Analytical Method Expert (Associate Director AS&T Lifecycle Management)

BioNTech•Gaithersburg, MD

66d

About The Position

As Analytical Method Expert (Associate Director AS&T Lifecycle Management), you will be making a meaningful contribution to the ongoing product development and regulatory submission (BLA/MAA) of our RNA and Protein-based therapeutic pipeline as part of our Analytics, Science & Technology (AS&T) department. In this role, you will be the main point of contact for specific methods within your area of expertise. You will ensure that the analytical methods comply with GMP standards and provide accurate, precise, and reliable results.

Requirements

An advanced university degree in a scientific discipline (Biology, Chemistry, Pharmacy, Biotechnology, or comparable)
Industry experience (5+ years) in CMC development/commercial
Background in organic chemistry (synthesis of small molecules and/or analytical chemistry) and/or Biologics product development
In-depth knowledge of analytical techniques in one of the following fields, with hands-on experience in assay development and validation, as well as data analysis and statistical evaluation: HPLC, GC, mass spectrometry, NMR, and IR techniques for the analysis of small molecules Chromatographic, spectroscopic, electrophoretic, immunoassay and molecular biology techniques for the analysis of mAbs/ADCs Cell-based and immunoassays, as well as molecular biology and physicochemical techniques for determining potency and biological activity, which reflect the mechanism of action of a product
Expertise in the definition of analytical control strategies, method validation concepts, and setting specifications for biologics and/or small molecules
Experience in working in intercultural, cross-functional teams
Structured way of working, ability to understand and break down complex challenges and plan associated timelines and interdependencies
Highly motivated and willingness to work in a fast-paced and fast-evolving environment

Responsibilities

Provide technical analytical expertise for late-stage and commercial projects in compliance with GMP standards and in accordance with relevant industry guidelines
Responsible for method validation and transfer strategies as well as method lifecycle activities (e.g. exchange of critical reagents, method performance and laboratory investigations)
Participate in strategic and technical discussions within projects cross-functionally with CMC team members and external partners
Evaluation and review of technical and regulatory submission documents in a timely manner for the approval and market launch of development products
Act as analytical SME by providing expert knowledge for regulatory filings, as well as contributing expertise to questions from health authorities and responses to regulatory submissions