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Thermo Fisher Scientific · 6 hours ago

Research Scientist PI - Bioanalytical

United States

Full-time

Remote

Mid, Senior Level

3+ years exp

Thermo Fisher Scientific is a leading global contract research organization dedicated to serving science. The Research Scientist will act as the sponsor representative and support the bioanalytical phases of clinical trials, ensuring compliance with study plans and facilitating communication between stakeholders.

BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine

No H1B

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)

Qualification

PhD in ImmunologyBioanalytical techniquesPKADA assaysGCP/GCLP guidelinesRegulatory interactionsClinical immunogenicity dataBioanalytical modules draftingCommunication skillsProject management

Required

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

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 3+ 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

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

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