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Corden Pharma - A Full-Service CDMO

Plant Manager

Corden Pharma - A Full-Service CDMO, Boulder, Colorado, United States, 80301

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Corden Pharma - A Full-Service CDMO provided pay range This range is provided by Corden Pharma - A Full-Service CDMO. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range $160,000.00/yr - $220,000.00/yr

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 Plant Manager has oversight and ownership of all activities in their assigned production areas to ensure production targets are met while maintaining safety and compliance. Provides day-to-day management and leadership of assigned production areas as well as leads long term improvements and proactive efforts to help meet site goals.

Ensures production schedule adherence, implements process improvements, meets budget, ensures personnel are appropriately trained and motivated, and regulatory compliance is maintained in Quality, Safety, Health, & Environment (SHE), and Human Resource areas. Represents Operations on project teams, audits, and customer visits. Provides overall production leadership on the Corden Pharma site in conjunction with the Operations Director.

Essential Duties And Responsibilities

Plans and manages production activities and establishes production priorities to ensure schedule adherence and right first time, product quality, on-time deliveries, regulatory compliance, and plant and process optimization

Knowledge of and ability to manage APIs, including the associated safety, containment, and special operational techniques associated with high potent and peptide API production

Works with Site Leadership to determine plant capacity, identifies improvements, and establishes budgets and sets goals to align with site and company goals

Revises production schedules and priorities to meet changing business conditions and ensure plant optimization through working with process engineering, maintenance, and other departments

Reviews production and operating data and resolves operational, process, equipment, and maintenance problems to ensure cost minimization and prevention of operational delays. Leads investigation into discrete events determining and implementing resulting CAPAs

Develops and implements standardized operational, work and safety practices for area of responsibility to ensure a minimum of incidents, deviations, and injuries

Develops annual operating budget for approval and manages and maintains assigned functional area within budget targets

Works with Operational Excellence and MSAT to reduce COGS and proactively implement improvements to increase plant throughput and reduce compliance and safety risks

Leads hiring, talent management, and retention efforts with all operations staff. Investigates and resolves employee issues and complaints in area of responsibility

Provides ownership and oversight of all new processes that are implemented on the floor and ensures execution of new development projects as well as commercial processing

Reviews all documents for execution of production activities and provides feedback and coaching for engineers, chemists, and other technical teams to drive RFT and efficiency

Provides leadership in conjunction with the Operations Director on driving initiatives to meet production goals and continue to improve production systems. Establishes and maintains strong, effective day-to-day working relationships between production, internal support, and regulatory functions

Implements and maintains adherence to all company policies concerning Safety, Health & Environment (SHE), Quality, and Human Resources

Interfaces with external customers through compliance audits, client tours, and works with technical teams to resolve customer issues

Leadership & Budget Responsibilities Manages operational staff and directs activities of technical staff in the commercial manufacturing areas and in Small Scale. Responsible for developing, controlling, and adhering to budget targets. Substantial input into the capital spending budget and vision for assigned area. Provides routine input into standard cost structure for products.

Supervisory responsibilities include daily leadership of team; training and development; interviewing and hiring; managing time and attendance records; performance appraisals; rewarding and disciplining employees; and resolving daily problems and conflicts.

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 accommodations may be made to enable individuals with disabilities to perform the essential functions.

EDUCATION And/or EXPERIENCE A BS in Chemistry or Chemical Engineering; a non-technical degree with applicable experience in a Manufacturing/Production environment may be considered equivalent. Ten years’ experience in a Pharmaceutical or Fine Chemicals Manufacturing environment, with an appropriate combination of technical and/or operational management assignments.

Language Skills Ability to read, analyze, and interpret common scientific and technical journals, financial reports, and legal documents. Ability to respond to common inquiries or complaints from customers, regulatory agencies, or members of the business community. Ability to write technical reports and instructions. Ability to effectively present information to management and groups of employees. Ability to present verbal instructions and explanations on technical and business issues.

Mathematical Skills Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to tasks such as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, factor analysis, etc.

REASONING ABILITY Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.

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 frequently required to stand, sit, and talk or hear. The employee is occasionally required to walk; work with hands; reach above shoulder height; climb or balance; stoop, kneel, crouch, or crawl; and taste or smell. Specific vision abilities required by this job include close vision, distance 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 occasionally exposed to moving mechanical parts, 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

Demonstrated expertise in chemical operations management

Ability to influence, manage, and direct capital and/or expense projects

Planning, implementation, and follow-up skills

Analytical problem-solving skills

Working knowledge of regulatory compliance issues in pharmaceutical manufacturing

Leadership and negotiation skills

Ability to build relationships and influence and motivate others

Facilitation skills

Coaching and mentoring skills

Written and oral communication skills and presentation skills

Ability to achieve results through the positive direction of others

Ability to positively and proactively, interact with other Corden sites as well as all external customers

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 posting will expire on November 24, 2025

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