Plant Supervisor - Sterling Drive C Shift bei Corden Pharma Colorado
Corden Pharma Colorado · Boulder, Vereinigte Staaten Von Amerika · Onsite
- Professional
- Optionales Büro in Boulder
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
Supervises a crew consisting of Operations Chemists & Operators and monitors plant activities to meet production requirements. Supervision areas may include commercial manufacturing, developmental processing, and high potent compound manufacturing as assigned by the Plant Manager. Directs activities in a manufacturing environment to meet all safety, quality, and productivity goals established by the company.
Responsible for production of products on time, in full, and at the right quality, ensuring both plant and lab process activities stay within established guidelines. Strives to continuously improve manufacturing, development, and high potent business processes, such as changeovers.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Include the following. Other duties may be assigned.
- Member of the Emergency Brigade, functioning minimally at an Assistant Brigade Chief level
- Organizes and schedules work; supervises daily operations of small-scale and potent labs
- Coordinates with other departments, including Quality, R&D, Technical Teams, Supply Chain, and Warehouse, as needed, to maintain production schedule
- Leads teams to meet safety, quality, and production goals for potent compound APIs and intermediates
- Motivates, trains, coaches, develops, and evaluates operator performance
- Ensures compliance with safety, IH, environmental, GMP, housekeeping, and work practice SOPs
- Coordinates equipment availability and work with Operations Specialist to ensure that equipment is cleaned and ready for use
- Works with Plant Managers to ensure all aspects of campaign preparation are on track for the agreed upon campaign start date
- Interviews and hires employees
- Organizes and directs the work of contractors and maintenance workers as appropriate
- Drives process and physical change control activities
- Supports and/or leads quality (deviation), business efficiency (yield, etc.), and investigations related to area processes
- Identifies and improves deficiencies in safety, quality, and productivity
- Ensures high standards for documentation for all manufacturing and developmental activities
LEADERSHIP & BUDGET RESPONSIBILITIES
Directly supervises 5 to 15 employees. Oversees maintenance and contractor activities within the assigned area of responsibility. Executes leadership responsibilities in accordance with Corden policies and applicable laws.
Supervisory responsibilities include daily leadership of team; training and development; interviewing & hiring; managing time & attendance records; performance appraisals; rewarding & discipling employees; and resolving daily problems & conflicts as they arise.
SAFETY & ENVIRONMENTAL RESPONSIBILITIES
Every individual is personally responsible for the safety and environmental aspects of his or her 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 accommodation may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE
High School Diploma or General Education Degree (GED) and 5 years related experience and/or training in a Manufacturing or Developmental environment. Experience with laboratory small scale-based manufacturing is a plus as is experience in highly potent compound manufacturing; or equivalent combination of education and experience with Small-Scale Chemistry Operations. College degree in Chemistry or Chemical Engineering, while not required, is beneficial.
LANGUAGE SKILLS
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively to groups of employees or visitors.
MATHEMATICAL SKILLS
Ability to apply basic concepts of arithmetic, algebra, and geometry. Ability to calculate figures and amounts such as raw material charges, unit conversions, proportions, percentages, area, circumference, and volume.
REASONING ABILITY
Ability to apply common sense to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several abstract concepts in unique 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 is regularly required to talk or hear. The employee frequently is required to stand, walk, and sit. The employee is occasionally required to work with hands; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
May require shiftwork (12 hours) and occasional nights, weekends, or holidays.
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 occasionally exposed to fumes or airborne particles and low levels of toxic or caustic chemicals, moving mechanical parts, outside weather conditions, and risk of electrical shock. 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.
- Demonstrated understanding and experience In Chemical Processing, chemical process equipment, process scale up, and cGMP operations
- Leadership and delegation skills
- Strong math skills
- Strong reading comprehension
- Demonstrated mechanical aptitude & troubleshooting abilities
- Demonstrated training and facilitation skills
- Excellent written and verbal communication skills
- Ability to interact with supporting groups including technical team, project management, SHE, engineering, and maintenance teams.
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 Paternal 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 12/01/2025