• Apex Systems
  • Watertown , MA
  • Scientific Research
  • Full-Time
  • 2 Barnard Ave

Job Description


Senior Scientist, Gene Therapy Bioanalytical Assay Development 954576
Job Scope & Purpose:
Our clients growing team is looking for an experienced Bioanalytical Scientist with enthusiasm and scientific rigor to join their cutting edge Biotech. This person will assume responsibility for qualifying and validating bioanalytical methods to support preclinical and clinical development of novel gene editing therapeutic candidates, including antibody assays, ELISpot, qPCR, RT-PCR, and biomarker quantitation. You will identify/oversee appropriate CRO's to support assay development, validation and sample analysis, as well as work closely with research to transfer and optimize assays for further development. Author, review and finalize bioanalytical reports, relevant sections of IND applications, and responses to regulatory agency questions regarding methods and analysis. If you are passionate about bringing new medicines to patients in need and can meet these requirements, consider applying.
Primary Job Requirements:
  • A minimum of 5 years of relevant pharmaceutical industry experience and a Ph.D. or equivalent in a relevant biological discipline
  • Deep knowledge of bioanalytical assay development, qualification, and validation requirements to comply with current regulatory standards
  • Experience in CRO management and oversight for bioanalytical assay development, validation, and sample analysis
  • Experience in relevant analytical methodology, emerging new technologies, troubleshooting, and problem-solving
  • Working knowledge of Good Laboratory Practices (GLP)
  • Familiarity with gene therapy systems (AAV vectors and/or CRISPR/Cas9)
  • Excellent interpersonal communication and written skills for presentations, report writing, and day-to-day project team communications.

  • 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.
    ...@stratacuity.com
    Code: DiscDevt

    Associated topics: aseptic, health, histology, immunoassay, industrial hygienist, medical, nutritionist, pharmacy, transfection, virus

    * The salary listed in the header is an estimate based on salary data for similar jobs in the same area. Salary or compensation data found in the job description is accurate.

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