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    Scientist Iii - Biopharmaceuticals

    Thermo Fisher Scientific
    5+ years
    Not Disclosed
    Middletown Remote, USA
    10 Dec. 11, 2024
    Job Description
    Job Type: Full Time Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

    Job Title: Scientist III
    Location: Middleton, WI GMP Lab
    Department: Biopharmaceutical Lab
    Work Schedule: Standard (Mon-Fri)
    Environmental Conditions: Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office, Some degree of PPE (Personal Protective Equipment) required (e.g., safety glasses, gowning, gloves, lab coat, ear plugs)

    Job Description:
    At Thermo Fisher Scientific, we are dedicated to making the world healthier, cleaner, and safer. As part of our mission, we provide impactful work that allows you to thrive and contribute to global health. We offer our teams the resources they need to advance their careers while contributing to life-changing therapies, clinical trials, and research initiatives in 100+ countries.

    Our PPD® Laboratory Services team plays a key role in improving patient health, and as a Scientist III, you will directly contribute to this effort. This position involves performing complex laboratory analyses of pharmaceutical products and using analytical instrumentation to collect and analyze data in compliance with PPD SOPs and industry standards. As a project leader, you will manage multiple projects, work with clients, and ensure that all scientific activities are conducted according to regulatory requirements and industry standards.

    Key Responsibilities:

    • Perform analytical method development, optimization, and validation, as well as other specialty technology studies.
    • Conduct complex sample preparation and analysis procedures across multiple functional groups.
    • Plan and organize work, ensuring tasks are completed with periodic supervision.
    • Set up and maintain analytical instrumentation, and train team members on operating, maintaining, and understanding the theory behind analytical instrumentation.
    • Ensure QA findings are addressed appropriately and communicate project status to project leaders.
    • Review, interpret, and analyze data for technical, quality, and compliance to protocols, methods, SOPs, client criteria, and GMP or GLP.
    • Provide assistance and training to junior team members and contribute to the timely and safe completion of work assignments.

    Education and Experience:

    • Bachelor's degree or equivalent in a relevant field.
    • 5+ years of experience (or 3+ years with a Master’s degree) or PhD.
    • Experience with analytical techniques such as HPLC, CE, iCE, or ELISA is preferred.
    • Strong knowledge of laboratory requirements, PPD & client SOPs, ICH guidelines, GMP, and FDA guidance.

    Skills and Abilities:

    • Proficiency in Microsoft Excel and Word.
    • Strong technical problem-solving and troubleshooting abilities.
    • Effective oral and written communication skills.
    • Proven ability in technical writing.
    • Time management and project management skills.
    • Ability to work collaboratively in a team environment.
    • Experience in training junior staff.

    Work Environment:

    • Communicate effectively with diverse groups and understand complex information.
    • Ability to stand or work upright for long periods and lift objects up to 25 pounds.
    • Exposure to potentially hazardous materials, including infectious agents.
    • Ability to perform successfully under pressure and prioritize multiple tasks.

    Our Mission:
    At Thermo Fisher Scientific, we work together to enable our customers to make the world healthier, cleaner, and safer. As part of our team, you'll contribute to accelerating research, solving scientific challenges, and driving technological innovation.

    Apply Today:
    Jobs at Thermo Fisher

    Accessibility/Disability Access:
    Thermo Fisher Scientific offers accessibility services for job seekers requiring accommodations during the application process. If you need assistance, please contact 1-855-471-2255 to request support.

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