• R&d Specialist

    Actalent (Mundelein, IL)


    Job Title: R&D SpecialistJob Description

     

    We are seeking a dedicated R&D Specialist to join our team and contribute to the development of new products and technologies within the R&D group. This role will focus primarily on Laboratory Information Management Systems (LIMS) due to our current system upgrade and the need to review all stability studies. As a subject matter expert in Stability, you will facilitate project needs and help manage a backlog of over 300 studies. The position involves handling non-routine studies, requiring analytical thinking and problem-solving skills for new product-related stability studies.

    Responsibilities

    + Conduct LIMS review of stability studies.

    + Plan and execute or facilitate stability testing to support product claims.

    + Author and review stability protocols and reports.

    + Track, compile, and review results needed for product requirements and regulatory submissions such as 510k’s, CE technical files, and ANDA/NDAs.

    + Compile technical justifications and data summaries to support stability claims.

    + Identify and support the development of product requirements, performance attributes, and quality specifications.

    + Coordinate verification and validation activities.

    + Ensure compliance of data collection activities with regulatory requirements.

    + Participate in internal and external audits support.

    + Compile risk assessments, identify gaps, and propose solutions.

    + Lead or support process improvement, CAPA, OOS investigations, and data trending activities.

    Essential Skills

    + Proficiency in stability studies, technical writing, and report writing.

    + Experience in laboratory settings and familiarity with GMP, GLP, and FDA regulations.

    + Experience with LIMS management and documentation.

    + At least 2 years of experience in medical device or pharmaceutical fields directly working with stability studies.

    + Bachelor of Science in Chemistry, Biology or related field.

    + Knowledge of FDA requirements and experience with FDA interactions as part of the 510k/ANDA/NDA approval processes.

    + Experience with risk assessment and root cause analysis.

    + Strong problem-solving skills and ability to manage various concrete variables.

    Additional Skills & Qualifications

    + Ability to communicate effectively with internal and external business partners.

    + Self-starter, independent worker, detail-oriented with critical thinking skills.

    + Excellent organizational, analytical, and problem-solving skills.

    Work Environment

    This role is based in a state-of-the-art 72,000 square foot lab facility. The position offers an office environment located above the laboratory with interactions across various groups including design and verification, R&D, Microbiology, and Chemistry. Initially, the job requires a 9am-5pm office presence for the first month, transitioning to a hybrid schedule of 3 days onsite and 2 days remote. The office is located within an hour's distance from the Chicago area, offering flexibility with fully remote options or minimal office presence post-training.

     

    Job Type & Location

     

    This is a Contract to Hire position based out of Mundelein, IL.

    Pay and Benefits

    The pay range for this position is $35.00 - $45.00/hr.

     

    Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: • Medical, dental & vision • Critical Illness, Accident, and Hospital • 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available • Life Insurance (Voluntary Life & AD&D for the employee and dependents) • Short and long-term disability • Health Spending Account (HSA) • Transportation benefits • Employee Assistance Program • Time Off/Leave (PTO, Vacation or Sick Leave)

     

    Workplace Type

     

    This is a fully onsite position in Mundelein,IL.

     

    Application Deadline

     

    This position is anticipated to close on Jan 17, 2026.

    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.