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Analytical Development Leader
Job Opportunity at
Spark Therapeutics, Inc
Posted on Mar 13
The Analytical Development Lead will manage all aspects of gene therapy based product analytical methods development to support Spark’s pipeline of cutting edge recombinant viral vector-based products. They will build on Spark’s pioneering vector analytical strengths through optimization of existing methods, and by development, optimization and validation of new cutting edge methods. They will work in a highly interdiciplinary environment and be expected to communicate effectively and productively with research, development, technical operations, regulatory, quality assurance and other departments as needed to ensure that rigorous scientific, technical and product quality expectations are achieved.
They will be responsible for scientific leadership and management of the analytical development function, developing strategies, leading the design, and ensuring effective execution of protocols and delivery of reports in a timely manner to meet departmental goals. They will be responsible for budgeting relating to design and execution of studies, as discussed with and approved by the chief technology officer. An in-depth understanding of biopharmaceutical requirements for product characterization of innovative biologics, excellent laboratory, organizational, written and oral communications, and a proven ability to work effectively in a team environment are critical to success in this key position.
Overall responsibility for innovation, development, and transfer analytical methods for product characterization and quality control, and participation in troubleshooting of vector product characterization methods.
Build and provide line management oversight and coaching for the Analytical Development Team.
Work closely with discovery research, development, technical operations quality control, quality assurance, and regulatory, identify needs for product charcterization in a product specific and clinical development stage -specific manner, and design and protocols to support rAAV based product analytical methods development; write and execute methods development study protocols and reports
Ensure successful and timely transfer of technology to the Quality Control laboratory of new methods, including written development reports, standard operating procedures, hands on training, and follow up troubleshooting,
Develop and establish stability indicating assays for recombinant AAV vectors, specifically methods to measure quantify critical quality attributes of gene therapy based investigational products that can support product stability assessement.
Innovate, develop and optimize new methods to characterize viral vector products, including bioassays to measure functional the functional activity of gene therapy based investigational products.
Ensure accurate and timely analysis of data, and preparation and submission of development reports. Write relevant sections for regulatory submissions (pre-IND, IND, BLA) consistent with high industry standards for thoroughness, data integrity, clarity, quality assurance and compliance
Maintain complete and accurate laboratory records within the Analytical Methods Development function, and maintain compliance with GLP
Provide written monthly reports to the CTO
Participate in laboratory meetings to present and discuss development experiments
Participate in cross functional area team meetings and participate as a subject matter expert for analytical methods development and investigational product characterization
Perform literature research, complete training and administrative tasks
Accountable for timely completion of work by the analytical methods development team, including commitment to excellence combined with a sense of urgency
Participate in multidisciplinary project teams, providing subject matter expertise and accountability for performance of formulation studies as part of integrated project plans
Work with a strong commitment to meet corporate goals and timelines
Develop and maintain effective interactions with colleagues (intra and inter departmental) to ensure a productive and professional working environment
Occasional travel may be required, including attendance at relevant science and technology meetings.
Expertise, fundamental understanding and strong laboratory skills with a diverse range of product characterization methods relevant to biologics and gene therapy based investigational products, including cell based assays, bioassays, protein or vector analysis by chromatography (SEC, ion exchange, reverse phase HPLC), spectrophotometry, gel electrophoresis (protein and DNA), ELISA, Western blotting, quantitative PCR, dynamic light scattering, microscopy, sterile cell culture
Demonstrated leadership abilities to support the successful operation of this key area to ensure corporate goals and continued leadership in gene therapy analytical methods
Proven ability to work independently in a hands-on laboratory setting, self-motivated to learn and develop new techniques, perform multiple tasks simultaneously, maintain accurate records, develop procedures, and comply with company policies
Energetic and eager to manage multiple activities and priorities
Dedication to quality in all work tasks and deliverables
Comfortable with responsibilities in an entrepreneurial, fast–paced, start-up company environment
Vector production and purification experience a plus
Excellent oral and written communication skills, including expertise with computer software commonly used in biotech research and development
Strong team player who works closely and effectively with colleagues
Ph.D. in a relevant discipline (biochemistry, cell and molecular biology, molecular virology,)
A minimum of 10 years relevant working experience required
Experience in analytical methods development for viral vectors, vaccines, or other biologics required
Experience with recombinant AAV vectors a plus
Experience in biotechnology or pharmaceutical industry required
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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