Associate Director AS&T Manufacturing Network

BioNTech•Gaithersburg, MD

59d

About The Position

As Analytical Transfer Lead (Associate Director AS&T Manufacturing Network), you will be making a meaningful contribution to the ongoing development of our product pipeline as part of the Analytical Sciences and Technology (AS&T) team. In this role, you will be the main contact (SPoC) for analytical transfers at Contract Manufacturing Organizations (CMOs), Contract Testing Organizations (CTOs) and our internal sites. Furthermore, you will lead analytical transfers and the on-boarding into our BioNTech manufacturing- and testing- network, as well as the support of routine operations.

Requirements

University degree in biology, chemistry, pharmacy, biotechnology or comparable OR advanced degree in life science or healthcare (or equivalent)
Several years of working experience in a regulated environment in Biotechnology or Pharmaceutical Industry, ideally under GMP, and good knowledge of the standard quality processes (OOS, deviations, Change control, CAPAs)
Experience in leading analytical transfers covering method implementation, optimization, trouble shooting and validation, ideally in QC within the pharmaceutical industry
Knowledge in analytics of therapeutic proteins (e.g. antibodies, ADCs), especially regarding analytical chemistry (e.g. HPLC), bioassays and/or ELISAs
Excellent organizational skills, with the ability to manage multiple priorities and deliver results in a fast-paced environment
Highly conscientious, detail-oriented, and problem-solving approach
Effective communication skills (verbal and written), supportive team player, and excellent collaborating and stakeholder management skills

Nice To Haves

Experience in managing analytical/ QC aspects at external partners (CMOs)
Knowledge of relevant US, EU, EMA and FDA regulatory standards

Responsibilities

Defining, maintaining, and facilitating the communication line between internal departments and sites and external collaboration partners and CMOs and supporting compliance and harmonization of analytical testing strategies as the main contact of CMOs/ new sites during on-boarding and/or transfer
Leading analytical technology transfer projects in the internal and external manufacturing network
Conducting analytical investigations and problem-solving activities during technology transfer and routine production
Overseeing the creation/revision and approval of work instructions, transfer/validation documentation and other supporting documents
Supporting the evaluation and implementation of new technologies required to maintain state-of-the-art analytical methods for development in alignment with internal and external stakeholders
Providing support for troubleshooting and continuous improvement in the laboratory