Senior QC Associate

Sarepta Therapeutics•Andover, MA

4d•Onsite

About The Position

This individual will support quality control activities including management of a centralized program governing reference standards and critical reagents used across a wide network of QC labs in the testing and release of clinical and commercial products. This individual will also support assay lifecycle processes, such as method optimization, qualification/validation and tech transfer activities. The work involves generation and qualification of critical reagents, maintaining inventory, and stability related tasks to support AAV and siRNA-based product testing at the Andover Sarepta site and at contract labs. The individual will conduct laboratory support processes such as maintaining cell cultures, generating and analyzing data, and maintaining GMP records. In addition, the individual will contribute to assay optimization and qualification/validation activities for cell and molecular biology assays being conducted internally at Sarepta Andover as well as tech transfers to external partners as SME for analytical methods. The individual will support the team manager in managing quality events (OOS, OOT, Deviation, Change Control etc.) and data trending. All aspects of this position would involve working in a GMP compliant manner. This position is onsite 5 days a week.

Requirements

B.S. degree in a scientific discipline with at least 5-8 years relevant experience (B.S.) or a M.S. with at least 2-5 years relevant experience.
Working experience in a cGMP environment is required.
A strong understanding of cell culture methods, Jess/Capillary electrophoresis western blotting, polymerase chain reaction (PCR), agarose gel electrophoresis, SDS-PAGE, ELISA, and spectrophotometric assays is required.
Hands on experience running protein-based immunoassays and/or qPCR/ddPCR assays.
Experience in general laboratory organization, experimental design, and documentation (GDP) with adherence to cGMP is necessary.
Strong interpersonal skills and a proven ability to communicate effectively through verbal and written formats.
Self-starter with the ability to work in a fast-paced, cross-functional, highly collaborative environment.
Must have effective written and verbal communication skills.
Operate as part of a team, assisting associates in providing a functional, safe working environment while maximizing laboratory efficiency.
Candidates must be authorized to work in the U.S.

Nice To Haves

A familiarity with regulatory (FDA, EU, etc.) and compendial (USP, EP, etc.) guidance is highly desired.
Experience in developing, validating, optimization and deploying cell and molecular biology test methods is highly desired.

Responsibilities

Lead the lab activities associated with the qualification and maintenance of critical reagents and reference material.
Work requires performance of assays in a GMP BSL-2 environment.
Train and become qualified to perform additional assay work, as needed, to support future pipelines.
Design, screen, and document PCR primer/probes to be used in qualification of viral vectors as needed.
Support analytical methods through assay optimization and contribute to method qualification and validation activities.
Support continuous process improvement initiatives through optimizations and assay robustness improvements such as introduction of automation tools.
Represent Sarepta to external partners, assisting with tech transfers and review requests as needed.
Support analytical trending through compilation and analysis of data related to critical reagents and reference materials.
Assist broader Analytical Development/Quality Control team with coordination of sample pulls, set downs, and tracking critical reagents.
Support troubleshooting activities as a SME for Laboratory Investigations and deviations.
Create and maintain clear and concise records and documentation.
Assist in writing and reviewing quality documents such as SOP, CAPA and Change Control originated internally as well as at the vendor sites.
Perform other related duties incidental to the work described.