to make recommendations for improvements and areas of focus to Leadership Team and stakeholders

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.

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

Two years of Production experience or equivalent. Three continuous improvement accomplishments or equivalent. GMP experience desired and CDMO experience is a plus. Knowledge and experience with statistical analysis and financial analysis,

Lean Six Sigma Black Belt, or Green Belt certification 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

None.

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 (work 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.

• 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 Maternity/Paternity Leave
• Tuition Reimbursement
• Wellness Program
• Vacation Three Weeks 1st Year

This Post will Expire on October 5, 2024