Immunogenicity Team Lead

Primary Duties

As a member of the Bioanalytics Team, the Immunogenicity Team Lead will oversee the execution, quality and timelines of immunogenicity assays in support of pre-clinical and clinical studies for gene therapy programs in a regulated environment. The incumbent will manage a team tasked with the development, validation and implementation of ligand-binding and cell-based assays to detect the presence of anti-product binding and neutralizing antibodies. S/he will supervise the activities of junior staff members, guiding them in the design and interpretation of experiments. The successful candidate will perform data analysis and interpretation and author reports and protocols. S/he will be responsible for the transfer of data to inter-departmental partners and for facilitating communication and technology transfer between Spark and CROs. The successful 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, cost effectiveness and appropriateness of assays for regulated support.

Responsibilities

% of Time

Job Function and Description

20

Manage immunoassay 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.

30

Oversee the development, validation and implementation of immunoassays in support of pre-clinical and clinical studies.

30

Analyze scientific data, write and review reports, technical documents and presentations to support assay development, validation and transfer to external partners as appropriate.

10

Provide work assignments to the team on a regular basis. Review and approve the work performed by other analysts. Ensure work is done in a compliant manner according to SOPs and GLP guidelines.

10

Stay informed of new scientific/technology development by participating in external scientific conferences and through regular scientific literature review.

Education and Experience Requirements

• Ph.D. or Master's degree in Immunology or related field is required
• Generally has 6 years of relevant post-graduate experience

• Previous personnel management experience is required

Key Skills, Abilities, and Competencies

• A strong background in immunology or related field
• Experience with gene therapy highly desired
• Hands-on experience with bioanalytical and specifically 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
• Excellent judgment and creative problem-solving skills, including negotiation and conflict resolution skills