QC Specification and Stability Lead
Philadelphia, PA 
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Posted 2 days ago
Job Description

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.

Primary Duties

The QC Specification and Stability Lead will oversee the specification program and stability program, as well as initiate and monitor individual stability studies covering Spark's growing pipeline of ground-breaking clinical and commercial therapeutics.

Responsibilities include but not limited to:

  • Lead QC stability and specification team.
  • Develop and maintain specification program.
  • Establish and maintain specifications for products across early phase to commercial. Host specification review board meeting. Revise specifications to ensure regulatory requirements are met.
  • Continuously enhance stability program.
  • Advise QC senior management on the design of stability protocols for INDs/IMPDs, registrational stability and market-life stability protocols.
  • Generate and monitor individual stability study.
  • Author and review out of specifications and invalid test investigations, deviations, CAPAs, and change controls.
  • Analyze, interpret, and trend stability data.
  • Author regulatory submissions
  • Participate in regulatory inspections.
  • Act as SME with respect to the stability and specification programs. Assist with answering of regulatory questions.
  • Author and review SOPs, manage non-conformance events as needed

Responsibilities

30 % of Time

  • Develop recommendations to enhance the Stability Administration program at Spark Therapeutics.
  • Develop and manage individual study protocols.
  • Analyze, interpret, and trend stability data.
  • Organize and present stability data as needed for internal and external needs.
  • Assist with the authoring and reviewing of stability sections in regulatory application.
  • Act as the SME with respect to the stability program. Assist with answering of regulatory questions and participate in regulatory inspections.
  • Author and review out-of-specifications and in-valid test investigations.

40 % of Time

  • Develop and maintain specification program.
  • Establish and maintain specifications for products across early phase to commercial.
  • Manage specification review board meeting.
  • Revise specifications to ensure regulatory requirements are met.
  • Assist with authoring and reviewing of specification sessions in regulatory filling documents.
  • Participate in regulatory inspections.

30 % of Time

  • Manage performance of direct reports, provide continuous and on-going performance feedback, hold team member accountable to achieve results while demonstrating the Spark Values. Ensure individual objectives align to corporate and functional objectives.
  • Develop and coach employees by continually growing employees through challenging experiences. Foster Sparks Culture and lead by example.

Education and Experience Requirements

  • BS degree on biological, chemical sciences, or related discipline, is required. Advance degree is preferred.
  • 8+ years for BS, 5+ years for MS, 3+ years for PhD, of experience with biopharmaceutical products, biologics or vaccines required.
  • Must have GMP experience.
  • Previous supervisory experience is preferred.
  • Scientific knowledge and demonstrated analytical background are preferred.
  • Experience in lab investigation and deviation is required.
  • Experience in managing stability and specification programs is required. Experience in large molecule is preferred.
  • Excellent communication skill is required.
  • May need some travel and weekend work

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Bachelor's Degree
Required Experience
8+ years
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