- Senior
- Office 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
Provides strategic leadership and management for the Research and Development (R&D) Department. Responsibilities include setting and achieving objectives consistent with site strategy, developing and monitoring plans to meet departmental objectives, building employee capabilities consistent with site needs, and continuous improvement.
Provides R&D leadership to drive high performing teams, effective cross-collaboration with other departments, and to inspire confidence in the site’s technical scientific capabilities.
The R&D Department is responsible for the development of analytical methods and production processes for our client program portfolio. The Head of Development ensures that standard work and tactical plans for R&D activities are developed and results are achieved, consistent with customer expectations and site objectives.
Additionally, the Head of Development will support plant operations that could include troubleshooting and identifying substantial process improvements.
Drive best practices across the worldwide Corden R&D network through active participation across site R&D strategy and plan.
Member of the organization’s Leadership Team responsible for sustainable profitable growth.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Include the following. Other duties may be assigned.
- Responsible for R&D’s project portfolio. Ensures R&D meets customer expectations on budget and on time for the technical aspect of the projects, including route evaluation, process development, analytical development, and process characterization
- Responsible for technical evaluation of new projects, including identification of risks, innovation opportunities, capabilities needed, cost analysis, and pricing strategy. Provide written and verbal communication to customers to ensure confidence in ability to deliver on projects
- Ensure R&D capabilities align with strategic goals and provide competitive advantage. Ensure the proper technical resources and skills are in place and appropriately applied to meet and exceed R&D goals. Provide access to external technical sources and contacts, as needed to assure leading state of science and technology
- Identify technical, business, and interpersonal skill development needs of the members of the management team; and recommend appropriate training, either formal or on the job, and ensure training is effective
- Responsible for ensuring compliance with GMP, regulatory, safety, and environmental regulations and laws for local, state, and federal
LEADERSHIP & BUDGET RESPONSIBILITIES
Provides direct leadership to functional managers and their direct reports. Carries out leadership responsibilities in accordance with the policies and applicable laws.
Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; and addressing complaints and resolving problems.
Responsible for developing the budgets for the R&D Department and ensuring expenses are within the budgets.
Contributes to the direction and oversight of the operational aspects of the organization by serving on the site’s Leadership Team.
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
Doctoral Degree (PhD) or equivalent in Chemistry, Engineering, or related field with 15 years of experience; or equivalent combination of education and experience, within the Chemical/Pharmaceutical industry.
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 speeches and articles for publications that conform to prescribed style and format. Ability to effectively present information to top management, scientific and public groups, as well as to boards of directors.
MATHEMATICAL SKILLS
Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis.
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 multiple abstract and concrete variables.
CERTIFICATES, LICENSES, REGISTRATIONS
Must be able to travel both domestically and internationally.
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 sit. The employee is occasionally required to stand and walk; and work with hands. The employee must occasionally lift and/or move up to 25 pounds.
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.
The noise level is 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.
- Understanding of the basic science and engineering associated with the manufacture of pharmaceuticals
- Demonstrated expertise in chemical development and operations management
- Project management skills, planning, staffing, organizing, directing, and controlling
- Analytical problem-solving skills
- Working knowledge of regulatory issues in pharmaceutical manufacturing
- Leadership and negotiation skills
- Ability to build relationships, influence, and motivate others
- Coaching and mentoring skills
- Excellent written and oral communication skills and presentation skills
- Experience with international environments
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 December 15, 2025
