Senior Analytical Chemist I

Position Summary

The Senior Analytical Chemist I performs activities to design, develop, qualify and validate analytical methods for the characterization, release testing and stability testing of active pharmaceutical ingredients (API). You will be responsible for developing analytical tools for determining impurities, purity and/or assay of starting materials, intermediates, in-process and final drug substances. The chemist will also be responsible for training/mentoring junior analytical chemists and method transfer to in-house QC department. Additional duties will include representing the analytical team on internal and external cross-functional project teams and establishing relationships/quotes with external testing laboratories.

Responsibilities will include:

•    Understand analytical techniques typical for active pharmaceutical ingredient characterization and release testing
•    Communicate directly with clients and contractors to facilitate completion of assigned projects
•    Effectively communicate technical information to a nontechnical audience
•    Independently transfer, develop, and/or validate analytical methods including but not limited to HPLC, LC/MS, GC, GC/MS, FTIR, KF, ROI and LOD
•    As Lead Analytical Chemist, collaborate with the Project Manager and other team members to write project research plans, establish project timeline, determine analytical milestone deadlines, and execute complex method development projects
•    Independently prepare samples and solutions
•    Author validation protocols, validation reports, test methods, analytical development reports, SOPs, and data packets to support assigned projects
•    Facilitate the transfer of analytical methods to Woodruff Site and train QC chemists as needed
•    Perform release testing of non-GMP batches 
•    Characterization of reference standards and drafting COAs
•    Develops drug substance specifications with synthetic chemists and QA
•    Participate in OOS, deviations and LIRs with qualified investigators and management
•    Demonstrate an understanding of cGMP/GLP practices, SOPs, and systems applicable to work performed
•    Understand and apply ICH and FDA guidance effectively
•    Independently setup and breakdown instruments and perform instrument qualifications
•    Provide mentorship for Analytical chemists
•    Peer-review colleagues’ analytical data, results, documentation, and reports

Required Experience & Knowledge

•    Minimum B.S. degree in a scientific discipline, Chemistry or Biochemistry with 7 years of applicable laboratory experience, or M.S. degree in Chemistry or Biochemistry with 3 years of applicable laboratory experience, or PhD. degree with 1 year of applicable laboratory experience
•    Preferred B.S. degree with 10 years, or M.S. degree with 5 years, or PhD. with 1 year of experience
•    Pharmaceutical analysis or related industry experience required
•    GMP experience preferred

Physical Demand / Work Environment

•    Works in a laboratory environment
•    Must be able to work safely with chemicals and hazardous materials
•    May work at one or both Actylis sites in Eugene and may travel between sites as needed
•    May sit or stand for long periods of time
•    May lift up to 40 pounds with or without reasonable accommodation 

Supervisory Responsibilities

None