Sr. Purification Chemist
Corden Pharma - A Full-Service CDMO · Boulder, CO · 1 wk ago
AnalystFull-time
About the role
The Sr. Purification Chemist contributes to providing strong technical leadership and documentation support for development and GMP manufacturing processes. They are responsible for the planning and execution of multi-step preparative chromatography 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.
Responsibilities
- Develops and supports scalable purification processes and analytical methods while providing technical expertise and support during lab or plant operations
- Independently plans and executes experiments for the purification of peptides, toward developing a robust commercial process, while working on a project team
- Works effectively in a team-oriented environment
- Presents work orally and in form of written development reports
- Adheres to cGMP and SOPs in all aspects of work
- Demonstrates a clear understanding of technical issues and the requirements of a viable manufacturing process
- Ensures that the purification is capable of meeting cost, yield, throughput, quality, and QSHE goals on assigned processes
- Demonstrates positive attitude. Supports a positive, healthy, and flexible work environment that encourages employees and coworkers to develop their full potential and expand their horizons
- 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: 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
- Bachelor’s Degree (BS) in Organic or Analytical Chemistry and 2 years related experience and/or training in Purification Chemistry; or equivalent combination of education and experience
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
Skills
- Working knowledge of regulatory issues in Pharmaceutical Manufacturing including cGMPs, 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
- Ability to work interactively within a multi-functional team-oriented environment
- Takes initiative in setting own goals and work plan
- Broad technical knowledge in Purification Chemistry and Process Improvement Methodology
- 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
- 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
- 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
- Uses statistical design of experiments and draws sound conclusions from the results; uses results when solving problems or proposing improvements
- Provides leadership in all Purification Chemistry aspects of manufacturing processes; leads teams in the development, transfer, troubleshooting, and improvement of chemical processes in an 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
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 Parental Leave
- Tuition Reimbursement
- Wellness Program
- Vacation – Three Weeks 1st Year
- Vision Insurance
Pay
Actual pay will be based on your skills and experience.
Schedule
N/A