Senior Research Associate, Analytical Development GLP Assay Support

As a member of the Analytical Development group this position is responsible for performing GLP method validation and GLP analytical assay support for early-stage research programs. The individual will collaborate with Early Research Process Development, Gene Therapy Research, and additional internal and external stakeholders to support nonclinical GLP studies.

Primary Responsibilities Include:

Designs and performs method validations and analytical testing to support release and stability testing of AAV based gene therapy products

Perform Quantitative Polymerase Chain Reaction (qPCR), Droplet Digital PCR (ddPCR), Immunoassays, In Vitro Potency, and additional AAV characterization assays

Works seamlessly with cross functional stakeholders

Participates in project related teams and other internal/external collaborations

Ensures that scientific and technical challenges are resolved in a timely manner

Maintains all appropriate laboratory records and authors Standard Operating Procedures (SOPs), technical documents, protocols, methods, and reports

Performs routine data analysis and visualization for use in presentations, publications, and internal reports

Contributes to a safe, efficient, and effective environment with personal accountability

Performs other related duties as required

Desired Education and Skills:

AS degree in scientific discipline with 8+ years of experience, BS degree in scientific discipline with 5+ years of experience, or MS degree in scientific discipline with 3+ years of experience in the biotech/pharmaceutical industry

3+ years of relevant industry experience in method development, validation, and analysis performing cell and molecular assay techniques (e.g., qPCR, ddPCR, CE, ELISA, cell culture, TCID50)

Experience working in a regulated (GLP / GMP) environment

Understanding of relevant FDA, EU, and ICH regulatory guidelines and pharmacopeia as applicable to analytical method validation and testing for gene therapies

Excellent written and verbal communication skills

Proven record of successfully planning experiments and executing projects in collaboration with internal or external stakeholders

Proven ability to work independently and effectively handle multiple priorities is a must

Ability to maintain confidentiality of proprietary information expected

#LI-Onsite

This position requires work on site at one of Sarepta’s facilities in the United States.

The targeted salary range for this position is $76,000 - $95,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta’s compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.

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.

R-02431