Bioanalytical Team Lead (Pre-clinical Bioanalytics)

Primary Duties

The Bioanalytical Team Lead will be part of the Pre-clinical Bioanalytics (PCB) group, supporting multiple fast-paced non-clinical studies for advancing novel gene therapy programs across all Therapeutic Areas. The position requires expertise in bioanalytical and immunoassay development, preclinical sample testing, data analysis and technical troubleshooting.

• Lead a sub-team within PCB and manage direct reports for their performance and daily activities, including but not limited to experimental design, data review, and technical troubleshooting.
• Utilize strong bioanalytical expertise for developing various immunoassays such as biomarker, anti-drug antibody, cell-based neutralizing antibody assay (NAb), and enzymatic activity assays to support preclinical studies.
• Utilize strong knowledge of various platforms such as ELISA, MSD-ECL, Gyrolab, Simoa and ProteinSimple to support preclinical studies.
• Utilize expertise of bioanalytical tools such as SoftMax Pro, Gen5 and Prism for data analysis.
• Handle multiple bioanalytical assay development and sample testing efforts simultaneously while maintaining technical excellence and delivering high quality results.
• Effectively collaborate with PCB group members and therapeutic program study leads to ensure bioassay requirements are fulfilled within strict timelines.
• Assist with PCB workflow planning to maximize productivity in the group and reduce rework.
• Help sustain PCB function by increasing capabilities and capacity through scientific innovation and implementing new technologies as required.
• Prepare technical reports as required.
• Support implementation and full utilization of the newer systems such as automation, electronic lab notebook, data management, and LIMS for improving operational processes.
• Champion all aspects of lab safety for ensuring lab operates smoothly and the PCB group follows health and safety regulations.

Responsibilities

Manage team members and support the Pre-Clinical Bioanalytics (PCB) function.

Manage a team within PCB to achieve business goals and objectives.

• Foster Spark’s Culture. Role model the Spark Values. Create an environment where team members thrive by living our truths, always in compliance with applicable laws and regulations. Emphasize to employees that “how” they achieve performance objectives is just as important as “what” they accomplish.
• Hire & Integrate. Know what skills, experiences and capabilities are needed to achieve current and future business goals. Take an active role in attracting and selecting talent who are inspired by our Mission, Vision and Values. Consciously create a team with diverse backgrounds, experiences, skill sets and perspectives. Help new team members successfully integrate into Spark so they can actively contribute and add value as quickly as possible.
• Manage performance. Ensure every team member knows what is expected of them, what it takes to be successful, and how they are progressing. Provide team members with continuous and on-going performance feedback, holding everyone accountable to achieve results while demonstrating the Spark Values. Help team members understand how their work contributes to the overall success of Spark by continuously communicating priorities, decisions and changes; adjusting goals as needed.
• Develop people. Understand each individual team member’s career goals. strengths and motivators. Partner with your employees to identify areas for development, conduct coaching conversations regularly and provide guidance on ways to develop through on the job experiential learning and stretch opportunities.
• Apply best bioanalytical and documentation practices to support bioanalytical assay requirements for advancing gene therapy programs.
• Drive bioanalytical tasks forward at the bench level and direct analysts on their daily workload that includes, but not limited to, experimental planning and execution, data analysis and review, technical troubleshooting, and data reporting.
• Ensure PCB lab runs smoothy while adhering to Spark’s safety rules.

• Assist with PCB workflow planning and execution.
• Help manage shifting priorities at the bench level to fulfill bioassay requirements in timely fashion.

Education and Experience Requirements

• M.S./ Ph.D. in a relevant field is required.
• 5-8 years of strong bioanalytical expertise in immunoassays (such as biomarker, anti-drug antibody, cell-based neutralizing antibody assay, and enzymatic activity assays) is required.
• Expertise in bioanalytical assay development (in biological matrices such as plasma, serum, and tissues) is required.
• Extensive experience in preclinical sample analysis is required.
• Expert level knowledge of various immunoassay platforms (such as ELISA, MSD-ECL, Gyrolab, Simoa, and ProteinSimple) is required.
• Expert level knowledge of various bioanalytical tools (such as SoftMax Pro, Gen5, and Prism) is required.
• Experience managing direct reports for their daily activities and performance is required.
• Experience with workflow coordination is a plus.
• Experience in an industry setting is a plus.
• Experience with gene therapy is desired.

Key Skills, Abilities, and Competencies

• Must be comfortable in the fast-paced work environment.
• Self-motivated, flexible, and willing to adapt to shifting tasks and priorities.
• Ability to collaborate and cooperate with intra/ inter-team stakeholders to meet goals and objectives in strict timelines.
• Excellent interpersonal and communication skills.
• Excellent organizational skills.

Complexity and Problem Solving

• Keen attention to detail.
• Ability to swiftly resolve technical issues and make sound decisions.
• Ability to lead team members through scientific/ technical challenges.
• Ability to work closely with the management and stakeholders to fulfill PCB obligations.

Internal and External Contacts

Research Therapeutic Areas (Liver, CNS, Ocular, Immunology, and Discovery), Developmental Sciences, Bioanalytics & Lab Management, and Pre-clinical Bioanalytics (PCB).

Other Job Requirements

Up to 5% Travel may be required.

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.

Learn more about Spark Therapeutics and view other openings.