Job Description

Job Description

Job Description

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

Manage resources and cross-functional efforts to successfully achieve customer deliverables and project objectives for contracted development and technical transfer of active pharmaceutical ingredients at Corden Pharma. Additionally, provide leadership and mentoring to other Project Managers as assigned.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

Project Manager for New Product Introduction

• Drive adherence to Corden’s contractual commitments: develop project plan including resources, timing, milestones, and deliverables. Track, monitor, and report key performance metrics including expenditures vs. budget
• Manage and control multiple projects to meet objectives
• Act as a liaison between Corden Pharma and customer project manager to ensure mutual agreement of contract scope and schedule
• Monitor trends and drive continuous improvement of the project management process
• Develop and distribute periodic reports on project performance, issues, risks, and schedules of key activities, events, or milestones
• Identify, escalate, and facilitate resolution of manufacturing, supply chain, or quality issues that may adversely affect project performance goal
• Ensure risk assessments and appropriate risk mitigation plans are established for projects at every phase of the contract
• Collaborate with R&D, Quality, and Operations to understand critical to quality product requirements
• Lead and coordinate the preparation of Proposals for New Business RFPs. Lead preparation of Proposals for scope additions to existing Development Projects

Project Manager Leadership and Mentoring

• As needed, provide leadership and mentoring to two to three Project Managers
• Provide guidance regarding business processes, communication, issue resolution, and other key topics to assigned Project Managers
• Act as a sounding board and provide feedback to assigned Project Managers
• Assist in the onboarding and professional development activities. Work with the Director of PMO to provide development paths
• Provide technical judgment, bringing together stake holders and subject matter experts as needed to generate change and facilitate problem resolution

LEADERSHIP & BUDGET RESPONSIBILITIES

Provides guidance and leadership where appropriate. Participates in the expense budget process by developing, tracking, and reporting data related to teams and projects.

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, Chemical Engineering, or other technical degree. Ten (10) years’ experience in Pharma Industry, with 5 years in Project Management and external customer communications, and 5 years of demonstrated success in in an API Development and Manufacturing environment, or equivalent combination of education and experience in API Development and Manufacturing environment.

LANGUAGE SKILLS

Ability to read, analyze, and interpret common scientific and technical journals, financial reports, political and legal documents. Ability to effectively present information to top management, public groups, and/or board of directors.

MATHEMATICAL SKILLS

Ability to work with mathematical concepts such as probability and statistical inference, and fundamentals of plane and solid geometry and trigonometry. Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.

REASONING ABILITY

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form, and deal with several abstract and concrete variables.

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 sit; work with hands; and talk or hear. The employee is occasionally required to stand; walk; 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 25 pounds. Specific vision abilities required by this job include 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 and noise typical of an office environment.

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.

• Working knowledge of Biotech/Pharma Manufacturing operations, Product and Process Development, and Supply Chain Operations in a cGMP-regulated environment
• Demonstrated outstanding customer service skills
• Excellent verbal, written, and interpersonal communication skills
• Good business negotiation skills
• Excellent leadership and influencing skills in diverse team environment
• Excellent organizational skills. Capable of handling multiple tasks/projects
• PC skills to include MS Project, Excel, and Word
• Technical understanding of Organic Chemistry
• Broad, demonstrated expertise in Chemical Engineering and API Process Improvement
• Thorough, demonstrated knowledge of pilot through manufacturing scale unit operations, scale-up, and plant design considerations

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 on October 3, 2025

Job Tags

Contract work, Work at office, Local area, Worldwide, Flexible hours,

Similar Jobs