Job Description

Job Description

Job Description

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.

Corden Pharma is a leading full-service contract development and manufacturing organization (CDMO) of active pharmaceutical ingredients (APIs), excipients, and pharmaceuticals Drug Products (DP) and packaging capabilities with > 2,600 employees across the world. Our services enable pharmaceutical and biotech companies to manufacture medicines with the ultimate goal of improving people’s lives.

Our network in Europe and the U.S. offers flexible and specialized solutions across five technology platforms: Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.

SUMMARY

Responsible for ensuring the purification of assigned processes is robust and is capable of meeting yield, throughput, purity/quality, and QSHE goals. Identifies process improvement opportunities on existing processes and helps implement solutions. Participates in technology transfers. Troubleshoots assigned purification processes and identifies and implements problem prevention solutions. Performs and interprets in process control checks.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned.

• Performs analytical and preparative-scale chromatography in a lab environment
• Conducts analyses of samples using established or routine methods
• Provides technical support to lab or plant processes
• Works effectively in a team-oriented environment
• Presents work orally and in the form of written development reports
• Adheres to cGMP and SOPs in all aspects of work
• Independently plans and executes experiments, while working in a project team toward development of viable commercial processes
• Demonstrates a clear understanding of technical issues and the requirements of a viable manufacturing-scale purification process
• Executes procedures, processes, and methods for solutions to purification and technical problems on a lab or plant scale

LEADERSHIP & BUDGET RESPONSIBILITIES

None. Provides technical expertise to manufacturing.

SAFETY & ENVIRONMENTAL RESPONSIBILITIES

Every individual is personally responsible for the safety and environmental aspects of their 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

Bachelor's Degree in Organic or Analytical Chemistry from four-year college or university; or equivalent combination of education and experience.

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 publication that conform to prescribed style and format. Ability to effectively present information to top management, public groups, and/or boards of directors.

MATHEMATICAL SKILLSAbility 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 ABILITYAbility to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with nonverbal symbolism (formulas, scientific equations, graphs, musical notes, etc.,) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables.CERTIFICATES, LICENSES, REGISTRATIONS

None.

PHYSICAL DEMANDSThe 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; and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, distance vision, and color vision.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. 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.

• Demonstrates a positive attitude
• Strong background in Purification Chemistry or a related scientific field
• Working knowledge of regulatory issues in Pharmaceutical Manufacturing including cGMPs, PSM, OSHA, and EPA requirements
• Communicates effectively in writing and verbally
• Computer skills in the areas of Microsoft Office Products – Word, Excel, and PowerPoint
• Ability to work interactively within a multi-functional team-oriented environment
• Takes initiative in setting own goals and work plan
• Hands on purification laboratory experience
• Has broad technical knowledge in Purification Chemistry and Process Improvement Methodology
• Maintains a well-documented record of work performed in a laboratory notebook, laboratory reports, and campaign reports
• Experience in the purification of Peptides
• A working knowledge of all plant-scale purification unit operations, scale-up, and plant design considerations
• An understanding of chemical reactivity, potential exotherms, cross reactivity, side products, and waste streams; especially for processes they support
• Regularly seeks out new learning opportunities beyond basic skills that can result in innovative approaches to technical issues
• Demonstrates clear understanding of technical issues and the requirements of a viable manufacturing process; demonstrates independent support on multiple (not necessarily simultaneous) processes
• Identifies areas where change/continuous improvement is beneficial to the business, and successfully defends and implements projects
• Assumes reasonable risk in trying out new, self-generated ideas
• Proactive approach to problem identification and resolution
• Communicates effectively in writing and verbally within and across departments and to site management; updates are clear, selective, and effective

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 Maternity/Paternity Leave
• Tuition Reimbursement
• Wellness Program
• Vacation – Three Weeks 1st Year
• Vision Insurance

This posting will expire on 11/10/2025

Job Tags

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

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