• Senior Scientist

    Actalent (Cleveland, OH)


    SENIOR SCIENTIST - IVD PRODUCT DEVELOPMENT

    INTERESTED CANDIDATES MAY SEND UPDATED RESUMES TO: JGASSER @ ACTALENTSERVICES.COM

     

    OR TEXT JENNA TO SETUP A PHONE INTERVIEW: 419. 980. 5823

    Responsibilities:

    + Lead project studies supporting regulatory filings, working on multiple unrelated projects simultaneously

    + Train and mentor junior scientists, fostering a culture of scientific excellence

    + Execute and document product development work under design control and the company’s quality management systems, policies, and procedures

    + Develop and optimize study protocols, ensuring scientific rigor and compliance with CLSI guidelines and regulatory agency requirements

    + Perform complex statistical analyses independently or in coordination with statisticians

    + Interpret experimental results, draw conclusions, and define next steps to achieve project objectives

    + Ensure analyses and result interpretation are accurate and appropriate to support internal reports regulatory submissions, and scientific publications

    + Prepare clear, concise, and professional study reports to support regulatory submissions

    + Develop and deliver data-driven presentations for internal and external stakeholders

    + Create presentations to effectively communicate key research findings and project status

    + Lead technical discussions and project meetings, ensuring alignment with strategic goals

    + Ensure compliance with all safety and company policies, including biosafety and hazardous material handling protocols

    + Extensive technical and managerial expertise in IVD product development

    Skills & Qualifications:

    + Bachelor’s degree in Biology, Biochemistry, Molecular Biology, Biomedical Engineering, or a related field with 16-20 years of relevant experience

    + Master’s degree with 10-15 years of experience

    + Ph.D. with 7-12 years of experience

    + Experienced at creating protocols and reports suitable for regulatory submission

    + Strong understanding of FDA and global regulatory requirements

    + Experience with statistical analysis software (Analyze-It, JMP)

    + Commercial IVD product development experience preferred

    + Demonstrated ability to lead research teams and manage multiple projects effectively

    + Strong data analysis and statistical interpretation skills

    + Ability to troubleshoot complex technical issues and drive problem-solving initiatives

    Pay and Benefits

    The pay range for this position is $100000.00 - $120000.00/yr.

     

    100% Employer-paid medical for single coverage effective on your date of hire and 50% employer-paid medical for spouse/dependent coverage100% Employer-paid Dental & Vision for entire familyNo cost for employee coverage for Group Term Life, Short & Long Term Disability4% retirement contribution Employer matchIncentive Performance Plan & Stock Option Program & Commission (Sales Account Execs)Paid Family Leave ProgramGenerous PTO plan & holiday programFlexible work schedule & lucrative employee referral programSalary range may vary by work state/geographical region/territoryEasy to get to office location with newly built-out office spaceFree coffee, snacks and other goodies all day long

     

    Workplace Type

     

    This is a fully onsite position in Cleveland,OH.

     

    Application Deadline

     

    This position is anticipated to close on May 29, 2025.

    About Actalent

    Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

     

    The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

     

    If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing due to a disability, please email [email protected] (%[email protected]) for other accommodation options.