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. 
 

RESPONSIBILITIES:

• Conduct routine and non-routine analysis of in-process, toxicology, finished drug substance and drug product samples
• Develop drug substance specifications and author regulatory filings ensuring efficient integration across CMC and other relevant disciplines such as Clinical and Toxicology.
• Author scientific reports and portions of Chemistry, Manufacturing, and Controls (CMC) section of regulatory filings
• Review analytical data for compliance to SOPs and revise them
• Present and participate in internal and cross-functional scientific meetings
• Develop and optimize analytical methods
• Author and execute validation protocols and write reports
• Conduct analytical investigations
• Interface with outside parties, e.g., contract labs and partners.
• Applies knowledge of cGMP and GLP
• Manage one or more direct reports

REQUIREMENTS:

• BS or MS with at least 10 years of industry experience in Analytical Chemistry or a related major.
• Have a great understanding of the drug development process and key disciplines, including: Pre-clinical, technical CMC (drug substance/analytical & QC/drug product), Quality, Clinical, and Regulatory Affairs
• Experience following SOPs, e.g. analytical methods, equipment procedures, material specifications
• Excellent written/verbal communication skills, scientific, technical and critical thinking skills
• Hands-on analytical and lab experience in HPLC, GC and LC-MS
• Practical knowledge of GMP requirements

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