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.