Job Summary (Primary function)
Essential Functions of the Job (Key responsibilities)
·Develop strategy to deliver an acceptable and product specific analytical package to support clinical studies from Phase 1 to BLA.
·Write, review and approve analytical and stability sections for regulatory filing.
·Profound scientific knowledge in structure-function analysis of antibody molecules.
·Establish release vs. shelf-life specifications and justification of specification.
·Manage Biologics Analytical Services resources, develop and maintain a strong collaboration with development team, internal cross-functional stakeholders, and external partners, including managing oversight of analytical operations at external sites.
·Lead clinical and commercial phase-specific product characterization and comparability studies required for regulatory filing.
·Perform batch release and stability trending analysis and ensure OOT and OOS are adequately investigated.
·Develop fit-to-phase plans for method validation and transfer.
·Responsible for department analytical-related guidance and procedures (i.e. SOP, etc.)
Qualifications (Minimal acceptable level of education, work experience, and competency)
·PhD in biochemistry, biochemical engineering, chemistry or equivalent.
·10+ years of experience in biotechnology or pharmaceutical industry with a track record of leadership and success.
·Solid scientific knowledge of a variety of analytical methods used for antibody quality control testing.
·Proficient in study design, protocol and technical report writing and review.
·Ability to lead and manage a diverse team.
·Strong and current knowledge of GMP requirements.
·Good inter-personal skill to work with regulatory, QA, QC, CRO and CMO.
·In-depth knowledge on analytical method development, qualification, method transfer and validation.
·Knowledge in antibody and bio-specific drug development.
·Experience in management of out-sourced manufacturing/development activities.
·Familiar with ICH guidelines associated with life cycle management.
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.
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