Senior Scientist - Immunoassay
* Responsible for the design, development, and validation (both internal and external at CROs) of a broad range of bioanalytical assays including Immunoassays (PK, ADA, and biomarker) and activity or cell-based neutralizing antibody assays to support in accordance with appropriate global regulatory guidance.
* Schedule activities in accordance with line function and program/corporate goals/assignments and priorities supporting Discovery, Nonclinical and Clinical programs.
* Represent Bioanalytical and Biomarker Development group in project/program team meetings to ensure timely communication and delivery of high quality bioanalytical and biomarker data results.
* Manage both internal and external work, including interactions with technical and administrative staff at CROs or external vendors.
* Introduce innovative approaches/technology platforms in assay development and apply them across multiple programs.
* Actively network and collaborate with colleagues within and outside of Research & Non-clinical Department.
* Author or contribute to Clinical Study Report sections, regulatory documents and abstracts/manuscripts for publication. Review assay validation and bioanalytical reports.
60% Design, develop, and implement high complexity bioanalytical test methods (PK, anti-drug antibody, biomarkers, etc) in compliance with GLP/CLIA and regulatory guidance to support Research, Non-clinical, and Clinical studies.
10% Perform quality review of assay results and data entry.
10% Write and review technical and data analysis reports, and maintain accurate, precise, legible documentations.
10% Manage external vendors/CROs.
10% Assess progress relative to objectives and communicates progress periodically to supervisor and key stakeholders within and outside Group.
Education and Experience Requirements:
* PhD in life science with 5+ years of industry experience
* Experience in developing and validating (GLP or GMP or CLIA) analytical and/or bioanalytical test methods required.
* Experience with development, validation and performance of bioanalytical assay methods in a regulated Good Laboratory Practices (GLP) and/or Good Manufacturing Practices (GMP) environment is required.
* Experience in placing and managing external work at CROs or CMOs is preferred.
Key Skills, Abilities, and Competencies:
* Hands on experience and proficiency with the use of various bioanalytical tools including but not limited to ELISA, MSD, Western, enzymatic assays, cell-based assays, nucleotide hybridizations techniques, etc.
* Ability to design assay development experiments and troubleshoot assay development independently
* Excellent management and organizational skills, and attention to detail, are essential.
* Cross/inter-departmental representation experience, e.g., on project teams, is highly preferred. * Candidate must be highly independent and motivated, has excellent oral and written communication skills and ability to deliver results in a fast paced environment.
Shire's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives
As an Equal Opportunity and Affirmative Action Employer, Shire is committed to a diverse workforce. US Applicants who require accommodation in the job application process may contact 484-595-8400.
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