Research Scientist PI - Bioanalytical

• *Work Schedule** Standard (Mon-Fri)

• *Environmental Conditions**

Office This is a fully remote role supporting one of our key customers. We welcome applicants from all locations within the US. Must be legally authorized to work in the United States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission – to enable our customers to make the world healthier, safer, and cleaner. Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to leverage the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits. The Research Scientist acts as the sponsor representative/study monitor for one or more studies and supports the bioanalytical study phases of clinical trials.

• *Key responsibilities:
• Reviews trial related documentation with a link to the GxP vendor (i.e., CTP, SAP, TLF’s, CSR, Lab manual)
• Ensures the bioanalytical vendor receives copies of trial related documentation and relevant amendments (e.g., clinical trial protocol)
• Reviews and approves study plans of bioanalytical phases of clinical trials
• Reviews and approves (if applicable) bioanalytical reports
• Oversees planned and unplanned changes to study plan and vendor procedures are documented according to vendor procedures (e.g., in amendments and deviations) and are shared with the sponsor as stipulated in the quality agreement or communication plan
• Ensures that the Clinical Trial Team is adequately informed of the project status and that relevant information (e.g., end-of-study timelines and data delivery requirements) from the Clinical Trial Team is conveyed to the project manager and bioanalytical vendor
• Escalates issues related to timelines, budget or communication to the appropriate stakeholders
• Manages oversight documentation in eTMF
• Contributes to interactions with regulatory agencies (if applicable)
• *Education and Experience:
• PhD in Immunology or Molecular Biology and previous experience in the field of life sciences that provides the knowledge, skills, and abilities to perform the job comparable to 4+ years
• OR
• Master’s Degree and previous experience in the field of life sciences that provides the knowledge, skills, and abilities to perform the job comparable to 6+ years
• OR
• Bachelor's Degree and previous experience in the field of life sciences that provides the knowledge, skills, and abilities to perform the job comparable to 8+ years In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
• *Knowledge, Skills and Abilities:**

• Experience in managing outsourced activities at external vendors required

• Strong knowledge of bioanalytical techniques specifically in biologics and antibodies assays required
• Experience performing PK and ADA assays required
• Experience in analyzing human samples in support of clinical trials required
• Strong understanding of GCP/GCLP guidelines and other current global regulations required
• Experience with submission documentation and regulatory interactions
• Experience with clinical immunogenicity data interpretation, writing and reviewing the Integrated Summary of Immunogenicity (ISI) and clinical study report
• Experience drafting and reviewing bioanalytical modules (2.7.1, 2.7.2) and immunogenicity sections in regulatory documents either independently or collaboration with a medical writer

Working Environment Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.

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