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Senior Analytical Chemist

2 months ago

Boulder, Colorado, United States CORDEN PHARMA BOULDER INC Full time
Job Overview

Corden Pharma Boulder Inc is an esteemed contract development and manufacturing organization (CDMO) specializing in active pharmaceutical ingredients (APIs), excipients, and drug products. With a workforce exceeding 2,600 globally, we are dedicated to facilitating pharmaceutical and biotech companies in the production of medicines aimed at enhancing the quality of life for patients.

Our operational network spans Europe and the U.S., providing tailored solutions across various technological platforms, including Peptides, Lipids, & Carbohydrates; Injectables; Highly Potent & Oncology; and Small Molecules. We are committed to excellence in supporting this network and ensuring the highest quality products for patient welfare.

Position Summary

The role involves conducting analytical research and development to enhance manufacturing processes and technologies, alongside producing clinical trial batches. Key responsibilities include:

  • Engaging in the development of innovative processes utilizing advanced analytical skills and techniques, including mass spectrometry (MS, LC/MS, LC/MS/MS, and GC/MS).
  • Implementing analytical methodologies at a process scale, such as process chromatography.
  • Leading the creation and execution of new analytical chemistry methodologies.
  • Understanding and applying internal, corporate, and ICH stability guidelines to support the Corden Pharma Stability Program.
  • Documenting analytical procedures and reports that support clinical and commercial manufacturing as well as regulatory requirements.
  • Developing and transferring key technologies that are effective in a manufacturing context.
  • Overseeing the analytical components of process documentation.
  • Acting as an analytical resource within R&D teams.
  • Formulating analytical research proposals, including project objectives, applications, costs, and resource needs.
  • Creating, implementing, and validating analytical methods and procedures.
  • Maintaining comprehensive documentation of research findings and project status.
  • Participating in troubleshooting and resolving analytical issues during manufacturing.
  • Acquiring knowledge of Quality, Environmental, Health & Safety (QEH&S) principles and regulatory affairs.
  • Analyzing and approving batches of drug substances for clinical or registration purposes.
  • Managing hazardous and non-hazardous waste responsibly.
Leadership and Team Collaboration

Collaboration within project teams is essential, fostering a positive and flexible work environment that promotes the growth of all employees.

Safety and Environmental Commitment

Every employee is accountable for the safety and environmental aspects of their work, expected to perform duties safely and responsibly.

Qualifications

Successful candidates will possess:

  • A Doctoral or Master's degree in Chemistry with at least 2 years of relevant experience; or a Bachelor's degree with 6 years of related experience; or an equivalent combination of education and experience.
  • Strong analytical and problem-solving skills, with the ability to interpret complex technical instructions.
  • Excellent communication skills, both written and verbal, with the ability to present information effectively.
  • Familiarity with cGMP and GLP standards.
Physical and Work Environment

The role may involve exposure to hazardous materials and requires adherence to safety protocols. Reasonable accommodations will be made for individuals with disabilities.

Core Competencies
  • Presentation and persuasion skills
  • Training and facilitation abilities
  • Strong written and verbal communication
  • Comprehensive understanding of regulatory standards
Compensation and Benefits

Compensation will be commensurate with experience and skills, alongside a comprehensive benefits package.