Associate Director, Gene Therapy Quality Control Operations
Scorpion Therapeutics, New Bedford, Massachusetts, us, 02746
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Role Summary Associate Director, Gene Therapy Quality Control Operations. Reports to the Sr. Director of QC Operations and leads QC activities for internal ddPCR, qPCR, and cell-based assays, ensuring laboratory safety, compliance, and equipment qualification. Responsible for inventory management, raw material procurement, and reagent qualification for internal and external testing at CMO/CTL partners, and for optimizing department resources to meet program needs in a cGMP setting.
Responsibilities
Manage the inventory for all reference standards, assay controls and critical reagents qualification, bridging, and expiration extension
Generate Certificate of Analysis for critical reagents in compliance with cGMP
Monitoring KPIs associated with laboratory performance, productivity, run time and efficiency
Establish cross-functional relationships with Sarepta CMC stakeholders to aligned goals, timelines, and resource requirements
Establish and manage external collaborations to accomplish key Sarepta objectives
Proactively identify opportunities to improve operational efficiency, communication, and program outcomes
Ensures compliance with GCP, GLP and cGMP guidelines both internally at Sarepta and at contract testing laboratories
Procure new equipment and support timelines for qualification
Support quality events associated with Laboratory investigations, deviations, change controls, etc.
Author regulatory submission sections and address questions from health authorities regarding critical reagents
Manage spend through budget planning, Scope of Work requests, invoice reconciliation, and change orders
Qualifications
Direct working experience in AAV products is highly desired.
Extensive technical expertise with gene expression analysis including qRT-PCR, ddPCR, and immunoassays such as Jess capillary electrophoresis, ELISA, immunoblotting.
Experience operating liquid handlers is beneficial.
Proven ability to balance conflicting priorities across multiple programs, and to make sound recommendations for trade-offs to achieve aligned objectives.
Strong interpersonal skills and a proven ability to communicate effectively through verbal and written formats.
Laboratory expansion experience is beneficial
Self-starter with the ability to work in a fast-paced, cross-functional, highly collaborative environment.
Education
MS/BS in Molecular Biology, Biochemistry, Chemistry with 8+ years relevant industry experience
Additional Requirements
On-site role at a Sarepta facility in the United States
Candidates must be authorized to work in the United States
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Role Summary Associate Director, Gene Therapy Quality Control Operations. Reports to the Sr. Director of QC Operations and leads QC activities for internal ddPCR, qPCR, and cell-based assays, ensuring laboratory safety, compliance, and equipment qualification. Responsible for inventory management, raw material procurement, and reagent qualification for internal and external testing at CMO/CTL partners, and for optimizing department resources to meet program needs in a cGMP setting.
Responsibilities
Manage the inventory for all reference standards, assay controls and critical reagents qualification, bridging, and expiration extension
Generate Certificate of Analysis for critical reagents in compliance with cGMP
Monitoring KPIs associated with laboratory performance, productivity, run time and efficiency
Establish cross-functional relationships with Sarepta CMC stakeholders to aligned goals, timelines, and resource requirements
Establish and manage external collaborations to accomplish key Sarepta objectives
Proactively identify opportunities to improve operational efficiency, communication, and program outcomes
Ensures compliance with GCP, GLP and cGMP guidelines both internally at Sarepta and at contract testing laboratories
Procure new equipment and support timelines for qualification
Support quality events associated with Laboratory investigations, deviations, change controls, etc.
Author regulatory submission sections and address questions from health authorities regarding critical reagents
Manage spend through budget planning, Scope of Work requests, invoice reconciliation, and change orders
Qualifications
Direct working experience in AAV products is highly desired.
Extensive technical expertise with gene expression analysis including qRT-PCR, ddPCR, and immunoassays such as Jess capillary electrophoresis, ELISA, immunoblotting.
Experience operating liquid handlers is beneficial.
Proven ability to balance conflicting priorities across multiple programs, and to make sound recommendations for trade-offs to achieve aligned objectives.
Strong interpersonal skills and a proven ability to communicate effectively through verbal and written formats.
Laboratory expansion experience is beneficial
Self-starter with the ability to work in a fast-paced, cross-functional, highly collaborative environment.
Education
MS/BS in Molecular Biology, Biochemistry, Chemistry with 8+ years relevant industry experience
Additional Requirements
On-site role at a Sarepta facility in the United States
Candidates must be authorized to work in the United States
#J-18808-Ljbffr