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PD Analytical Lead

Date: Aug 14, 2019

Location: Philadelphia, PA, US

Company: Spark Therapeutics

Summary

Join the Spark Team

 

We were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to challenge the inevitability of genetic disease by discovering, developing, and delivering treatments in ways unimaginable – until now.

 

We don’t follow footsteps. We create the path.

 

The Analytical Development Lead will develop and manage analytical methods to support Spark’s pipeline of cutting edge recombinant viral vector-based therapies. This individual will lead a team of analytical scientists to build on Spark’s pioneering vector analytical strengths through optimization of existing methods and development of new methods for AAV gene therapies. S/he will work in a highly interdisciplinary environment and be expected to communicate effectively and productively with research, development, technical operations, regulatory, quality, and other departments as needed to ensure that rigorous scientific, technical, and product quality expectations are achieved.

 

 

The Analytical Development Lead will:

  • Lead a team of scientists to develop, qualify, and transfer analytical methods to measure critical quality attributes for AAV gene therapy product release and characterization.
  • Work closely with translational research, other PD functions, technical operations quality control, quality assurance, and regulatory to identify needs for release and characterization assay development.
  • Work closely with project management to establishing project timelines and ensuring work is completed according to schedule. Actively participate in cross-functional meetings to communicate progress.
  • Training and developing staff at varying levels of experience.
  • Ensure successful and timely transfer of technology to the Quality Control laboratory, including written development reports, standard operating procedures, hands on training, and follow up troubleshooting,
  • Participate in technical PD and cross functional area team meetings and participate as a subject matter expert for analytical methods development and investigational product characterization
  • Ensure accurate and timely analysis of data to support preparation and submission of development reports.  Support the responses regulatory agency questions and prepare data for regulatory interactions.
Responsibilities

40%

Identify, develop and qualify new analytical methods for characterization and undersatning of Spark’s AAV based product development,  Design and trouble-shoot experiments based on personal experience and literature review. Prepare and deliver scientific presentations at internal and external meetings

 

20%  

Prioritize projects, plan workload, manage resource and personnel scheduling

 

15%

Author and support regulatory documentation (pre-IND, BLA) to enable key program milestones for Spark’s assets.  Provide feedback on regulatory questions and prepare supporting data and documentation when necessary.

 

15%

Execute experiments on the bench if necessary, and prepare sample analysis reports.  Author and support regulatory documentation (pre-IND, BLA) to enable key program milestones for Spark’s assets.  Provide feedback on regulatory questions and prepare supporting data and documentation when necessary.

 

10%

Provides leadership to team members including managing performance, developing people, hiring and integrating new team members and fostering Spark’s culture, mission, vision and values. 

Requirements
  • Ph.D. in a relevant scientific or engineering discipline (biochemistry, cell and molecular biology, molecular virology, etc)
  • A minimum of 8 years relevant working experience, preferably within an established biotechnology organization in analytical development
  • Experience in analytical methods development for viral vectors or other biologics required
  • Experience with recombinant AAV vectors a plus
  • Experience in managing teams of at least 5-10 scientists a plus
  • Experience with authoring regulatory documents and supporting filings (BLA, EMA, etc.) a plus
  • Experience in biotechnology or pharmaceutical industry required
Competencies
  • Expertise, fundamental understanding and strong laboratory skills with a diverse range of product characterization methods relevant to biologics and gene therapy investigational products, including protein or vector analysis by chromatography (SEC, ion exchange, reverse phase HPLC), spectrophotometry, gel electrophoresis (protein and DNA), dynamic light scattering, microscopy, ELISA, and or Cell cultutre based assays.
  • Demonstrated leadership abilities to support the successful operation of this 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, priorities, and direct reports
  • Strong team player who works closely and effectively with colleagues, strong organizational skills.
  • Excellent writing and verbal communication skills.
  • Demonstrated ability to hire & integrate new talent into the organization, manage performance, develop people, and model the company’s values & culture
  • Strong publication record is a plus.
  • Experience with AAV vectors is a plus.


Nearest Major Market: Philadelphia