Development or Validation Chemist
Summary
In this hands-on position, the primary responsibilities of the Chemist will be to develop and validate analytical methods for testing raw materials, in-process samples and finished drug products and/or to develop nasal spray formulations. This position is also responsible for extensive technical writing, leading analytical and formulation development projects for nasal spray products and for designing, executing and summarizing a wide range of studies.
Essential Functions:
- Perform method development, assay validation and characterization for multiple products
- Formulate and design nasal spray drug products using QbD methodologies
- Manage and participate on project teams
- Perform data reviews, prepare reports and quality documents
- Prepare analytical sections of regulatory filings
- Author technical reports, SOPs, validation protocols, regulatory sections in CTD format and other cGMP related documents
Knowledge, Skills and Abilities:
The individual must have experience in an FDA regulated cGMP laboratory environment. Additionally, the Chemist possesses:
- Extensive technical experience in analysis and development of pharmaceuticals
- Comprehensive understanding of small molecule chemistry
- Understanding of current Good Manufacturing Practices (cGMPs)
- Demonstrated knowledge of modern analytical techniques, including HPLC. Knowledge of nasal spray characterization a plus.
- Experience in development and validation of methods destined for QC in the pharmaceutical industry
- Proven team player with well-developed interpersonal and mentoring skills, excellent organizational skills, communication skills, including written documentation skills and presentation skills
Minimum Qualifications:
- Bachelors degree in Chemistry or related field with not less than five years of relevant experience in an FDA regulated cGMP environment
- Outstanding capabilities for multitasking and adjusting priorities in response to changing conditions and schedules
- Experience with nasal spray drug product development and characterization preferred
Success Factors:
- Enthusiasm for building a company
- Enthusiasm for working in teams and collaborating with both internal and external colleagues
- Substantial expertise in small molecule chemistry
- Interest in applying new technologies
- Ability to use resources to tenaciously resolve problems and close projects