QC Analyst

Location
Lexington, MA
Posted
Oct 23, 2018
Discipline
Quality, Quality Control
Required Education
Bachelors Degree
Position Type
Full time

Wave Life Sciences is seeking an experienced QC Analyst to join a growing QC/Analytical Development function at a newly commissioned, state-of-the-art oligonucleotide therapeutics manufacturing facility.  The QC Analyst will be responsible for the implementation and routine use of analytical test methods in support of process development, GMP production, and stability testing.  Primary methods include HPLC/UPLC, UV-Vis, FTIR, Karl-Fischer, MS and several wet chemical QC methods.  Particular emphasis may be on developing GMP systems and processes for a range QC functions including: raw material testing, environmental/facility monitoring, microbiology.  The successful candidate will also contribute to method life cycle management, new method qualification/validation and method troubleshooting.    

Candidates must have hands-on experience and demonstrated organizational skills in a regulated analytical/QC environment, preferably in the pharmaceutical or biotech industry.  Experience with GxP documentation is preferred, as is the ability and desire to adapt and learn in a fast pace dynamic environment with rapidly changing priorities.  The position offers an opportunity to build QC systems and contribute to the overall success of manufacturing operations at Wave.  This position also offers the opportunity to grow expertise in oligonucleotide therapeutics, which is an emerging and rapidly growing therapeutic class.  Although direct experience in oligonucleotide methodologies is not required, candidates with prior oligonucleotide or peptide experience are encouraged to apply.

Responsibilities:

  • Analyzes samples from manufacturing and process development departments.
  • Implementation of QC methods to support raw material testing and tracking.
  • Contribute to development, troubleshooting, improvement and life-cycle management of analytical methods.
  • Write, review and approve GMP documentation (SOPs, test methods, protocols, technical reports, specifications, etc.).
  • Identifies, evaluates, and procures analytical equipment and reagents to enhance capabilities of the department.
  • Network with peers in manufacturing, process development, engineering and quality assurance departments.
  • Supports method qualification and validation.
  • Reviews data packages generated by other analysts.
  • Develops strong rapport with colleagues in the QC/Analytical department, as well as with colleagues in Quality Assurance, Manufacturing and Process Development.
  • Independently applies scientific knowledge (both theoretical and practical) for the resolution of analytical chemistry problems.
  • Works effectively and efficiently with external labs to provide testing and development support for Wave’s programs.

Education / Experience:

 

  • BS in Chemistry, Biochemistry, Biotechnology (or related discipline) with a minimum of 3 years of experience in a pharmaceutical/biotech/cGMP environment.
  • MS in Chemistry, Biochemistry, Biotechnology (or related discipline) with a minimum of 2 years of experience in a pharmaceutical/biotech/cGMP environment.
  • At least 1 year of experience with chromatographic methods for small molecule, protein, peptide or oligonucleotide analysis.
  • Experience with a range of analytical chemistry, biochemistry or biophysical methods, including Karl-Fischer, UV-Vis, FT-IR, Gas Chromatography or drug product formulation.
  • Full computer literacy, knowledge of basic scientific principles and practices, and ability to effectively communicate and collaborate both verbally and in written communications.
  • Familiarity with the following are of additional value: microbiology, sample tracking, raw material testing, environmental monitoring.