Principal Process Chemist - Peptide Focus

Corden Pharma is a leading full-service Contract Development and Manufacturing Organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, drug products (DPs), and packaging. With around 3,000 employees worldwide, we help pharmaceutical, and biotech companies manufacture medicines with the ultimate goal of improving people's lives.

Our network, spanning Europe and the U.S., provides flexible and specialized solutions across six technology platforms:
Peptides, Lipids & Carbohydrates, Injectables, Highly Potent & Oncology, Small Molecules, and Oligonucleotides. We strive for excellence in supporting this network and are committed to delivering the highest quality products for patient well-being.

Our People Vision

We strive for excellence. We share our passion. Together, we make a difference in patients' lives.

SUMMARY

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.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Include the following. Other duties may be assigned

• 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

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.

QUA…