We are a leader in RNA-targeted therapy, pioneering new markets and changing standards of care with our novel antisense technology. We currently have three marketed medicines and a premier late-stage pipeline highlighted by industry-leading cardiovascular and neurological franchises. 

We are building upon our innovative research and drug development excellence to provide greater value to patients, and we are looking to hire a Senior Scientist of Analytical Development & QC. 

PRIMARY RESPONSIBILITIES:

• Conduct routine/non-routine analysis of in-process, toxicology, finished drug substance and drug product samples (i.e. release and stability testing)
• Review analytical data for compliance to SOPs (e.g. Analytical Methods, Equipment Procedures, Material Specifications)
• Assemble and document data for quality review
• Revise SOPs as needed (e.g. Analytical Methods, Equipment Procedures, Material Specifications)
• Author and execute qualification/validation protocols and write reports
• Author scientific reports and portions of Chemistry, Manufacturing, and Controls (CMC) section of regulatory filings
• May develop and/or optimize analytical methods
• Applies knowledge of cGMP and GLP on a daily basis

REQUIREMENTS:

• BS/MS degree in Chemistry or related field
• 5+ years (Research Associate) or 10+ years (Sr. Research Associate) experience in an analytical development and quality control role
• Practical knowledge of HPLC, MS, and GC
• Knowledge and previous applications of cGMPs preferable
• Experience following SOPs (i.e. Analytical Methods, Equipment Procedures, Material Specifications)
• Experience recording data in laboratory notebooks or data collection forms
• Comfortable with the operation and troubleshooting of instrumentation (lab equipment)
• Communicate effectively, both verbally and in written form, to all levels of the organization
• Experience managing development projects

Reach out to:
alanah@peoplewithchemistry.com
858-429-5147