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Senior/Principal Scientist, Bioanalytical Assay Development in Cambridge, MA US at Apex Systems

Company: Apex Systems Inc.
Location: Cambridge
Posted on: April 6, 2021

Job Description:

  • Senior/Principal Scientist, Bioanalytical Assay Development Senior/Principal Scientist, Bioanalytical Assay Development in Cambridge, MA US at Apex Systems Senior or Principal Scientist: Bioanalytical Assay Development 1097432-- Job Scope and Purpose:-- Our client 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. 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. We are currently seeking an experienced bioanalytical scientist to join their rapidly growing team. Primary Job 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. Primary Job Requirements:
      • 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. About Stratacuity: Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.
        PROVEN SCIENTIFIC PLACEMENT--- Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us. Code: DiscDevt EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystemsinc.com or 844-463-6178. Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at employeeservices@apexsystems.com (Do not submit resumes or solicit consultants to this email address) or 844-463-6178. Join our Talent Network!

Keywords: Apex Systems Inc., Cambridge , Senior/Principal Scientist, Bioanalytical Assay Development in Cambridge, MA US at Apex Systems, Other , Cambridge, Massachusetts

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