We are seeking a driven and highly motivated Senior Scientist to join the Translational Medicine department advancing novel vaccine and cell therapies for treatment of cancer. This individual will provide technical and scientific leadership and support for clinical biomarker data using flow cytometry (FACS) and other immunoassays in a regulated setting. Proven track record in bioanalytical sciences, GCP/GLP and good documentation practice is required. The successful candidate should demonstrate broad experimental expertise and a strong work ethic, have excellent communication skills, and work effectively in a highly collaborative cross-functional team environment.
Primary Responsibilities:
- Responsible for providing flow cytometry and other immunoassay data to support clinical studies
- Lead by model supporting translational medicine assay development, assay validation and study execution.
- Responsible for maintaining regulatory compliance appropriate for clinical study data generation and documentation. Subject matter expertise in GLP/GCP guidelines.
- Responsible for SOP development/update, report generation, QC and peer review of raw data and results and participation in audits
- Mentor junior scientists in biomarker strategy development, experimental protocol optimization, troubleshooting, data generation and analysis
- Participate in continuous improvement of scientific and regulatory processes to enhance functional capabilities and productivity
- Effective communications and collaborations across functional lines
Competencies:
- In-depth experience in delivering clinical flow cytometry and ligand binding assay data in the regulated setting
- Strong knowledge in GCP/GLP and regulatory guidelines for assay validation and clinical sample analysis
- Experience in immuno-oncology and cell therapy product development
- Excellent ability to perform hands on experiments, research, design, and organize projects and maintain detailed documentation
- Proven ability to multi-task and embrace change in a fast-paced environment in order to produce quality deliverables for aggressive timelines
- Independently motivated, detail oriented and good problem-solving ability
- Ability to work as part of a team, collaborating and communicating effectively with members of other functional groups
- Ability to analyze data, draw conclusions, communicate results and compile technical reports
Required Skills:
- Proficient in multi-color flow cytometry and other immunoassays (e.g. ligand binding assay, ELISPOT) design and execution
- Skilled in clinical sample analysis, GCP/GLP and documentation compliance
- Experienced in flow cytometry assay validation or ligand binding assay validation
- Excellent oral and written communication skills
- Competent writing, editing and oral presentation skills required
- Must have strong work ethic, organizational and time management skills
- Experienced in managing direct reports
- Strong interpersonal skills and desire to be a member of a team that values open communication
Education Requirements:
- Ph.D. in Immunology or a similar scientific discipline
- Minimum of 5 years of biotherapeutic product development experience in a pharmaceutical or biotech setting
- Or a Master degree with a minimum of 8 years of industry experience in biotherapeutic product development
- Competent writing, editing and oral presentation skills required
- Must have strong work ethic, organizational and time management skills
- Experienced in managing direct reports
- Strong interpersonal skills and desire to be a member of a team that values open communication
Contact Ashley Clark at ashley.clark@genocea.com for more information.
