Principal Process Chemist - Peptide Focus

Principal Process Chemist - Peptide Focus

Regular Full-Time Professional Boulder, CO, US

3 days ago Requisition

Salary Range: $ To $ Annually

Responsible for providing strong technical leadership and documentation support for development and GMP manufacturing processes in the area of peptide manufacturing. Responsible for the planning and execution of multi-step syntheses from laboratory to full commercialization and supporting commercialization in the plant. 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.

• Ensures that the chemistry is capable of meeting cost, yield, throughput, and QSHE goals on assigned processes in GMP plant production
• Complete knowledge of peptide development and production: synthesis (SPPS, LPPS, Fragment Synthesis), crude, cyclization, purification, Lyophilization, and isolation by precipitation
• Leads in a matrix environment large and/or multiple teams to accomplish the peptide process development, transfer, or implementation of technology at a lab or GMP plant scale
• Strong knowledge and practical application of Quality by Design (QbD) principles, including:
  • Definition of QTPP, CQAs, CMAs, and CPPs
  • Risk assessments (e.g., FMEA, Ishikawa)
  • Design of Experiments (DoE) and multivariate data analysis
  • Strong knowledge of relevant ICH guidelines, ICHQ3A, Q3C, Q3B, Q3D, Q11, Q10, Q9, and ICHM7R(2)
• Develops and supports scalable peptide processes and provides technical expertise and support during lab and GMP 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 to improve manufacturing processes, improve on costs profile and process yield and throughput
• Possesses an individual area of technical expertise, which others consult them for advice
• Collaborates closely with Analytical Development, Manufacturing, QA, Regulatory, and external partners
• Provides expert input on project timelines, risks, and mitigation strategies
• Adheres to GDP and SOPs in all aspects of work

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.

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.

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.…