Plant Supervisor

Corden Pharma 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.

We are a 24/7 manufacturing operation. The Plant Supervisor shift may be days or nights based on business needs.

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…