As a member of the Bioanalytics Team, the Neutralization Assay Team Lead will oversee the timely method development, validation, and execution of cell-based neutralization assays in support of pre-clinical and clinical studies for gene therapy programs in a regulated environment. The incumbent will manage a team of 3-4 individuals tasked with the implementation of cell-based assays to detect the presence of neutralizing antibodies to viral capsids and transgene proteins. S/he will supervise the activities of junior staff members, delegate work, and guide them in the design and execution of experiments in alignment with current processes. The successful candidate will be highly familiar with bioanalytical concepts, perform assay qualifications or full validation, analyze, and interpret data and author reports and protocols. S/he will be responsible for the transfer of data to inter-departmental partners and will facilitate communication and technology transfer between Spark and CROs. The candidate will interface with Spark project teams and ensure that all work is done in a manner compliant with relevant SOP guidelines and regulatory expectations. S/he will advance bioanalytical capabilities to improve efficiency and cost effectiveness. In addition, the candidate will work closely with the Translational Immunology and Bioanalysis leader to explore and develop novel next generation neutralizing antibody assays.
Manage NAb team 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.
Oversee the development, validation, and implementation of generic and novel neutralization assays in support of pre-clinical and clinical studies.
Analyze scientific data, write, and review SOPs and reports, technical documents, and presentations to support assay development, validation, and transfer to external partners as appropriate. Author technical manuscripts and external presentations.
Provide work assignments to the team on a regular basis. Review and approve the work performed by analysts. Ensure work is done in a compliant manner according to SOPs and GLP guidelines.
Stay informed of new scientific/technology development by participating in external scientific conferences and through regular scientific literature review.
Education and Experience Requirements
Key Skills, Abilities, and Competencies
- Ph.D. in Immunology or related field such as cell biology is required.
- Generally, has 6 years of relevant post-graduate experience in biotech or biopharma.
- Previous personnel management experience is required.
- A strong background in bioanalysis and familiarity with bioanalytical concepts is a must.
Complexity and Problem Solving
- Strong verbal and written communication skills.
- Hands-on experience in cell based NAb and other immunogenicity assays.
- Expertise in development and validation of immunoassays, in particular cell-based neutralizing antibody assays directed at viral capsids and transgene proteins.
- Experience with GLP and GCP regulations.
- Efficiency, organization, and creative problem-solving skills, including negotiation and conflict resolution skills.
- Ability to see the big picture and work independently with minimal supervision.
- Ability to work in a fast-paced environment.
- Experience with gene therapy highly desired.
Internal and External Contacts
- Will handle team issues related to work and processes independently.
- Develops solutions to challenging problems and justifies and communicates path forward with confidence.
- Reaches out to management for guidance at appropriate intervals to enable speedy delivery of data to stakeholders.
The Neutralization Assay Team Lead is accountable to the Translational Immunology and Bioanalysis Leader and serves as a key collaborator with research teams; will work closely with Clinical Operations, Quality Assurance and Sample Management.
Other Job Requirements
Minimal travel required, up to 5%
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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