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Senior Scientist

Actalent • Cleveland, OH • 3w ago

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 actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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