Sr. Scientist Bioassay

The Senior Scientist will be part of the Critical Reagents group, supporting the development and execution of critical reagent identification and qualification strategy for cell-based bioassay and ELISA methods in alignment with current health authority expectations. This position requires a strong scientific and laboratory background with a focus on potency assay technical strategy and execution.

Job responsibilities include but are not limited to:

• Employ strong technical understanding of the use and assessment of biologic critical reagents to oversee the qualification and stability of these materials.
• Utilize strong collaboration and communication skills to work with analytical, quality assurance, and regulatory colleagues to optimize qualification processes based on current health authority expectations.
• Generate procedures to capture requirements for the qualification and control of biologic critical reagents.
• Prepare technical documentations as required.
• Mentor junior team members as appropriate.

Responsibilities

• Support the identification, qualification, and control of new and existing potency (cell-based and ELISA) critical reagents for programs at various phases of development.
• Author or revise procedures and other documentation to ensure the implementation and execution of sound critical reagent qualification and control in strategy in adherence to health authority expectations and best practices
• Technical and process troubleshooting and finding suitable resolutions.

• Participate in cross functional teams to improve and optimize critical reagent qualification and control processes.
• Work with analytical partners and Critical Reagent Lead to implement best practice and efficiencies for critical reagent strategy

• Stay current with all required lab safety and compliance training.

Education and Experience Requirements

• M.S./ Ph.D. with 3 years of experience, or B.S with 6 or more years of experience in a relevant field required.
• Knowledge and experience with regulatory requirements for GLP/GMP.
• Experience working with biological analytical methods, specifically cell-based bioassay and ELISAs.
• Familiarity with health authority expectations for control of biologic critical reagents
• Experience working with cross functional teams in process and strategy improvement.
• Experience interacting with health authorities and responding to health authority queries a plus.

Key Skills, Abilities, and Competencies

• Excellent organizational, attention to detail, and multi-tasking skills are required.
• Excellent interpersonal, writing, and verbal communication skills are required.
• Strong understanding of cell-based bioassay and ELISA methodology.
• Ability to work efficiently in a GMP environment while exercising judgement within defined procedures/practices to determine appropriate action
• Flexible, and comfortable with a fast-paced and evolving business environment

Complexity and Problem Solving

• Self-motivated, flexible, and willing to adapt to shifting priorities.
• Strong attention to detail and the ability to meet deadlines.
• Strong critical thinking skills to discern potential solutions to complex challenges.
• Inter and Intra-team collaborations to support gene therapy programs.
• Must be comfortable in the fast-paced work environment and interact with cross functional teams.

Internal and External Contacts

• This position reports to, and is directed by, the Critical Reagent Lead.
• This position will support the qualification and control of biologic critical reagents.
• This position will acquire training from QC Operations personnel as needed.
• This position will collaborate with analytical method SME’s on critical reagent identification, qualification, and strategy implementation.

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.

Nearest Major Market: Philadelphia

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.