Principal Purification Chemist

Salary Range: $ To $ Annually

Responsible for providing strong technical leadership and documentation support for development and GMP manufacturing processes. 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.

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.

Include the following. Other duties may be assigned.

• Ensures that the purification chemistry is capable of meeting cost, yield, throughput, quality/purity, and QSHE goals on assigned processes in GMP plant production
• Leads the technical progress of large and/or multiple teams to accomplish the development, transfer, or implementation of technology at a lab or plant scale
• Develops and supports scalable purification processes and provides technical expertise and support during lab or GMP plant operations
• Responsible for supplying management with specific project data to facilitate the budgeting process for the development, transfer, or implementation of technology
• Develops and executes procedures, processes, and methods for solutions to purification and technical problems on lab and plant scale
• Conducts research and development to improve manufacturing processes
• Troubleshoots purification processes running in lab and GMP plant manufacturing
• Possesses an individual area of technical expertise, which others consult them for advice
• Adheres to GDP and SOPs in all aspects of work

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. Leads team in the development, troubleshooting, transfer, and improvement of purification and analytical processes. Gives regular reports to, and actively solicits feedback from, management.

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.

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.

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.

Doctoral Degree (Ph.D.) in Chemistry and one year of postdoctoral experience, preferably specializing in Purification Chemistry, plus five years of experience; or…