The Bioanalytical Assay Development Lead will be a member of the Translational Bioanalytical Group (TBG) and will direct an assay development sub-team (2-4 scientists/associates) supporting novel gene therapy programs across all Therapeutic Areas. This position requires a strong background and direct hands-on experience in conducting independent assay development, data analysis, and technical troubleshooting. The Bioanalytical Assay Development Lead and their team will work under “GLP readiness” to assure assays achieve seamless transfer to a GLP environment.
The candidate will be responsible to:
• Lead a team within TBG and direct operational processes, including but not limited to acquisition and/or design of reagents, experimental approach, data analysis, review, and interpretation, technical troubleshooting, and preparation of assay protocols and reports
• Apply their hands-on technical expertise of immunoassays, enzymatic activity assays, and anti-drug antibody assays along with regulatory guidance expectations to support preclinical and clinical assay development and sample testing when applicable
• Serve as the responsible scientist for bioanalytical assays assigned and as needed to perform bioanalytical assays (specifically ELISA, enzymatic activity, ADA) to support workflow
• Use ELN to manage assay development and derived bioanalytical data
• Effectively communicate results, selected methodologies, and status updates to management
• Increase TBG efficiency and capacity through scientific innovation and implementing new technologies and automation in the lab
• Collaborate effectively with other scientists within and outside the group and department
• Collaborate with Therapeutic Area teams to define deliverable requirements
• Transfer robust assays aligned with regulatory guidelines to other internal TBG Leads for qualification, validation, and sample testing phases
• Provide guidance and direction to team on strategic thinking, leadership, and career development to build a strong team
• Demonstrate adaptability, excellent planning and organizational skills, and communication
• Work in a fast-paced, team-oriented, multidisciplinary environment with fluctuating priorities and deadlines
• Champion all aspects of lab safety, ensuring lab operates smoothly and the team follows health and safety regulations
Manage a team within TBG 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
• Hands-on work to prepare and conduct bioanalytical assay development with readiness for GLP qualification, validation, or sample testing for assigned programs
• Train and direct team to perform new procedures and bioanalytical assays
• Identify and resolve technical and analytical issues
• Interact with key stakeholders (Therapeutic Areas, Quality Control, Quality Assurance) to improve processes and meet objectives
• Oversee CRO outsourced bioanalytical assay development
• Review and approve SOPs and other technical documents
Education and Experience Requirements
• Ph.D. or MS in relevant scientific discipline (e.g., biology, biochemistry, cell biology).
• Minimum 5 years (Ph.D.) or 8 years (M.S.) of direct experience with bioanalytical assay development and sample testing required (specifically ELISA, ECL, ADA, enzymatic activity assays, or closely related).
• Previous experience managing others in a bioanalytical laboratory is essential
• Excellent understanding of regulatory guidance on bioanalytical assay validation and biological sample testing as well as GLP expectations for bioanalytical laboratories
• Proficiency using software applications (e.g., LIMS, SoftMax Pro, Gen5, Graph Pad Prism)
• Excellent communication, organization, and attention to detail is essential
• Previous experience in gene therapy is a plus
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.
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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.