The Bioanalytical Study Lead will be a member of the Translational Bioanalytical Group (TBG) and will direct a team (2-4 scientists/associates) supporting the development of novel gene therapy programs across all Therapeutic Areas. This position requires a strong background and direct hands-on experience in conducting assay transfers, technical troubleshooting, bioanalytical method qualification and validation, data analysis and interpretation, and biological sample analysis. The Bioanalytical Study Lead and their team will work in a GLP environment to perform GLP/GCP compliant methods and sample testing.
The candidate will be responsible to:
Job Function and Description
- Lead a team within TBG and direct operational processes, including but not limited to acquisition and documentation of reagents, preparation of assay plans, protocol, and report, data analysis, review, and interpretation, technical troubleshooting, and support biological sample testing for assigned pipelines
- Apply their hands-on technical expertise of immunoassays, enzymatic activity assays, and anti-drug antibody (ADA) assays along with regulatory guidance expectations to support preclinical and clinical assay readiness and sample testing
- Serve as the responsible scientist for bioanalytical assays assigned and as needed perform bioanalytical assays (specifically ELISA, enzymatic activity, ADA) to support workflow and transfer in of assigned assays
- Use ELN to manage sample inventory, reagent inventory, assay conduct, and derived bioanalytical data
- Effectively communicate results 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 from internal TBG Leads for qualification, validation, and sample testing phase
- Review and approve test method SOPs, bioanalytical assay plans and reports, other technical documents required for study reconstruction
- 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.
Education and Experience Requirements
- Hands on work to prepare and conduct bioanalytical assays for transfer, 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
- Establish schedules, assignments, and timelines for team to meet team objectives
- Interact with key stakeholders (Therapeutic Areas, Quality Control, Quality Assurance) to improve processes and meet objectives
- Oversee CRO outsourced bioanalytical assay qualification, validation, and sample analysis for assigned programs
- Review and approve SOPs, validation/qualification/testing protocols, amendments, deviations, memos, reports, and sample analysis reports
Key Skills, Abilities, and Competencies
- 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 assays 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 hands-on experience with assay development desired
- Previous experience in gene therapy is a plus
The position requires adaptability, excellent planning, organization, and communication skills as well as the ability to work in a fast-paced, team-oriented, multidisciplinary environment. Extensive hands‑on experience in bioanalytical qualification, validation, and sample testing in regulated environment is essential as is the ability to effectively manage performance and talent.
Internal and External Contacts
Therapeutic Areas, Quality Control, Quality Assurance, Laboratory Operations, other Translational Immunology and Bioanalytics groups.
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.
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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.
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