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Biological Critical Reagents Lead

Date: Apr 26, 2021

Location: Philadelphia, PA, US

Company: Spark Therapeutics

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.

 

 

Summary

The goal of the critical reagents program is to deliver excellence in the planning, generation, qualification, inventory management and lifecycle management of these key components of analytical methods across the product development continuum.  Spark recognizes that the proper strategy, design, and execution of this responsibility is the lifeline of the analytical activities supporting product development and commercialization, and therefore we are seeking a strong leader with strength in a broad range of skills and knowledge in order to deliver an strategy and function with the science, innovation, excellence in execution that is appropriate for the cutting-edge products we develop and deliver to patients.

 

The Lead will serve as the primary individual responsible for the evolution and oversight of the program and the interface with partners and stakeholders.  The Lead will manage a team of experienced professionals who will execute the function’s primary responsibilities.

 

Responsibilities

Describe the essential daily job functions and include % of time spent on each.

% of Time

Job Function and Description

50%

Leading the design and continuous improvement of the overall critical reagents program.  This includes

  • Seeking input form stakeholders such as Analytical Development, Analytical Sciences, Quality Control and Quality Assurance on program design and maintenance.
  • Authoring of program policies, SOPs, and standards that are phase-appropriate, compliant with regulatory expectations, scientifically strong, and employ the most advanced thinking and innovation.

40%

  • Develop and lead a team of individuals responsible for execution of inventory management, protocol development, oversight, and monitoring of reagent performance and stability.

15%

  • Interface with customers to understand program and department needs, seek scientific input on new reagents, plan resources and activities, report on issues and quality and customer service metrics.

10%

  • Represent the function in any department meetings as requested.    Represent the program in Health Authority Inspections as needed.

 

 

Requirements

  • MS degree in the biological, biochemical or related sciences with generally 10+ years of experience in the Bio/Pharmaceutical industry or a PhD degree in biological, biochemical or relates sciences with generally 5+ years of experience in the Bio/Pharmaceutical industry
  • Experience in the development of analytical methods for biological products
  • Experience in managing clinical or commercial Quality Control testing for biological products
  • Experience working in analytical organizations across multiple phases of product development and commercial manufacturing.
  • Experience managing teams.

 

Competencies

The successful candidate must demonstrate the following:

  • Advanced scientific skills and knowledge related to analytical methods for biological products.
  • Strong problem-solving skills and critical thinking
  • Familiarity with the application of appropriate CMC statistics
  • A strong commitment to, and aptitude for organization and planning
  • Customer-focused mindset, and ability to develop and communicate performance metrics
  • Strong communication skills


Nearest Major Market: Philadelphia