The Molecular Assay Lead will be a member of the Bioanalytics department, overseeing multiple non-clinical and clinical assays for advancing fast-paced novel gene therapy programs across all Therapeutic Areas. The position requires expert knowledge in molecular bioanalytical and biomarker assay development, including gene copy number, biodistribution and vector shedding, preclinical and clinical sample testing, data analysis and technical troubleshooting.
Responsibilities and expectations include:
Manage the development of multiple molecular analytical assays and preclinical and clinical sample testing efforts simultaneously while directing team members on technical work and interfacing with the therapeutic program leads, ensuring assay requirements are fulfilled within strict timelines.
Apply strong molecular biology and bioanalytical knowledge for developing nucleic acid-based assays to support the preclinical and clinical activities.
Lead experimental design, data analysis and review, prepare results documentations.
Utilize high level of technical expertise and sound judgment for troubleshooting complex molecular biology technical problems and finding appropriate solutions.
Expertise in DNA, RNA, miRNA assays, including DNA/RNA isolation and primer design.
Proficient with qRT-PCR, qPCR, and dPCR methods and skilled in trouble-shooting technical issues.
Experience with high-throughput processing devices such as QuantStudio, QIAsymphony and KingFisher to accommodate large number of sample testing.
Support implementation and utilization of LIMS and Sample Management systems for preclinical assays and tracking sample inventory.
% of Time
Job Function and Description
Manage team members and support the Bioanalytics function to achieve business goals and objectives.
Foster Spark’s Culture. Role model the Spark Values. Create an environment where team members thrive by living our truths, always in compliance with applicable laws and regulations. Emphasize to employees that “how” they achieve performance objectives is just as important as “what” they accomplish.
Hire & Integrate. Know what skills, experiences and capabilities are needed to achieve current and future business goals. Take an active role in attracting and selecting talent who are inspired by our Mission, Vision and Values. Consciously create a team with diverse backgrounds, experiences, skill sets and perspectives. Help new team members successfully integrate into Spark so they can actively contribute and add value as quickly as possible.
Manage performance. Ensure every team member knows what is expected of them, what it takes to be successful, and how they are progressing. Provide team members with continuous and on-going performance feedback, holding everyone accountable to achieve results while demonstrating the Spark Values. Help team members understand how their work contributes to the overall success of Spark by continuously communicating priorities, decisions and changes; adjusting goals as needed.
Develop people. Understand each individual team member’s career goals, strengths and motivators. Partner with employees to identify areas for development, conduct coaching conversations regularly and provide guidance on ways to develop through on the job experiential learning and stretch opportunities.
Lab related activities, including running experiments, data reviews, and participating in process and technology improvement.
Process and technology improvement for increased efficiency and higher capacity
Assist with workflow and manage shifting priorities
Education and Experience Requirements
Ph.D. in a relevant field required.
5+ years molecular assay related experience
Strong knowledge in molecular assay development in biological matrices, data analysis and technical troubleshooting to find suitable solutions.
Extensive experience with biological sample testing, analyzing data and summarizing results in technical documents.
Extensive experience using analytical tools such as SoftMax Pro, Prism and Excel.
Experience with personnel management and workflow coordination.
Knowledge of GLP and regulatory expectations
Experience with gene therapy desired.
Employer will assist with relocation costs.
Internal Number: 1547
About Spark Therapeutics
At Spark Therapeutics, a fully integrated, commercial company committed to discovering, developing and delivering gene therapies, we challenge the inevitability of genetic diseases, including blindness, hemophilia, lysosomal storage disorders and neurodegenerative diseases.Founded in March 2013 as a result of the technology and know-how accumulated over two decades at Children’s Hospital of Philadelphia (CHOP), our investigational therapies have the potential to provide long-lasting effects, dramatically and positively changing the lives of patients with conditions where no, or only palliative, therapies exist. Greater understanding of the human genome and genetic abnormalities have allowed our scientists to tailor investigational therapies to patients suffering from very specific genetic diseases. This approach holds great promise in developing effective treatments to a host of inherited diseases. Our initial focus is on treating orphan diseases.Headquartered in dynamic Philadelphia, we are a diverse, experienced team united in our goal to break down barriers for people and families affected by genetic diseases. As our name suggests, our investigational, one-time therapies are des...igned to spark healthy biology, and deliver potentially life-altering transformation for people and families affected by genetic disease. Spark is a member of the Roche Group.