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Head of Analytical Sciences

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 Head of QC Analytical Sciences will be responsible for developing and directing an analytical and technical services function that works in conjunction with, and directly supports Quality Control Operations at Spark Therapeutics’ facilities in Philadelphia, PA.

 

The overall goal of QC Analytical Sciences is to deliver the strategy, processes and execution for technical activities supporting clinical and commercial quality control testing and associated CMC activities required for INDs/IMPs, BLAs/MAAs and post approval activities.  Responsibilities include phase-appropriate method lifecycle activities such as method optimization, verification and validation, trending of method performance, and the planning and execution of post-validation method changes to reduce risk in operations.    Analytical Sciences provides direct support to QC in the investigation of laboratory non-conformances, troubleshooting of assay issues from a technical perspective, and the design and oversight of laboratory equivalency studies and other CMC analytical activities such as comparability studies.  Analytical sciences will also be responsible for developing and executing a critical reagents management program, the reference standard program, periodic review of analytical methods, and method performance trending and monitoring.

 

In addition to managing the Analytical Sciences team and ensuring execution of its core responsibilities, the Head of Analytical Sciences and key members of the team will participate in CMC project teams and play a key role in advising on technical matters and analytical CMC strategy decisions such as the establishment and evolution of product specifications, reference standard strategy, etc.

 

 

Responsibilities

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

% of Time

Job Function and Description

30%

Oversee the design, establishment, and proper execution of processes and procedures for phase-appropriate lifecycle management of new and existing analytical methods for clinical and commercial product testing.

30%

Partner with and provide direct support to QC Operations in terms of assay troubleshooting, training, laboratory investigations, back-up GMP testing, design, and oversight of special studies such as method transfers and bridging studies and ensuring continuity of testing and reduction in deviations through the proactive monitoring of assays and planning and management of method, equipment and reagent change activities.

20%

Oversee the critical reagents program and inventory to ensure and uninterrupted supply of well qualified reagents to the QC laboratories.  Monitor the performance of critical reagents through data trending to ensure proper method performance and establish and oversee requalification procedures.

20%

Engage and partner with Analytical Development, Regulatory CMC, and Quality in the

development of strategies and plans for CMC analytical activities supporting clinical product development and post approval product lifecycle management.  Advise CMC project teams on analytical CMC strategy and technical matters related analytical methods, specifications, etc.  Author and/or review regulatory communications.

 

 

Requirements

PhD degree in the biological, biochemical, or related sciences with a minimum of 10-12 years’ experience in the Bio/Pharmaceutical industry, with a minimum of 5 years in a supervisory or lead role. Working knowledge of biotech products or vaccines required and working knowledge of virus-based modalities preferred.  Expertise in cell culture and bioassays also desired.  Must have prior experience working in either a clinical development or commercial cGMP environment.

 

 

Competencies

The successful candidate must demonstrate the following:

  • Strong scientific and technical competencies
  • Ability to develop and articulate both high-level and detailed strategies and plans
  • Excellent comprehension of QC laboratory operations.  Direct QC lab management experience preferred.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to and manage changing priorities and deadlines.
  • Proven experience in biological product development from early phase clinical to commercial.  Ideally, the successful candidate should be able to demonstrate direct contributions to analytical strategy and authoring of INDs/IMPDs and BLAs/MAAs.
  • Expert level knowledge of GLP and GMP requirements as they pertain to Quality Control (QC) testing

 

 

 


Nearest Major Market: Philadelphia