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Assay Development Leader
Job Opportunity at
Spark Therapeutics, Inc
Posted on Jul 2
As a member of the Translational Research Leadership Team, oversees the development, qualification and validation for assays in support of Spark pipeline. In addition to these activities the incumbent may be a member of program teams and applies technical/scientific expertise to contribute/resolve issues regarding the preclinical components of various internal and regulatory documents. The incumbent is also responsible for facilitating communication and technology transfer between a molecular assay development team and the clinical testing group. The incumbent is responsible for ensuring that all work is to be done in a compliant manner according to relevant SOP guidelines and GCLP and/or CGMP guidelines, when required
The incumbent is accountable to the Chief Scientific Officer and serves as a key collaborator and peer to Research Therapy Area Leaders.
Oversee the design, development, qualification and validation of assays in support of pre-clinical studies and clinical trials.
Collaborate as necessary with the appropriate leaders/scientists within Research and Development to determine types of assays to develop and suitable markers for use in a variety of diagnostic assays.
Coordinate development and execution of immune assays and molecular biology assays for the R&D team.
Lead immunology studies in collaboration with other Translational team member.
Interact with intra- and interdepartmental personnel in scientific discussions for assay development or improvements.
Write and review reports, technical documents and presentations to support assay development, qualification, validation and transfer as appropriate.
Establish a diagnostic testing laboratory and ensure compliance according to SOPs and GLP guidelines.
Provide work assignments to teams on a regular basis. Review and approve the work performed by other analysts. Ensure work is done in a compliant manner according to SOPs and GLP guidelines.
Keep abreast of new scientific/ technology development by participating in scientific meetings/ seminars and through regular scientific review.
Present scientific findings and developed technologies in meetings and publish relevant articles in scientific journals.
Participate and lead in developing new technologies and establishing those technologies to characterize gene based products in terms of safety (immunogenicity) and efficacy.
. 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. Hold 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 periodically reviewing individual objectives to ensure alignment to corporate and functional objectives, making adjustments if priorities have shifted.
Develop team members.
Help employees effectively assimilate to Spark and continually grow through challenging experiences so they can realize their full potential. Understand your employee’s goals, strengths and motivators. Partner with your employees to identify areas for development, conduct coaching conversations regularly and provide guidance on ways to develop through on the job experiential learning, social networks and development opportunities.
Foster Spark’s Culture, Mission, Vision, and Values:
Lead by example. Create an environment where team members thrive in our Culture 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.
A strong background in molecular biology and immunology preferred
Expertise in development of immune and molecular assays preferred
Proficiency with personal computers including word processing, spreadsheets, PowerPoint and relevant scientific software is required
Experience in managing CROs is preferred
Experience in AAV gene therapy preferred
Experience in human immunology preferred
Strong background in gene therapy and immunology and in the development of cell-based assay is preferred
Ph.D. in Molecular Biology or related field required
Generally has 12 years of post-graduate experience with at least 5 years of experience leading teams
WHO WE ARE:
Transforming Patient’s Lives. Spark Therapeutics is a pioneering gene therapy leader transforming the lives of patients suffering from debilitating genetic diseases by developing one-time, life-altering treatments. We are embarking on our goal to deliver the first approved gene therapy product in the US for genetic blinding conditions and have a product pipeline addressing other unmet rare genetic diseases. We have an entrepreneurial culture and are looking for talented and passionate professionals who are committed and motivated to making a difference in the lives of our patients. If you share our passion for excellence and are looking for a dynamic work environment that fosters creativity, scientific innovation and team collaboration, you may be a great fit for our team.
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