Associate Director, Gene Therapy Quality Control Operations
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Job Location:
Andover, KS - USA
Yearly Salary:
$ 160800 - 201000
Posted on:
12 hours ago
Vacancies:
1 Vacancy
Job Summary
Why Sarepta Why Now
The promise of genetic medicine has arrived and Sarepta is at the forefront. We hold a leadership position in Duchenne muscular dystrophy (Duchenne) and are building a robust portfolio of programs across muscle central nervous system and cardiac 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
Were looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and work-life resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits see our website: Importance of the Role
Reporting to the Sr. Director of QC Operations the Associate Director of QC operations is responsible for supporting the operations of the internal ddPCR qPCR and Cell-based assays. The individual will be responsible for supporting all aspects of the laboratory and facility footprint including safety compliance instrumentation and equipment qualification and maintenance. Prior experience with laboratory expansion projects is beneficial. This role is responsible for inventory management raw material procurement as well as the qualification and bridging of critical reagents needed to support internal and external testing at our CMO/CTL partners. The Associate Director of QC Ops is responsible for the supervision of laboratory ops personnel and the optimization of department resource allocation according to project/program needs to assure activities occur in an efficient safe timely and cGMP compliant manner.The Opportunity to Make a Difference
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
More about You
- MS/BS in Molecular Biology Biochemistry Chemistry with 8 years relevant industry experience
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.
What Now
Were always looking for solution-oriented critical thinkers.
So if youre comfortable with ambiguity and candor relish challenging yourself and place kindness and integrity at the forefront of how you approach your peers and work then we encourage you to apply.
Required Experience:
Director
Key Skills
- Business
- Information Management
- Accounting
- Corporate Risk Management
- Faculty
- Jms
About Company
We are focused on the development of precision genetic medicines to treat rare neuromuscular and central nervous system diseases. Learn more about Sarepta.
