Research Scientist 3/Associate Director, Analytical Development Anacor Pharmaceuticals, Inc.
THIS JOB HAS EXPIRED Job Summary
The Research Scientist 3/Associate Director, Analytical Development, will be primarily responsible for working with internal and external team members to manage the drug substance and drug product stability programs executed at Contract Research Organizations. Other responsibilities will include analytical support of formulation development activities. The position reports to the Director, Analytical Development.
Manage external stability programs for drug substances and drug products
Coordinate stability testing activities at the contract organizations
Organize and review stability data packages
Provide analysis and trending of stability results and write stability reports
Provide analytical testing support of internal research and formulation development activities.
Support analytical development, method validation, and release testing at contract organizations
MS in Chemistry, Pharmaceutical Sciences, or related areas with 5+ years of relevant industry experience.
Hands-on experience and working knowledge of standard analytical techniques, including HPLC and GC method development and validation.
Experience with quality systems and cGMP requirements, and a thorough understanding of FDA and ICH requirements for the stability testing of drug substances and drug products
Experience in working with and monitoring activities at contract organizations
Excellent data analysis skills with attention to details and interpretation of results.
Well-organized, capable of multi-tasking, detail oriented and able to collaborate with individuals in a matrix environment
Excellent oral and written communication skills, including the ability to discuss scientific/technical data with team members and write technical reports
Experience in authoring CMC sections of regulatory filing documents is a plus.
To apply, please send email and resume to firstname.lastname@example.org
||Palo Alto, CA |
THIS JOB HAS EXPIRED