Associate Director, Analytical Development/QC

111453
  • 111955 USD - 147175 USD
  • Carlsbad, United States
  • Permanent
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
Alanah Gaudreau Resourcer

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