This is a hands-on, non-supervisory role that serves as the site subject matter expert on product reference standards used for analysis of an antibody drug conjugate product. In this role, the incumbent will provide technical expertise on the characterization, qualification and release of representative batches of antibody intermediate, drug linker, drug substance and drug product for use as reference standard, including development of protocols, review and release of test results and control of inventory.
In conjunction with the Director of Quality Control Technical Sciences, this technical subject matter expert in characterization of biomolecules develops and maintains the reference standards program in compliance with regulatory guidelines, ensuring that a continuous supply of fully qualified materials are available for GMP release and stability testing.
Authors and maintains program level documents, develops specifications and qualification documents required for release.
Develops detailed protocols for full characterization, coordinates all testing and compiles comprehensive reports supporting release of reference standards,
Includes responsibility for the identification of source materials (manufactured in-house and externally) for use in filling product reference standards.
Tracks inventory and collaborates with Supply Chain, internal and external contract laboratories to ensure continuity of supply. Manages the reference standards inventories throughout the life-cycle with appropriate supporting documentation (e.g. change management).
ProvideVerifies compliance with applicable policies and guidelines and ensures consistency among site procedures and/or specifications.s technical support for monitoring and evaluating the performance of analytical methods that include the use of reference standards to demonstrate method suitability.
Ensures that all QC personnel have adequate training in the handling and use of reference standards to effectively execute testing.
Participates in compliance-focused teams working towards the goal of continuous improvement of the reference standards program.
Participates in the site team which authors, hosts and responds to regulatory inspections, reviews and approvals of the facility and products.
PhD. degree in Biochemistry, Molecular Biology or a related field and three (3) years, or M.S. degree and five (5) years of relevant experience in analytical development for biotherapeutics.
Experience in a regulated biopharmaceutical environment with analysis of biological molecules is preferred.
Direct experience with reference standards development, manufacture and control is a plus.
Experience with pharmaceutical and biotechnology product development. Must be a technical/scientific expert in analytical methods commonly applied to protein characterization, including stability assessment and determination of degradation pathways.
Ability to write technical reports related to material characterization and reference standard evaluations.
Familiarity with regulatory guidance documents from FDA, EMEA and ICH.
Able to operate independently where appropriate, yet escalate issues as appropriate, establishes effective cross functional working relationships.
Well-developed organizational, interpersonal communications, negotiation, writing, and strong listening skills.
Must have ability to prioritize and manage multiple, concurrent projects with often long life cycles.
Must have expert authorship of technical documents. Must be able to recognize the impact beyond a single site, project or collaboration.
Must have strong verbal, technical writing and presentation skills.