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.
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
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
- 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
SAFETY & ENVIRONMENTAL RESPONSIBILITIES
QUALITY RESPONSIBILITIES
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
EDUCATION and/or EXPERIENCE
LANGUAGE SKILLS
MATHEMATICAL SKILLS
REASONING ABILITY
CERTIFICATES, LICENSES, REGISTRATIONS
PHYSICAL DEMANDS
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
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
- 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