We are seeking a hands-on team player who enjoys collaborating with colleagues and shares a passion for seeking gene therapy cures for devastating diseases and making a difference for patients. The candidate in this role will be supporting method transfer from the analytical development group and the establishment of cell-based assays in the process analytics laboratory. Technical proficiency in analytical methodologies (cell-based assays, qPCR, ddPCR, and Jess Western Blot) for drug substances and drug products is required for gene-based products.
The candidate must be able to multitask and demonstrate flexibility. Working experience in gene therapy with cell-based assays is required. We are looking for an enthusiastic, highly organized, and motivated individual who will work on-site within the Gene Therapy Process Development-Process Analytics team at the Burlington, MA, location.
Primary responsibilities include:
Perform method transfer, optimization, and qualification of cell-based assays such as infectivity and potency assays.
Support Process Analytics operations of sample testing, including assay execution and data analysis for infectivity, potency, qPCR, ddPCR and Jess Western Blot assays.
Manage reference material qualifications and data trending for cell-based assays to monitor the assay performance.
Strong analytical skills to troubleshoot and investigate issues from the testing.
Follows good documentation procedures, such as ELN, per regulatory requirements.
Author and review technical documents (protocols, reports, and test methods).
Work with cross-functional peers and present data in group meetings.
Ability to interact and cooperate cross-functionally and ability to effectively work in a fast-paced environment.
Desired Education and Skills:
B.S./MS degree in molecular biology, virology, or equivalent with 3-5 years of hands-on experience in cell-based assays, or a Ph.D. with 0-1 years of relevant experience.
A strong understanding of assay design, method qualification, and troubleshooting principles.
Hands-on experience in cell-based, ddPCR, qPCR and Jess Western Blot assays.
Organization, multitasking, attention to detail, and adherence to timelines.
Operate as a part of a team with experience in hands-on training individuals in a laboratory environment.
Support team members and deliver lab responsibilities as assigned.
Excellent written and verbal communication skills.
#LI-Onsite Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.