QC Analyst, Bio-Analytical

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 unlock the power of gene therapy to accelerate healthcare transformation.

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

Primary Duties

The Quality Control Analyst will be responsible for conducting validation, routine testing and GMP review of analytical assays in compliance with all applicable quality systems and current cGMPs within the Quality Control department at Spark Therapeutics' facility in Philadelphia, PA. They will support the departmental goals and contribute to general operations and analytical testing within the QC laboratory.

The primary goals of Quality Control are: to lead the execution of release and stability testing for commercial and late phase clinical GMP, execute assay validation and assay transfer studies and critical reagent qualification studies; the implementation and maintenance of laboratory control procedures and compliance; and laboratory investigations.

Responsibilities

• Execute and review of Bio-Analytical assays for release and stability purposes in a GMP-compliant QC laboratory.
• Performs quantitative analytical assays and is experienced with the associated method and instrumentation.
• Executes method validation and transfer studies, as assigned by Functional Manager
• May provide training to other QC analysts.
• Participate in maintaining laboratory systems, equipment and controls. Active in maintaining the compliance of the laboratory.
• Author GMP documents such as analytical methods/forms, technical protocols/reports, CAPAs, and change controls.
• With supervision, complete deviation reports and investigations.
• Conduct wide variety of assays or tests required to characterize and qualify assay-specific reagents.
• Attend team meetings and project meetings with members from QC.
• With guidance, assist during regulatory audits for their respective assays and interact with regulatory auditors.

Education and Experience Requirements

• BA/BS required; and minimum of 2-5+ years related experience -OR- MS/Ph.D. and a minimum of 1-3+ years related experience.
• Experience working in a GMP environment is necessary.
• Strong background experience in executing and troubleshooting HPLC, UPLC and CE-SDS Assays, required.
• Must have experience with Empower and 32Karat Software.
• Hands on experience in executing the following assays, qPCR, PCR, mammalian cell culture techniques, tissue-cultured assays, ELISAs, SDS-PAGE and Western blots, preferred.
• Must have an understanding of the science related to the assays they perform.
• Possess good interpersonal and strong written/verbal communication skills.
• Critical thinking skill, ability to manage time, and skills in prioritizing, organization and time management.
• Highly motivated and detail oriented with good organizational skills.
• Ability to work with minimal supervision; work is reviewed for soundness of judgment and overall adequacy and accuracy.
• May need to be available for some weekend scheduled work.

Spark takes into consideration a combination of candidate's education, training, and experience as well as the position's scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees. The base salary range for this position is currently from $65,300 to $97,900.

Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.