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Job Location: Philadelphia, PA
This role will be responsible for developing and directing the bioassay and cell culture analytical support team within the Technical Operations Analytical Sciences organization at Spark Therapeutics facility in Philadelphia, PA.
The primary goals of Analytical Sciences are: to lead the phase-appropriate optimization, qualification, verification and validation of analytical methods across the product development lifecycle from clinical to commercialization; provide support to QC in the investigation of non-conformances, invalid assays; and troubleshooting method problems.
Analytical sciences will also be responsible for developing and overseeing a critical reagents management program, the reference standard program, periodic review of analytical methods, and method performance trending and monitoring.
The position is responsible for leading and developing a team of two scientists specializing in the analytical testing areas of bioassay and cell cultures. The role will support the organizational goals above, as well as perform technical nature as determined by business needs.
25% Develop and execute protocols for phase-appropriate method validation in support of Sparks clinical pipeline.
15% Hire, manage and develop Analytical Sciences team members.
15% Provide direct support to QC Operations in terms of assay troubleshooting and non-conformance investigations.
25% Develop procedures for qualification of critical reagents. Oversee the qualification of new critical reagents to ensure proper assay control. Resolve technical issues arising with critical reagents for bioassay and cell culture.
10% Interface with R&D on the development of new analytical methods for Quality Control, and oversee the creation and/or implementation of these methods in support of Sparks clinical development pipeline.
10% Perform method trending for bioassays and cell cultures and assisting the overall development of an on-going trending program and periodic review of analytical methods.
The successful candidate must demonstrate the following:
Ability to develop solutions to a variety of problems of moderate scope and complexity exercising judgment within defined procedures and practices to determine appropriate action
Strong scientific and technical skills
Strong written and oral communication skills
The Interpersonal skills and knowledge to enable successful interface and collaboration with partner groups in R&D
Ability to be successful in a fast-paced and evolving business environment
The position requires the following, with respect Problem Solving:
The knowledge and ability to evaluate analytical methods against current guidance and industry standards in development, control and performance, and defend such decisions to a regulatory agency.
The ability to solve complex technical problems arising from non-conformances in cGMP test results in a timely yet thorough manner while taking into consideration compliance requirements
This position will advise the Analytical Sciences Lead, Head of Quality Control, and the Spark management team regarding technical and analytical matters.
The position will also direct method development and validation activities being conducted at external contract testing laboratories (CTLs).
The position will also direct and mentor her/his own staff.
The position will interface heavily with R&D, Regulatory Affairs, and Project management in the development of new products and new analytical methods.
Some travel, evening, and weekend hours may be required
M.S. degree in the biological, biochemical or related sciences with a minimum of 5-8 years experience in the Bio/Pharmaceutical industry.
Working knowledge of vaccines, and working knowledge of virology and virus-based assays.
Expertise in cell culture and bioassays.
Prior experience working in either a clinical development or commercial cGMP environment.
Proven experience successfully leading teams
A strong understanding of cGMPs and QC in both commercial and clinical development environments
WHO WE ARE:
Transforming Patients 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.
How To Apply:
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