Senior or Principal Scientist, Bioanalytical Assay Development

Cancer immunotherapy targeting immune checkpoints is demonstrating transformative anti-tumor activity in clinical use, and additional immune regulatory pathways are emerging with the expectation that therapeutics targeting these pathways will rapidly enter clinical development. Werewolf Therapeutics is an exciting start-up biotech, located in the heart of Cambridge MA, focusing on the development of novel biologic agents for the treatment of cancer. We are currently seeking an experienced bioanalytical scientist to join our rapidly growing team.

Description of Role, Responsibilities and Requirements

The successful candidate will be a creative scientist with strong problem-solving skills and demonstrated experience in bioanalytical assay development. H/she will be responsible for the development and qualification of novel assays to quantify the amount and activity of our innovative biotherapeutics. H/she will be required to design, execute and provide data analysis for in vitro and cell-based bioanalytical assays, as well as present the data to the project team and senior management. H/she will be expected to thrive in a dynamic start-up environment.

Responsibilities

• Independently design, develop, troubleshoot, qualify and implement various bioanalytical assays such as PK, PD, ADA, biodistribution, immunogenicity and biomarker assays to support nonclinical and clinical studies.
• Implement new in vitro and cell-based assays using ELISA, AlphaLISA, Luminex, Jess (Proteinsimple) protein analysis, cell-based activity, proliferation and potency assays, ligand-binding assays, qPCR, and various other platforms.
• Evaluate functionality of various bioanalytical assays in different biological matrices (mouse, NHP, human) for analysis of non-GLP studies.
• Advise preclinical team on selection and use of various bioanalytical assay platforms suitable for regulatory filings of novel biologics.
• Use external CRO resources to develop, troubleshoot and execute study and lead efforts to transfer bioanalytical assays once qualified to external CROs.
• Stay current and comply with regulatory standards, requirements, guidance and industry's best practices for GLP-compliant bioanalytical PK/PD assays.
• Perform statistical analysis of experimental data from in vitro and cell-based bioanalytical studies.
• Maintain detailed and well-organized electronic lab notebook.
• Actively participate in presentations of lab data and scientific discussions in lab meetings.

Requirements

• A Ph.D. in Cell and/or Molecular Biology, Pharmacology, Immunology or related disciplines.
• 5+ years of industrial or postdoctoral laboratory experience working in a cancer, immunology or bioanalytical laboratory.
• Extensive technical and hands-on experience with bioanalytical assays for non-GLP/GLP studies.
• Familiarity with industry's best practices in bioanalytical assay development for qualification of PK, PD, ADA, immunogenicity and biomarker assays.
• Strong expertise in cellular tumor immunology, immune checkpoints and T cell/NK biology is a plus.
• Strong analytical and data analysis skills are required.
• Excellent problem-solving skills for developing creative solutions and for maintaining timelines with strong organizational skills.
• Expertise with data processing and analysis tools, Word, Excel, PowerPoint, and Prism.
• Strong written and oral communication skills are a must. Demonstrated ability to work as part of a team to execute experimental plans and deliver results is also necessary.