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-TG1

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.