- Participate in the design, development, validation, and implementation of cell based and non-cell-based assays to support bioanalytical and clinical development of Synthekine's therapeutic biologicals and cell therapy drug products.
- Design, develop, troubleshoot, qualify, and implement various bioanalytical ligand binding assays, flow cytometry, single cell omics (CITE-Seq), and biomarker assays for novel drug products to support nonclinical and clinical studies.
- Responsible for development and qualification and troubleshooting of high complexity multiparameter flow cytometry assays.
- Conducts testing of clinical samples including, flow cytometry, and single cell analysis (CITE-Seq) to support clinical immune monitoring programs.
- Stay current and comply with regulatory standards, requirements, guidance, and industry's best practices for GLP/GCLP-compliant bioanalytical PK/PD assays.
- Ensures lab maintenance activities, assist with equipment installation, calibration, usage logs and maintains a clean and safe lab environment
- Analyze, document and report laboratory data in accordance with Synthekine's standards and procedures
- Maintain detailed and well-organized electronic lab notebook and record all experimental details thoroughly and accurately for compliance purposes using Good Documentation Practices
- Communicate experimental findings accurately and concisely in both oral and written form. Authorship of bioanalytical methods (SOPs) and reports.
- Actively participate in presentations of lab data and scientific discussions in lab meetings
- Advanced degree in Cell Biology, Immunology, Biochemistry, or similar fields with minimum of 0-2 years post-graduate experience (persons with BS degree who have comparable depth and breadth of training and experience and who meet job-specific criteria are eligible for consideration)
- Experience in the analysis of flow cytometry data and acquainted with various cytometry data analysis software preferred
- Experienced in primary cell culture and cell-based potency assays, including but not limited to EliSpot and NAb immunogenicity assays.
- Prior experience in flow cytometry assay development, optimization, qualification, validation, troubleshooting, is essential with familiarity of current regulatory guidance and industry best practice
- Design, develop, and execute new flow cytometry panels for high complexity flow cytometry assays. Conduct FACS assay validation studies for clinical programs
- Prior experience in NAb assay development, qualification, and validation is a major plus
- Strong written and oral communications skills, with demonstrated experience in cross-functional and timely communications
- Strong and collaborative work ethic; must be a self-starter and persistent in achieving objectives to support Synthekine's scientific and business goals
- Must work well in a small team setting, with ability to work independently and collaboratively, while meeting scheduled deadlines in a fast-paced environment
- Highly organized, exceptional attention to detail, and strong proficiency in documentation skills
- A passion for teaching and mentoring a major plus
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Scientist I, Translational and Bioanalytical Sciences - Menlo Park, United States - Synthekine
2 weeks ago
Description
Synthekine is a Menlo Park, CA based biotechnology company focused on discovering and developing best in class cytokine therapeutics to treat cancer and autoimmunity. We use our unique insights on how cytokines bind to their receptors and tune these systems though protein engineering to generate therapeutics that have transformative potential. Synthekine was formed in 2019 and has raised $290M from leading biotech investors. We are advancing a deep pipeline of therapeutics against some of the most important cytokine targets. Come join us and help us give patients and physicians better options to treat disease and advance cytokine science along the way.
Position Summary:
We are looking for a talented & driven development scientist to play a key role in the development and execution of product specific bioanalytical assays for Synthekine's various programs. Relevant assays will include, ELISA, MSD, Flow Cytometry, Neutralization Antibody (NAb) assays, qPCR, ddPCR and other novel cell based and non-cell-based bioassays that may be required. The development scientist will play a crucial role in execution of PK/PD assays of both clinical and research drug candidates. The development scientist may also be responsible for mentoring junior analysts.
Responsibilities:
Qualifications:
The anticipated salary range for the position based in our Menlo Park, CA office is $106,000-$128,500. The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience within the job, type, and length of experience within the industry, education, etc. Synthekine is a multi-state employer, and this salary range may not reflect positions that work in other states. We comply with all state, federal and local laws regarding pay practices.
Synthekine requires all new hires to be fully vaccinated prior to the first date of employment (subject to any legally required exemptions).
Synthekine is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
