Associate Director, AS&T Lifecycle Management (Chemical Method Expert)

BioNTech•Gaithersburg, MD

1d•$146,300 - $234,100•Onsite

About The Position

As the 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 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 Biology, Chemistry, Pharmacy, Biotechnology, or a related field with 10+ years in a regulated environment in the pharmaceutical industry
Comprehensive expertise in analytical methods specific for ADCs: Drug-to-antibody ratio, Free drug, Residual impurities, Unconjugated antibody, Conjugate variants, Conjugated small molecule impurities, Charge variants; additionally beneficial: HPLC, GC, Mass spectrometry, NMR, and IR techniques for the analysis of Linker-payload intermediate
Hands-on experience with assay development, design and performance of method validations, as well as data analysis and statistical evaluation
Strong background in CMC activities for late-stage development and commercial biological products
In-depth knowledge of ICH guidelines, GMP regulations, and industry best practices
Proven experience with regulatory filings for biologicals (IND/IMPD, BLA/MAA) and interactions with health authorities
Experience in working in intercultural, cross-functional, and global 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

Nice To Haves

Experience managing method validation and transfer activities across external partners.
Demonstrated ability to lead and support QC quality events and root cause investigations.

Responsibilities

Provide technical analytical expertise for analytical activities of the Gaithersburg antibody laboratory, and for late-stage and commercial projects across a global network
Responsible for the design and performance of method validations and transfers as well as method lifecycle activities (e.g. exchange of critical reagents, method performance and laboratory investigations); potential hands-on work in the laboratory required
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