Sr. Purification Chemist

Overview

The Sr. Purification Chemist contributes to providing strong technical leadership and documentation support for development and GMP manufacturing processes. Responsible for planning and execution of multi-step preparative chromatography from laboratory to full commercialization. Emphasis is on the creative application of literature and theoretical concepts to design 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 process development, implementation, registration, validation, and process improvement.

• Develop and support scalable purification processes and analytical methods while providing technical expertise and support during lab or plant operations.
• Independently plan and execute experiments for purification of peptides toward developing a robust commercial process, while working on a project team.
• Work effectively in a team‑oriented environment.
• Present work orally and in written development reports.
• Adhere to cGMP and SOPs in all aspects of work.
• Demonstrate a clear understanding of technical issues and requirements of a viable manufacturing process.
• Ensure the purification can meet cost, yield, throughput, quality, and QSHE goals on assigned processes.

• Bachelor’s Degree in Organic or Analytical Chemistry and at least 2 years of related experience and/or training in purification chemistry, or equivalent combination of education and experience.
• Ability to read, analyze, interpret, and write scientific journals, reports, and regulatory documents.
• Basic mathematical skills: proportional reasoning, percentages, unit conversions, basic algebra and geometry.
• Logical and scientific reasoning ability to analyze complex problems and apply scientific methods to demonstrate cause and effect.
• No required certifications, licenses, registrations.

Physical demands: employee is regularly required to talk or hear, stand, walk, and sit; may need to use hands, reach above shoulder height, climb, balance, stoop, kneel, crouch, crawl, and occasionally lift or move up to 50 pounds. Vision requirements include close, distance, color, peripheral, and depth perception. Specific tasks may involve exposure to fumes, airborne particles, and low levels of toxic or caustic chemicals.

Noise level is moderate.

• Demonstrates a positive attitude.
• Strong background in Purification Chemistry or a related scientific field.
• 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.
• Hands‑on purification laboratory experience.
• Broad technical knowledge in Purification Chemistry and Process Improvement Methodology.
• Maintain a well‑documented record of work performed in a laboratory notebook, laboratory reports, and campaign reports.
• 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.
• Demonstrates 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.
• Assumes reasonable risk in trying out new, self‑generated ideas.
• Proactive approach to problem identification and resolution.
• Communicates effectively in writing and verbally…