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Principal Scientist Biochemical Assay Development

  • Job type: Permanent
  • Location: Princeton, New Jersey
  • Salary: Negotiable
  • Job reference: 173241/002_1533748320
  • Sector: Pharmacology, EPM Scientific
  • Date posted: 08/08/2018

Cutting-edge Biologics Manufacturer seeking: Principal Scientist, Biochemical Assay Development.

Responsibilities:

  • Serve as subject matter expert and lead all biochemical assay development and validation activities including the planning and execution of master method validation plan.

  • Support process development enabling activities including in-process sample, drug substance, drug product testing and extended characterization, comparability study.

  • Perform non-routine testing to support the process development and stability evaluation.

  • Perform data review to ensure accuracy, completeness, and validity.

  • Manage and coach junior scientists' method development and validation activities.

  • Support Quality Control for resolution of OOS and OOT results.

  • Keep real-time experiment records in ELN and prepare documents (SOP, protocol, report).

  • Contribute to the departmental activities such as new instrument purchasing, laboratory safety inspections, internal audits, and regulatory inspections.

  • Represent the group in project team meetings to support the development of monoclonal antibody biosimilars.

  • Support the established regulatory plan with respect to compliance with FDA/EMA/ROW.

  • Champion the Biochemical group's effort to maintain focus on established technologies while continuing to evaluate and implement appropriate, cutting edge technologies.

  • Author appropriate CTD sections for submission to regulatory agencies, including premarket notification submissions, premarket approval applications, and post-marketing submissions.

  • Represent the Company before EU and FDA regulatory authorities.

Requirements:

  • PhD in Chemistry/Biochemistry.

  • Minimum 10 years of progressive industry experience in analytical laboratories in biotechnology or biopharmaceutical industry.

  • Minimum 3 years of hands-on and leadership experience in validation of methods appropriate for late stage protein therapeutic development.

  • Hands-on experience in HPLC/UPLC (e.g. SEC, SEC-MALS, CEX, HILIC, affinity chromatography), SDS-PAGE, capillary electrophoresis (e.g., CE-SDS, cIEF), spectroscopy (UV/VIS), glycan analysis, isolation of charge variants, residual impurity analysis (e.g., ELISA, qPCR).

  • A clear understanding of method development and validation requirements per international regulatory guidelines.

  • A thorough understanding of protein structure, chemistry, stability attributes, structure-function relation.

  • Experience in statistical evaluation of method validation data.

  • An ability to effectively and collaboratively participate in team discussions (e.g., communication of test results, OOT results, scientific principles).

  • An ability to work independently with little supervision and be flexible with changing project timeline to support the process development.

  • Experience in the analysis of monoclonal antibody or the late stage biologics support is desirable.

  • Familiarity with CMC and GMP is desirable.

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