Scientist - Analytical Development

Research Triangle Park, NC, United States
Sep 17, 2020
Bio NC
Required Education
Bachelors Degree
Position Type
Full time
We are seeking a Scientist, Analytical Development, to assist in the design, development, qualification and execution of analytical assays to support in-process analytics, process development, non-clinical recombinant adeno-associated virus (rAAV) vector manufacturing and GMP rAAV vector manufacturing. This individual provides analytical test methods development, qualification and validation support for future non-GMP and GMP drug product release.

Responsibilities and Accountabilities
  • Assist scientists in the design and execution of molecular biology analytical assay development and qualification protocols related to viral titer assays, residual DNA assays, sequencing, etc. that include TCID50, qPCR, ddPCR, PCR, Sanger and NGS sequencing
  • Provide analytical testing support for process development, R&D and external CMO teams, when needed, to assist in the development and analytical characterization of new therapeutic targets
  • Ensure lab areas are clean and organized and equipment, supplies and raw materials are available for use
  • Execute qualification/validation of developed analytical methods
  • Author development reports, study protocols, SOPs and pre-validation reports
  • Contribute to technical discussions and investigations within the Analytical group
  • Detailed, organized, formal record keeping
  • Excellent communication skills and works well in a group environment

About you:
  • BS or MS in bioanalytical chemistry, biology, biochemistry, virology or related field with at least 1-3 years' experience
  • Must possess skills in qPCR, ddPCR and other molecular biology techniques
  • Prior experience in analytical method development setting for analytical assays is a must
  • Ability to multi-task among multiple projects and teams and work independently in a fast-paced, highly interactive environment
  • Excellent interpersonal skills with the ability to interact effectively with people, internally and externally is required
  • Must be self-motivated, organized, capable of working independently, as well as in a collaborative/group environment to collaborate with manufacturing process development staff on experimental studies
  • Familiarity with method development and validation following regulatory guidelines (USP, ICH, etc.)
  • Possess strong oral and written communication skills
  • Must exhibit analytical method development skills with use of statistics and design of experiments (highly desirable)
  • Good judgment and innovation to achieve a solution within standard practices and procedures