Sr. Process Chemist - TFF focus

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.

CordenPharma 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 six technology platforms : Peptides; Lipids & LNPs; Injectables; Highly Potent & Oncology; and Small Molecules; and Oligos. We strive for excellence in supporting this network and are committed to providing the highest quality products for the well-being of patients.

SUMMARY

Acts to drive and demonstrate the technology for the planning and execution of development and implementation of chemical processes. Ensures that the chemistry is sufficient to meet goals on process yields, throughputs, and QSHE requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned :

• Familiarity with general TFF / ultra filtration setup, operation, and components
• Experience with lab and / or mid-large scale TFF / ultra filtration processing
• Knowledge of various types of TFF filtration methods and systems
• Understanding of key operating / scalable parameters for TFF / ultra filtration and ability to determine such parameters during process familiarization / optimization
• Provides technical support to lab or plant processes
• Works effectively in a team-oriented environment
• Presents work orally and in form of written development reports
• Adheres to GDP 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 process
• Executes procedures, processes, and methods for solutions to chemical and technical problems on a lab or plant scale
• Ensures that the chemistry is capable of meeting cost, yield, throughput, and QSHE goals on assigned processes
• Leads a team to accomplish the development, transfer, or implementation of technology at a lab or plant scale
• Develops and supports scalable processes and provides technical expertise and support during lab or plant operations

LEADERSHIP & BUDGET RESPONSIBILITIES

Demonstrates a positive attitude. Supports a positive, healthy, and flexible work environment that encourages employees and coworkers to develop their full potential and expand their horizons. This position has no supervisory responsibilities. 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 (BS) in Organic Chemistry and 5 years related experience and / or training; or equivalent combination of education and experience. TFF / Untra filtration experience is required; and Peptide and GMP experience is a plus.

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 develop bench scale laboratory procedures into step-by-step operating instructions for chemical operators. Ability to effectively present information to top management, public groups, and / or 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 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, etc.) in its most difficult phases. Ability to deal with a variety of abstract and concrete variables. Ability to apply scientific methods to experimentally prove cause and effect.

CERTIFICATES, LICENSES, REGISTRATIONS

Domestic and international travel required.

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 stand, walk, and sit. 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.

This posting will expire on 3 / 31 / 2025