Sr. Process Chemist - TFF focus

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 QEH&S 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 QEH&S 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.

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.

• Demonstrates a positive attitude
• Strong background in chemistry or a related scientific field
• Working knowledge of regulatory issues in pharmaceutical manufacturing including cGMPs, GDP, FDA, PSM, OSHA, and EPA requirements
• Communicates effectively in writing and verbally within the department
• Computer skills, in the areas of: Microsoft Office Products (Word, Excel, PowerPoint), Chemdraw, and SciFinder
• Ability to work interactively within a multi-functional team-oriented environment
• Takes initiative in setting own goals and work plans
• Hands on organic chemistry laboratory experience
• Has broad technical knowledge in organic chemistry and process improvement methodology
• Maintain a well-documented record of work performed in a laboratory notebook, laboratory reports, and campaign reports
• Experience in the synthesis and purification of peptides (desired)
• Has working knowledge of all plant-scale unit operations, scale-up, and plant design considerations
• 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; has demonstrated 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
• Ability to understand and apply statistical design of experiments and draw sound conclusions from the results; uses results when solving problems, or proposing improvements
• Ability to provide leadership in all process chemistry aspects of manufacturing processes; leads teams in the development, transfer, troubleshooting, and improvement of chemical processes in interactive, interdisciplinary team environment
• Seeks out opportunities to learn manufacturing needs and methods that facilitate substantial process improvements; acquires new skills in state-of-the art technology and applies it to their assignments
• Demonstrates skills in negotiation and influencing others
  
  

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 3/31/2025