Director Regulated Bioanalysis

Director Regulated BioanalysisDate: Nov 12, 2024Location: Philadelphia, PA, US, 19104Company: Spark TherapeuticsJoin the Spark TeamWe were born of innovation, springing from the curiosity, imagination and dedication of remarkable scientists and healthcare visionaries. Our shared mission is to unlock the power of gene therapy to accelerate healthcare transformation.We don’t follow footsteps. We create the path.As a member of the Translational and Bioanalytical Sciences (TBS) department, the Director of Regulated Bioanalysis will direct the Regulated Bioanalysis team tasked with the development, optimization and validation of ligand binding assays to detect and quantify biotherapeutics, biomarkers, anti-drug antibodies (ADA) in biological matrices and cell-based neutralizing antibody (NAb) assays along with sample analysis in support of pre-clinical, non-clinical and clinical gene therapy products. The candidate will be a technical expert on assay development for GLP and non-GLP studies, have expert knowledge of the regulatory guidance’s on assay development and sample analyses as well as serve as a scientific expert on projects. The incumbent will utilize leadership skills to supervise a team and manage the professional development of the group. They will work with external partners (CROs) as needed to transfer internal assays and provide guidance, troubleshooting and quality oversight. The successful candidate will interface with project teams to develop, implement and execute the assay strategy from discovery through development. The candidate will also participate in clinical study design and clinical study reports. In addition, this individual will contribute to and author relevant regulatory submission document (pre-IND, IND, IB, BLA, etc.) and present assay strategy and data at internal meetings andrepresent Spark externally in bioanalytical networks of excellence.Responsibilities30% of time-Manage regulated bioanalysis 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.

50% of time-Provide strategic and scientific leadership to the bioanalysis teams responsible for assay development and qualification/validation as well as pre-clinical, non-clinical and clinical sample analysis while ensuring compliance with regulatory guidelines.10% of time-Author, review and approve regulated bioanalysis related content of regulatory documents (includingpre-IND,IND, IB, BLA, etc.).10% of time- Provide scientific and strategic input in the evaluation of new technologies and over-sight of outsourced bioanalytical assays at CROsRequirements

Ph.D. in Immunology, Neuroscience or related field required.

10+ years of industry experience in bioanalytical and immunogenicity assay development for biologics and/or gene therapy products preferred. Industry experience in translational neuroscience is a strong plus.

3+ year management experience

Previous experience as a leader of bioanalytical and immunogenicity assays in a regulated environment

Competencies

Experienced and proficient in the optimization and validation of assays, both ligand binding assays to detect and quantify biotherapeutics, biomarkers, anti-drug antibodies and cell-based immunoassays, including ELISpot and/or Fluorospot .

Working knowledge of GLP, GCP, SOPs and regulatory guidelines related to bioanalyte and immunogenicity assessment

AAV gene therapy experience desired

Demonstrated scientific knowledge and abilities to achieve high barrier scientific goals

Excellent communication skills with the proven ability to work effectively as a member of a multidisciplinary team

Continuously drives scientific and technological innovation

Experienced people manager who leads by example

Able to work collaboratively in a multi-cultural fast-paced environment with ability to handle multiple tasks, and set priorities to meet study timelines

Spark takes into consideration a combination of candidate’s education, training, and experience as well as the position’s scope and complexity, the discretion and latitude required in the role, and external market and internal value when determining a salary for potential new employees. The base salary range for this position is currently from $187,100 to $280,700.Spark Therapeutics does not accept unsolicited resumes/candidate profiles from any source other than directly from candidates. Any unsolicited resume/candidate profile submitted through our website or to personal email accounts of employees of Spark Therapeutics are considered property of Spark Therapeutics and are not subject to payment of agency fees.Nearest Major Market: PhiladelphiaSpark Therapeutics is an equal opportunity employer. We do not discriminate on the basis of race, color, gender, gender identity, sexual orientation, age, religion, national or ethnic origin, disability, protected veteran status or any other basis protected by applicable law. In addition, Spark Therapeutics provides reasonable accommodation to qualified individuals with disabilities and those with a physical or mental condition related, affected by, or arising out of pregnancy, childbirth, or a related medical condition. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment. Applicants or employees who may require such a reasonable accommodation to apply or interview for a job or to perform your job should reach out to HRQuestions@sparktx.com.