QC Stability & Specifications Lead

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, maintain, and continuously seek areas of improvement for the specification program with collaboration with Analytical Program Management team

• Expansion of the QC stability program and role function to include generation of release and characterization protocols
• Establish and maintain specifications for products across early phase to commercial.
• Serve as Subject Matter Expert and key functional lead for specification review board meetings.
• Revise specifications to ensure regulatory requirements are met.
• Continuously enhance stability program.
• Support LIMS implementation and enhancement of stability module
• 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

% of Time

Job Function and Description

30%

• 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%

• 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%

• 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.
• Prefer experience with LIMS systems and implementation.
• Generate protocols and overall support of the function -- develop the processes and generation of release and characterization protocols
• 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.

Key Skills, Abilities, and Competencies

• Possess great interpersonal and communication skills.

• Possess excellent skills on prioritizing and time management.

• Highly motivated and detail oriented with good organizational skills.

• Possess the ability to multitask and work independently or in a team environment with minimum supervision.

• Proven analytical aptitude, critical thinking skills and ability to apply key concepts.

Complexity and Problem Solving

• Develop solutions to a variety of problems of moderate scope and complexity.
• Ability to build productive working relationships internally and externally.
• The incumbent must have the experience, knowledge and aptitude to advise management on the design of stability studies in the newly-evolving field of commercial and clinical gene therapy while taking into consideration elements unique the company’s product development programs, as well as analyze, interpret, and trend stability data. .
• The incumbent must have the experience, knowledge and aptitude to advise management on overall specification strategy.

Internal and External Contacts

• Frequent internal and external contacts. Represents organization on specific projects.
• The position advises the QC leader team on matters related to stability and specification.

Other Job Requirements

• May need some travel and weekend work

Please be aware that Spark mandates COVID-19 vaccination of all employees regardless of work location.  Accommodations may be made in accordance with applicable law.