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.
- 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
- 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
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