What are the responsibilities and job description for the Principal Process Chemist - TFF focus position at CORDEN PHARMA BOULDER INC?
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 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 providing strong technical leadership and documentation support for development and manufacturing processes. Responsible for the planning and execution of multi-step syntheses from laboratory to full commercialization. Emphasis is on the creative application of a full range of literature and theoretical concepts from a diverse range of chemistry to the design and implementation of cost-effective processes for the manufacture of Corden pharmaceuticals.
Works within a team-oriented environment with professionals from a variety of disciplines. Conducts research, analysis, synthesis, experimentation, and documentation for such purposes as process development, implementation, registration, validation, and process improvement.
ESSENTIAL DUTIES AND RESPONSIBILITIES
Include the following. Other duties may be assigned
- Experienced in lab TFF/ultra filtration processing development and plant scale up in GMP setting
- Familiar with various types of TFF filtration methods and systems
- Experienced in key operating/scalable parameters for TFF/ultra filtration and ability to determine such parameters during process familiarization/ optimization
- Ensures that the chemistry is capable of meeting cost, yield, throughput, and QSHE goals on assigned processes
- Leads large and/or multiple teams to accomplish the peptide process development, transfer, or implementation of technology at a lab or plant scale
- Develops and supports scalable peptide processes and provides technical expertise and support during lab and/or plant operations
- Responsible for supplying management with specific project data to facilitate the budgeting process for the development, transfer, and/or implementation of technology
- Develops and executes procedures, processes, and methods for solutions to chemical and technical problems on lab and/or plant scale
- Conducts research and development in order to improve manufacturing processes
- Possesses an individual area of technical expertise, on which others consult them for advice
- Adheres to GDP and SOPs in all aspects of work
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. Leads team in the development, troubleshooting, transfer, and improvement of chemical and analytical processes. Gives regular reports to and actively solicits feedback from management.
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
Doctoral Degree (PhD) in Organic Chemistry/Biochemistry, plus 5 years of experience; or equivalent combination of education and experience. GMP and TFF/ultra filtration experiences are required. Peptide experience is preferred.
LANGUAGE SKILLS
Ability to read, analyze, and interpret common scientific and analytical 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 SKILLS
Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, ratio, and percent, and to draw and interpret bar graphs.
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.
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 is occasionally required to work with hands; 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 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and 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 accommodation may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is frequently exposed to fumes or airborne particles and low levels of toxic or caustic chemicals. The employee is occasionally exposed to moving mechanical parts, outside weather conditions, and risk of electrical shock. 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 necessities.
- Demonstrates a positive attitude
- Maintains a well-documented record of work performed in a laboratory notebook, laboratory reports, and campaign reports
- Experience in the synthesis and purification of peptides
- Experienced in lab TFF/ultra filtration processing development and plant scale up in GMP setting
- 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; and 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 simultaneously) 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
- Thorough working knowledge of regulatory issues in pharmaceutical manufacturing, including cGMPs, GDP, FDA, ICH, PSM, OSHA, EPA requirements, and process hazard analysis; can interpret regulatory laws, and propose, defend, and implement cost-effective solutions
- Computer skills, in the areas of: Microsoft Office Products – Word, Excel, PowerPoint; statistical analysis programs, Chemdraw and SciFinder, Laboratory Information Management System, and business systems (SAP)
- Develops special expertise in products and processes; acknowledged as an expert in one or more technical areas, both within and outside site
- Creates clear, concise goals and strategies that support individual’s development and the site’s mission; actively participates in proposing and setting Process Chemist Group and Manufacturing Department goals
- Routinely demonstrates a proactive approach to problem identification and resolution
- Understands Corden’s business goals and contributes technically to its strategy development
- Interacts with management in developing project objectives and site strategies; advises management regarding technical opportunities and advances
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 post will expire on April 30, 2025
