Scientist II/Sr. Scientist, Analytical Chemistry at Sarepta Therapeutics in andover, Massachusetts

Posted in Other 1 day ago.

Job Description:

This individual will be engaged in developing and validating complex analytical test methods to support multiple early, mid and late phase oligonucleotide products in the Analytical Development department for novel RNA-based therapeutics. The individual will also develop and validate various analytical methods, including but not limited to chromatography, gel/capillary electrophoresis. The individual will lead in the area of biophysical characterization and assay development for AAV gene therapy products.

AAV gene therapy experience is recommended. Transfers methods from Analytical Development (AD) to Quality Control (QC) and manage lifecycle of analytical methods. The candidate will write methods, standard operating procedures, method qualification/validation protocols and reports. The individual will transfer these methods to end users in contract testing laboratories or contract testing sites in the US and in Europe. The individual will engage in trouble shooting existing methods and conducting continuous improvement on existing methods. The position may have direct reports.

This position reports to the Director of Analytical Development.

Primary responsibilities include:

  • Establishing multiple methods for assessment of viral capsid protein content, composition, and quality (ELISA, HPLC, CE, AUC LC-MS, etc)

  • Utilizing chromatography-based methods for impurity detection and characterization from multiple steps in viral vector production

  • Provide oversight to the development, qualification, validation of various chromatography, mass spectrometric methods for oligonucleotide-based therapeutics

  • Responsible for performing routine and non-routine analytical tests of raw materials, Oligonucleotide in-process samples, finished products, and stability samples using HPLC, GC, UV/VIS, MALDI-TOF and LC-MS;

  • Have the knowledge and ability to conduct USP, EP and JP testing per these compendia.

  • Conducts laboratory activities at the Sarepta in-house laboratories, transfers methods from Analytical Development (AD) to Quality Control (QC) and manage lifecycle of analytical methods;

  • Acts as company liaison with CTOs to coordinate in method development and method transfer across various Contract Manufacturing Organization (CMO)/ Contract Research Organization (CRO) sites;

  • Creates and maintain clear and concise lab records and documentation, especially as the tests of finished products and the stability samples will be used to ensure compliance with the FDA regulation Author development reports, study protocols, pre-validation and validation reports, comparability reports, SOP and test methods.

  • Mentor junior members of the team, train both internal and external laboratory staf. Learn and deploy novel analytical methods to the Sarepta laboratory.

Education and Skills Requirements:

The absolute minimum requirements for the Scientist, Analytical Chemistry position is a Doctorate Degree in Chemistry, Analytical or Medicinal Chemistry, or Pharmaceutical related sciences with the course work emphasis in chemistry (foreign equivalent degrees accepted) and at least five years of industry related experience working with peptides, proteins method development experience.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.